Bladder CancerTTBFNCT05056077
Improving Nutrition and Physical Activity for Cancer Survivors (Tools To Be Fit)
A study testing Counseling, Educational Intervention and Health Education in people with Bladder Cancer and Breast Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
This clinical trial studies the effect of four different intervention components "tools" on body weight, nutrition, and physical activity in cancer survivors. Studies indicate that people with a history of cancer whose nutrition and physical activity habits are consistent with the American Cancer Society's Nutrition… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Breast Cancer, Colon Cancer
- What is being tested?
- Counseling, Educational Intervention and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2021to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 18 years of age.
- Diagnosis of bladder, breast, colon, endometrial, kidney (renal cell carcinoma), ovarian, prostate, or rectal cancer.
- Completed all cytotoxic chemotherapy, immunotherapy, targeted therapies, or radiation (if indicated) prior to enrollment. Hormonal treatments are allowed.
- Owns a smart phone that has access to the Internet and can receive daily text messages.
- Able to speak and read English or Spanish
- Have a support person >= 18 years of age who speaks English or Spanish and is willing to provide informed consent and support the participant throughout the study.
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- >= 4 weeks since a major surgery to start of intervention (removal of port or catheter (cath) is not major surgery; reversal of ostomy is major surgery and will require at least 4 weeks prior to enrollment).
- Readiness, as determined by the Physical Activity Readiness Questionnaire (PAR-Q). If there are any indications that home-based exercise might be unsafe based on PAR-Q, the patient will not be enrolled until confirmation from the patient's provider is received via email and/or phone that they are safe to exercise. Providers do not need to be contacted if patients answer 'yes' to 'Is your doctor currently prescribing any medication for your blood pressure or for a heart condition?
- Identified by a cancer survivor participant who has consented to participate in Tools To Be Fit as their support person.
- 18 years of age or older.
- Speaks and reads English or Spanish.
- Consents to complete two online surveys and four 1-on-1 health coaching calls during the 48 week study.
Who cannot join
- People with potential contraindications to home-based exercise based on the PAR-Q for whom the investigator is unable to obtain physician clearance.
- ACS guideline score of > 4 out of 6 at enrollment based on self-reported diet, BMI, and physical activity. Our screening survey will ask participants to report their height and weight; usual intake of foods in the ACS guidelines (e.g., red and processed meat, fruits, vegetables, grains); and the Godin Leisure Time Exercise Survey.
- Used a physical activity tracker and a diet tracking app for >= 1 week in the past 3 months; these are components of our digital health tool kit.
- Planned major surgery during the study period (removal of port or cath or dermatological procedures excluded)
- Scheduled to receive any form of cancer therapy during the study period with the exception of hormonal treatments, which are allowed.
- History of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility.
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- History of psychiatric disorders that would preclude participation in the study intervention (e.g., untreated major depression or psychosis, substance abuse, severe personality disorder) or prevent the patient from giving informed consent.
- Participating in another weight loss, physical activity or dietary intervention clinical trial. Co-enrollment in some trials involving pharmacologic therapy is allowed. Participants are also allowed to pursue weight loss and physical activity programs on their own, as long as these programs are not provided as part of a clinical trial.
- Currently pregnant or trying to become pregnant during the study period.
- Living outside the United States during screening and/or the 48-week study period.
- 1. None.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Optimizing Intervention Tools to Improve Nutrition and Physical Activity for Cancer Survivors (Tools To Be Fit)
This clinical trial studies the effect of four different intervention components "tools" on body weight, nutrition, and physical activity in cancer survivors. Studies indicate that people with a history of cancer whose nutrition and physical activity habits are consistent with the American Cancer Society's Nutrition and Physical Activity Guidelines may have longer disease-free survival. The four different intervention components may help patients with a history of cancer adopt recommended health behaviors after they have completed treatment.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the effect of four candidate intervention components (text messaging, digital health tool kit, health coaching, or support person training), and combinations of the four intervention components, on change cancer survivors' American Cancer Society (ACS) guideline score after 48 weeks of intervention.
SECONDARY OBJECTIVES:
- To determine the effect of four candidate intervention components (text messaging, digital health tool kit, health coaching, or support person training), and combinations of the four intervention components, on cancer survivors' American Cancer Society (ACS) guideline score after 24 weeks of intervention.
II. To determine the effect of four candidate intervention components, and combinations of the four intervention components, on cancer survivors' intake of fruits and vegetables, whole grains, refined grains, red meat, and processed meats; moderate-to-vigorous physical activity; and body mass index (BMI) after 48 weeks of intervention.
EXPLORATORY OBJECTIVES:
- To determine the effect of four candidate intervention components (text messaging, digital health tool kit, health coaching, or support person coaching), and combinations of the four intervention components, on cancer survivors' American Cancer Society (ACS) guideline score after 12 weeks of intervention.
II. To describe adherence to each intervention component.
III. To explore the effects of each of the candidate intervention components (text messaging, digital health tool kit, health coaching, support person training) on theoretical constructs (e.g., self-efficacy, outcome expectations, self-monitoring, social support) from 0 to 24 and 48 weeks.
IV. To explore whether sociodemographic (e.g., gender, age, race/ethnicity), clinical (e.g., stage of disease, treatment history, ostomy status, time since diagnosis), and/or psychological/behavioral (e.g., self-efficacy, social support, outcome expectations, depression) factors moderate the intervention components' effects on ACS guideline scores.
VII. To explore change in ACS guideline score in relation to change in fasting insulin, glucose, homeostatic model assessment (HOMA-IR), and inflammatory markers (e.g., Interleukin 6 (IL-6), high-sensitivity C-reactive protein (hs-CRP), Tumor Necrosis Factor alpha (TNF-alpha) for a subset of participants from enrollment to 48 weeks among people with a history of cancer.
VIII. To explore change in ACS guideline score in relation to change in fatigue, depression, and sleep quality from 0 to 24 and 48 weeks among people with a history of cancer.
IX. To explore changes in the ACS guideline score in relation to change in the gut microbiome among a subset of participants with a history of cancer.
- To describe cancer survivors' 10-year cardiovascular risk using the American Heart Association (AHA) Predicting Risk of cardiovascular disease (CVD) EVENTS (PREVENT) score.
XI. Engage stakeholders to identify opportunities for continued optimization of the intervention and prepare for future implementation.
XII. To explore whether aspects of the social or built environment moderate effects of the intervention components on the ACS guideline score
OUTLINE: All patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients are randomized to 1 of 16 conditions. Participants who consent to complete an end-of-study interview may be asked to complete the interview up to 24 weeks after the end of the intervention.
CONDITION I: Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
CONDITION II: Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 each for 48 weeks.
CONDITION III: Patients receive text messages and use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
CONDITION IV: Patients receive text messages and use digital health tool kit for 48 weeks.
CONDITION V: Patients receive text messages for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
CONDITION VI: Patients receive text messages for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.
CONDITION VII: Patients receive text messages for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
CONDITION VIII: Patients receive text messages for 48 weeks.
CONDITION IX: Patients use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
CONDITION X: Patients use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.
CONDITION XI: Patients use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
CONDITION XII: Patients use digital health tool kit for 48 weeks.
CONDITION XIII: Patients receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
CONDITION XIV: Patients receive 13 health coaching sessions over 30 minutes each for 48 weeks.
CONDITION XV: Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
CONDITION XVI: Patients receive personal report and booklet only.
- Conditions
- Bladder Cancer, Breast Cancer, Colon Cancer, Endometrial Cancer, Ovarian Cancer, Rectal Cancer
- Being tested
- Counseling, Educational Intervention, Health Education, Health Promotion and Education - Direct Text Messaging, Health Promotion and Education - Digital health tool kit
- Keywords
- Cancer Survivors, Nutrition
- Medical subject headings
- Urinary Bladder Neoplasms, Breast Neoplasms, Colonic Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms, Rectal Neoplasms, Prostatic Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingOther
Also called Counseling Intervention
Receive support person coaching
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive personal report and booklet on nutrition and physical activity for patients with a history of cancer
Health EducationBehavioural
Also called Health Coaching
Receive health coaching
Health Promotion and Education - Direct Text MessagingOther
Also called Text Messaging
Receive text messages
Health Promotion and Education - Digital health tool kitOther
Also called Educational, Digital health tool kit
Receive digital health tool kit
QuestionnairesOther
Also called Quality of Life Questionnaires
Quality of Life and Behavioral Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Condition I (text, health kit, health coach, support coach) | Experimental | Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30-45 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks. Receives: Other: Counseling; Other: Educational Intervention; Behavioral: Health Education; Other: Health Promotion and Education - Direct Text Messaging; Other: Health Promotion and Education - Digital health tool kit; Other: Questionnaires |
| Condition II (text, health kit, health coach) | Experimental | Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks. Receives: Other: Educational Intervention; Behavioral: Health Education; Other: Health Promotion and Education - Direct Text Messaging; Other: Health Promotion and Education - Digital health tool kit; Other: Questionnaires |
| Condition III (text, health kit, support coach) | Experimental | Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks. Receives: Other: Counseling; Other: Educational Intervention; Other: Health Promotion and Education - Direct Text Messaging; Other: Health Promotion and Education - Digital health tool kit; Other: Questionnaires |
| Condition IV (text, health kit) | Experimental | Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Receives: Other: Educational Intervention; Other: Health Promotion and Education - Direct Text Messaging; Other: Health Promotion and Education - Digital health tool kit; Other: Questionnaires |
| Condition IX (health kit, health coach, support coach) | Experimental | Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks. Receives: Other: Counseling; Other: Educational Intervention; Behavioral: Health Education; Other: Health Promotion and Education - Digital health tool kit; Other: Questionnaires |
| Condition V (text, health coach, support coach) | Experimental | Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Patients also receive 15 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks. Receives: Other: Counseling; Other: Educational Intervention; Behavioral: Health Education; Other: Health Promotion and Education - Direct Text Messaging; Other: Questionnaires |
| Condition VI (text, health coach) | Experimental | Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks. Receives: Other: Educational Intervention; Behavioral: Health Education; Other: Health Promotion and Education - Direct Text Messaging; Other: Questionnaires |
| Condition VII (text, support coach) | Experimental | Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks. Receives: Other: Counseling; Other: Educational Intervention; Other: Health Promotion and Education - Direct Text Messaging; Other: Questionnaires |
| Condition VIII (text) | Experimental | Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Receives: Other: Educational Intervention; Other: Health Promotion and Education - Direct Text Messaging; Other: Questionnaires |
| Condition X (health kit, health coach) | Experimental | Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks. Receives: Other: Educational Intervention; Behavioral: Health Education; Other: Health Promotion and Education - Digital health tool kit; Other: Questionnaires |
| Condition XI (health kit, support coach) | Experimental | Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks. Receives: Other: Counseling; Other: Educational Intervention; Other: Health Promotion and Education - Digital health tool kit; Other: Questionnaires |
| Condition XII (health kit) | Experimental | Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Receives: Other: Educational Intervention; Other: Health Promotion and Education - Digital health tool kit; Other: Questionnaires |
| Condition XIII (health coach, support coach) | Experimental | Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks. Receives: Other: Counseling; Other: Educational Intervention; Behavioral: Health Education; Other: Questionnaires |
| Condition XIV (health coach) | Experimental | Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive 13 health coaching sessions over 30 minutes each for 48 weeks. Receives: Other: Educational Intervention; Behavioral: Health Education; Other: Questionnaires |
| Condition XV (support coach) | Experimental | Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks. Receives: Other: Counseling; Other: Educational Intervention; Other: Questionnaires |
| Condition XVI (study booklet) | Experimental | Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Receives: Other: Educational Intervention; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in American Cancer Society (ACS) guideline score at 48 weeks
The ACS Guideline Score is comprised of scores on participant reported food intake (score range from 0-2), physical activity (score range from 0-2), and body mass index (BMI) (score range from 0-2). The total score is calculated by summing the scores on each component with a total score range from 0 to 6. Greater scores indicate a greater level of healthy choices made by the participant. The investigator will assess the independent and interaction effects of the four treatment components on change in ACS score as repeated measures and using a generalized linear mixed effect model, starting with the saturated model, including coefficients for main effects, interactions up to 3-way, and stratification variables (gender and age), and reduce the model via backward variable selection with a 0.05 significance level (alpha(α)=0.05) up to 48 weeks.
Measured: Up to 48 weeks
Secondary outcomes (3)
Mean change in ACS guideline score at 24 weeks
The ACS Guideline Score is comprised of scores on participant reported food intake (score range from 0-2), physical activity (score range from 0-2), and body mass index (BMI) (score range from 0-2). The total score is calculated by summing the scores on each component with a total score range from 0 to 6. Greater scores indicate a greater level of healthy choices made by the participant. The investigator will assess the independent and interaction effects of the four treatment components on change in ACS score as repeated measures and using a generalized linear mixed effect model, starting with the saturated model, including coefficients for main effects, interactions up to 3-way, and stratification variables (gender and age), and reduce the model via backward variable selection with a 0.05 significance level (α=0.05) up to 24 weeks.
Measured: Up to 24 weeks
Mean change in scores on the individual components of the ACS at 24 weeks
The ACS Guideline Score is comprised of individual factor scores on (1) participant reported food intake (score range from 0-2), (2) physical activity (score range from 0-2), and (3) body mass index (BMI) (score range from 0-2). Greater scores indicate a greater level of healthy choices made by the participant. The investigator will assess the independent and interaction effects of the four treatment components on change in the individual ACS guideline factors from 0 to 24 weeks using linear mixed-effects models adjusting for the stratification variables gender and age with the individual factor of interest as the outcome.
Measured: Up to 24 weeks
Mean change in scores on the individual components of the ACS at 48 weeks
The ACS Guideline Score is comprised of individual factor scores on (1) participant reported food intake (score range from 0-2), (2) physical activity (score range from 0-2), and (3) body mass index (BMI) (score range from 0-2). Greater scores indicate a greater level of healthy choices made by the participant. The investigator will assess the independent and interaction effects of the four treatment components on change in the individual ACS guideline factors from 0 to 48 weeks using linear mixed-effects models adjusting for the stratification variables gender and age with the individual factor of interest as the outcome.
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start21 Oct 2021
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of California, Davis, Robert H. Lurie Cancer Center, Dana-Farber Cancer Institute, American Heart Association
- Responsible party
- Sponsor
- Investigators
- Erin Van Blarigan, ScD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056077
- Sponsor's protocol ID
- 21456
- Other IDs
- NCI-2021-09059, R37CA248774
- Acronym
- TTBF
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2021
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with research collaborators during the course of the study.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Intervention Tools to Improve Nutrition and Physical Activity for Cancer Survivors (Tools To Be Fit)
- ClinicalTrials.gov ID
- NCT05056077
- Acronym / sponsor ID
- TTBF / 21456
- Conditions
- Bladder Cancer, Breast Cancer, Colon Cancer, Endometrial Cancer, Ovarian Cancer, Rectal Cancer
- Keywords
- Cancer Survivors, Nutrition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 353 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of California, Davis, Robert H. Lurie Cancer Center, Dana-Farber Cancer Institute, American Heart Association
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies the effect of four different intervention components "tools" on body weight, nutrition, and physical activity in cancer survivors. Studies indicate that people with a history of cancer whose nutrition and physical activity habits are consistent with the American Cancer Society's Nutrition and Physical Activity Guidelines may have longer disease-free survival. The four different intervention components may help patients with a history of cancer adopt recommended health behaviors after they have completed treatment.
Detailed description
PRIMARY OBJECTIVE:
- To determine the effect of four candidate intervention components (text messaging, digital health tool kit, health coaching, or support person training), and combinations of the four intervention components, on change cancer survivors' American Cancer Society (ACS) guideline score after 48 weeks of intervention.
SECONDARY OBJECTIVES:
- To determine the effect of four candidate intervention components (text messaging, digital health tool kit, health coaching, or support person training), and combinations of the four intervention components, on cancer survivors' American Cancer Society (ACS) guideline score after 24 weeks of intervention.
II. To determine the effect of four candidate intervention components, and combinations of the four intervention components, on cancer survivors' intake of fruits and vegetables, whole grains, refined grains, red meat, and processed meats; moderate-to-vigorous physical activity; and body mass index (BMI) after 48 weeks of intervention.
EXPLORATORY OBJECTIVES:
- To determine the effect of four candidate intervention components (text messaging, digital health tool kit, health coaching, or support person coaching), and combinations of the four intervention components, on cancer survivors' American Cancer Society (ACS) guideline score after 12 weeks of intervention.
II. To describe adherence to each intervention component.
III. To explore the effects of each of the candidate intervention components (text messaging, digital health tool kit, health coaching, support person training) on theoretical constructs (e.g., self-efficacy, outcome expectations, self-monitoring, social support) from 0 to 24 and 48 weeks.
IV. To explore whether sociodemographic (e.g., gender, age, race/ethnicity), clinical (e.g., stage of disease, treatment history, ostomy status, time since diagnosis), and/or psychological/behavioral (e.g., self-efficacy, social support, outcome expectations, depression) factors moderate the intervention components' effects on ACS guideline scores.
VII. To explore change in ACS guideline score in relation to change in fasting insulin, glucose, homeostatic model assessment (HOMA-IR), and inflammatory markers (e.g., Interleukin 6 (IL-6), high-sensitivity C-reactive protein (hs-CRP), Tumor Necrosis Factor alpha (TNF-alpha) for a subset of participants from enrollment to 48 weeks among people with a history of cancer.
VIII. To explore change in ACS guideline score in relation to change in fatigue, depression, and sleep quality from 0 to 24 and 48 weeks among people with a history of cancer.
IX. To explore changes in the ACS guideline score in relation to change in the gut microbiome among a subset of participants with a history of cancer.
- To describe cancer survivors' 10-year cardiovascular risk using the American Heart Association (AHA) Predicting Risk of cardiovascular disease (CVD) EVENTS (PREVENT) score.
XI. Engage stakeholders to identify opportunities for continued optimization of the intervention and prepare for future implementation.
XII. To explore whether aspects of the social or built environment moderate effects of the intervention components on the ACS guideline score
OUTLINE: All patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients are randomized to 1 of 16 conditions. Participants who consent to complete an end-of-study interview may be asked to complete the interview up to 24 weeks after the end of the intervention.
CONDITION I: Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
CONDITION II: Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 each for 48 weeks.
CONDITION III: Patients receive text messages and use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
CONDITION IV: Patients receive text messages and use digital health tool kit for 48 weeks.
CONDITION V: Patients receive text messages for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
CONDITION VI: Patients receive text messages for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.
CONDITION VII: Patients receive text messages for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
CONDITION VIII: Patients receive text messages for 48 weeks.
CONDITION IX: Patients use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
CONDITION X: Patients use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.
CONDITION XI: Patients use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
CONDITION XII: Patients use digital health tool kit for 48 weeks.
CONDITION XIII: Patients receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
CONDITION XIV: Patients receive 13 health coaching sessions over 30 minutes each for 48 weeks.
CONDITION XV: Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
CONDITION XVI: Patients receive personal report and booklet only.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Condition I (text, health kit, health coach, support coach) | Experimental | Other: Counseling, Other: Educational Intervention, Behavioral: Health Education, Other: Health Promotion and Education - Direct Text Messaging, Other: Health Promotion and Education - Digital health tool kit, Other: QuestionnairesPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30-45 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks. |
| Condition II (text, health kit, health coach) | Experimental | Other: Educational Intervention, Behavioral: Health Education, Other: Health Promotion and Education - Direct Text Messaging, Other: Health Promotion and Education - Digital health tool kit, Other: QuestionnairesPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks. |
| Condition III (text, health kit, support coach) | Experimental | Other: Counseling, Other: Educational Intervention, Other: Health Promotion and Education - Direct Text Messaging, Other: Health Promotion and Education - Digital health tool kit, Other: QuestionnairesPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks. |
| Condition IV (text, health kit) | Experimental | Other: Educational Intervention, Other: Health Promotion and Education - Direct Text Messaging, Other: Health Promotion and Education - Digital health tool kit, Other: QuestionnairesPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks. |
| Condition IX (health kit, health coach, support coach) | Experimental | Other: Counseling, Other: Educational Intervention, Behavioral: Health Education, Other: Health Promotion and Education - Digital health tool kit, Other: QuestionnairesPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks. |
| Condition V (text, health coach, support coach) | Experimental | Other: Counseling, Other: Educational Intervention, Behavioral: Health Education, Other: Health Promotion and Education - Direct Text Messaging, Other: QuestionnairesPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Patients also receive 15 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks. |
| Condition VI (text, health coach) | Experimental | Other: Educational Intervention, Behavioral: Health Education, Other: Health Promotion and Education - Direct Text Messaging, Other: QuestionnairesPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks. |
| Condition VII (text, support coach) | Experimental | Other: Counseling, Other: Educational Intervention, Other: Health Promotion and Education - Direct Text Messaging, Other: QuestionnairesPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks. |
| Condition VIII (text) | Experimental | Other: Educational Intervention, Other: Health Promotion and Education - Direct Text Messaging, Other: QuestionnairesPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. |
| Condition X (health kit, health coach) | Experimental | Other: Educational Intervention, Behavioral: Health Education, Other: Health Promotion and Education - Digital health tool kit, Other: QuestionnairesPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks. |
| Condition XI (health kit, support coach) | Experimental | Other: Counseling, Other: Educational Intervention, Other: Health Promotion and Education - Digital health tool kit, Other: QuestionnairesPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks. |
| Condition XII (health kit) | Experimental | Other: Educational Intervention, Other: Health Promotion and Education - Digital health tool kit, Other: QuestionnairesPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. |
| Condition XIII (health coach, support coach) | Experimental | Other: Counseling, Other: Educational Intervention, Behavioral: Health Education, Other: QuestionnairesPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks. |
| Condition XIV (health coach) | Experimental | Other: Educational Intervention, Behavioral: Health Education, Other: QuestionnairesPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive 13 health coaching sessions over 30 minutes each for 48 weeks. |
| Condition XV (support coach) | Experimental | Other: Counseling, Other: Educational Intervention, Other: QuestionnairesPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks. |
| Condition XVI (study booklet) | Experimental | Other: Educational Intervention, Other: QuestionnairesPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- >= 18 years of age.
- Diagnosis of bladder, breast, colon, endometrial, kidney (renal cell carcinoma), ovarian, prostate, or rectal cancer.
- Completed all cytotoxic chemotherapy, immunotherapy, targeted therapies, or radiation (if indicated) prior to enrollment. Hormonal treatments are allowed.
- Owns a smart phone that has access to the Internet and can receive daily text messages.
- Able to speak and read English or Spanish
Key exclusion criteria (11 listed)
- People with potential contraindications to home-based exercise based on the PAR-Q for whom the investigator is unable to obtain physician clearance.
- ACS guideline score of > 4 out of 6 at enrollment based on self-reported diet, BMI, and physical activity. Our screening survey will ask participants to report their height and weight; usual intake of foods in the ACS guidelines (e.g., red and processed meat, fruits, vegetables, grains); and the Godin Leisure Time Exercise Survey.
- Used a physical activity tracker and a diet tracking app for >= 1 week in the past 3 months; these are components of our digital health tool kit.
- Planned major surgery during the study period (removal of port or cath or dermatological procedures excluded)
- Scheduled to receive any form of cancer therapy during the study period with the exception of hormonal treatments, which are allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CounselingAlso: Counseling InterventionReceive support person coaching | Other | Condition I (text, health kit, health coach, support coach), Condition III (text, health kit, support coach), Condition IX (health kit, health coach, support coach), Condition V (text, health coach, support coach), Condition VII (text, support coach), Condition XI (health kit, support coach), Condition XIII (health coach, support coach), Condition XV (support coach) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive personal report and booklet on nutrition and physical activity for patients with a history of cancer | Other | Condition I (text, health kit, health coach, support coach), Condition II (text, health kit, health coach), Condition III (text, health kit, support coach), Condition IV (text, health kit), Condition IX (health kit, health coach, support coach), Condition V (text, health coach, support coach), Condition VI (text, health coach), Condition VII (text, support coach), Condition VIII (text), Condition X (health kit, health coach), Condition XI (health kit, support coach), Condition XII (health kit), Condition XIII (health coach, support coach), Condition XIV (health coach), Condition XV (support coach), Condition XVI (study booklet) |
| Health EducationAlso: Health CoachingReceive health coaching | Behavioural | Condition I (text, health kit, health coach, support coach), Condition II (text, health kit, health coach), Condition IX (health kit, health coach, support coach), Condition V (text, health coach, support coach), Condition VI (text, health coach), Condition X (health kit, health coach), Condition XIII (health coach, support coach), Condition XIV (health coach) |
| Health Promotion and Education - Direct Text MessagingAlso: Text MessagingReceive text messages | Other | Condition I (text, health kit, health coach, support coach), Condition II (text, health kit, health coach), Condition III (text, health kit, support coach), Condition IV (text, health kit), Condition V (text, health coach, support coach), Condition VI (text, health coach), Condition VII (text, support coach), Condition VIII (text) |
| Health Promotion and Education - Digital health tool kitAlso: Educational, Digital health tool kitReceive digital health tool kit | Other | Condition I (text, health kit, health coach, support coach), Condition II (text, health kit, health coach), Condition III (text, health kit, support coach), Condition IV (text, health kit), Condition IX (health kit, health coach, support coach), Condition X (health kit, health coach), Condition XI (health kit, support coach), Condition XII (health kit) |
| QuestionnairesAlso: Quality of Life QuestionnairesQuality of Life and Behavioral Questionnaires | Other | Condition I (text, health kit, health coach, support coach), Condition II (text, health kit, health coach), Condition III (text, health kit, support coach), Condition IV (text, health kit), Condition IX (health kit, health coach, support coach), Condition V (text, health coach, support coach), Condition VI (text, health coach), Condition VII (text, support coach), Condition VIII (text), Condition X (health kit, health coach), Condition XI (health kit, support coach), Condition XII (health kit), Condition XIII (health coach, support coach), Condition XIV (health coach), Condition XV (support coach), Condition XVI (study booklet) |
Primary outcome
Mean change in American Cancer Society (ACS) guideline score at 48 weeks
Time frame: Up to 48 weeks
The ACS Guideline Score is comprised of scores on participant reported food intake (score range from 0-2), physical activity (score range from 0-2), and body mass index (BMI) (score range from 0-2). The total score is calculated by summing the scores on each component with a total score range from 0 to 6. Greater scores indicate a greater level of healthy choices made by the participant. The investigator will assess the independent and interaction effects of the four treatment components on change in ACS score as repeated measures and using a generalized linear mixed effect model, starting with the saturated model, including coefficients for main effects, interactions up to 3-way, and stratification variables (gender and age), and reduce the model via backward variable selection with a 0.05 significance level (alpha(α)=0.05) up to 48 weeks.
3 secondary outcomes
Mean change in ACS guideline score at 24 weeks
Time frame: Up to 24 weeks
Mean change in scores on the individual components of the ACS at 24 weeks
Time frame: Up to 24 weeks
Mean change in scores on the individual components of the ACS at 48 weeks
Time frame: Up to 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with research collaborators during the course of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Van Blarigan, ScD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling, Educational Intervention and Health Education in people with Bladder Cancer and Breast Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in American Cancer Society (ACS) guideline score at 48 weeks (time frame: Up to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.