Breast CarcinomaNCT05132296
Mobile-Health Delivery of Lifestyle Interventions for Women With Breast Cancer
A study testing Behavioral Intervention, Best Practice and FitBit in people with Breast Carcinoma, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
This clinical trial aims to develop a lifestyle program to improve clinical outcomes in women with breast cancer who do not have a healthy diet, regular exercise habits, or ways to manage their stress well. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Behavioral Intervention, Best Practice and FitBit
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 May 2021to 15 Jun 2026
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with stage I-III BCa scheduled to undergo radiation therapy (RT) or within the first 12 months of having completed primary treatment (they do not need to have undergone RT)
- Underwent chemotherapy and surgery
- Able to read, write, and speak English
- BMI of 25 or higher
- 18 years of age or older
- Oriented to person, place, and time
Show all 14Show fewer
- Participants must meet at least two of the following criteria related to their lifestyle at the time of diagnosis:
- Consume less than 3 servings of fruit and vegetable/day
- Engage in less than 75 minutes of moderate/vigorous intensity activity per week, defined as anything that causes small increases in breathing or heart rate for a sustained amount of time (e.g., brisk walking, bicycling)
- Engage in a mind-body practice less than 4 times a month
- Access to internet connection
- Access to a tablet, laptop or computer
- Able to come to University of Texas (UT) MD Anderson or Wake Forest for blood collection
- Able to perform light physical activity. if any medical issues exist or arise that may limit performing physical activity, a medical release will be required
Who cannot join
- Have not completed chemotherapy; have a recurrent BCa diagnosis; another primary cancer diagnosis within past 5 years (not including non-melanoma skin cancers)
- Any major thought disorder (e.g., schizophrenia, dementia)
- Any major communication barriers that would preclude being able to complete the intervention (e.g., visually or hearing impaired)
- Poorly or uncontrolled diabetes in the opinion of the physician(s)
- Extreme mobility issues (e.g., unable to get in and out of a chair unassisted)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
M D Anderson Cancer Center
Houston, Texas, 77030
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Mobile-Health Delivery of Lifestyle Interventions for Women With Breast Cancer Multicenter Pilot Trial
This clinical trial aims to develop a lifestyle program to improve clinical outcomes in women with breast cancer who do not have a healthy diet, regular exercise habits, or ways to manage their stress well. The program will include support and counseling in healthy eating, physical activity, stress management and mindfulness, learning sleep hygiene techniques, and behavioral counseling in addition to social support. Developing a lifestyle program may help improve quality of life and encourage healthy lifestyle choices among patients diagnosed with breast cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- Assess the feasibility of delivering a mobile, standardized, comprehensive lifestyle program in women with breast cancer (BCa).
SECONDARY OBJECTIVES:
- Determine whether the comprehensive lifestyle intervention program (CLIP) group has reduction in body mass index (BMI) and percent body fat and weight over time.
II. Determine whether the CLIP group has improved outcomes in anthropometric measures, dietary patterns, and fitness measures and patient-reported outcomes including quality of life (QOL), fatigue, sleep disturbances, mental health, social support, and mindfulness.
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: Patients undergo 60 minute sessions of nutrition education for 12 weeks and behavioral intervention 26 weeks. Patients receive FitBit and undergo physical activity for 30-60 minutes 5 days a week (aerobic activity) and 2 days a week (resistance training).
GROUP II: Patients have access to all usual care supportive services.
- Conditions
- Breast Carcinoma
- Being tested
- Behavioral Intervention, Best Practice, FitBit, Nutrition Education, Physical Activity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Undergo behavioral counseling
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care supportive services
FitBitDevice
Receive FitBit
Nutrition EducationBehavioural
Receive nutrition education
Physical ActivityOther
Undergo physical activity
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| GROUP I (CLIP) | Experimental | Patients undergo 60 minute sessions of nutrition education for 12 weeks and behavioral intervention 26 weeks. Patients receive FitBit and undergo physical activity for 30-60 minutes 5 days a week (aerobic activity) and 2 days a week (resistance training). Receives: Behavioral: Behavioral Intervention; Device: FitBit; Behavioral: Nutrition Education; Other: Physical Activity; Other: Questionnaire Administration |
| GROUP II (usual care) | Active comparator | Patients have access to all usual care supportive services. Receives: Other: Best Practice; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the feasibility of delivering a mobile, standardized, comprehensive lifestyle program in women with BCa.
The feasibility criteria will include consent rate (how many patients are consented in a period of time), adherence rate ( how many patients adhere to the program and finish it), and study retention rate ( how many patients that are consented stay with the program until the end/ low number of participants withdrawing from the study after consent).
Measured: up to 9 months after study baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start21 May 2021
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lorenzo Cohen, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132296
- Sponsor's protocol ID
- 2020-1190
- Other IDs
- NCI-2021-08961, 2020-1190, UG1CA189824
- Status last verified
- Jun 2026
- First submitted
- 17 Sep 2021
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile-Health Delivery of Lifestyle Interventions for Women With Breast Cancer Multicenter Pilot Trial
- ClinicalTrials.gov ID
- NCT05132296
- Acronym / sponsor ID
- 2020-1190
- Conditions
- Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 May 2021 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 24 Nov 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 aims to develop a lifestyle program to improve clinical outcomes in women with breast cancer who do not have a healthy diet, regular exercise habits, or ways to manage their stress well. The program will include support and counseling in healthy eating, physical activity, stress management and mindfulness, learning sleep hygiene techniques, and behavioral counseling in addition to social support. Developing a lifestyle program may help improve quality of life and encourage healthy lifestyle choices among patients diagnosed with breast cancer.
Detailed description
PRIMARY OBJECTIVE:
- Assess the feasibility of delivering a mobile, standardized, comprehensive lifestyle program in women with breast cancer (BCa).
SECONDARY OBJECTIVES:
- Determine whether the comprehensive lifestyle intervention program (CLIP) group has reduction in body mass index (BMI) and percent body fat and weight over time.
II. Determine whether the CLIP group has improved outcomes in anthropometric measures, dietary patterns, and fitness measures and patient-reported outcomes including quality of life (QOL), fatigue, sleep disturbances, mental health, social support, and mindfulness.
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: Patients undergo 60 minute sessions of nutrition education for 12 weeks and behavioral intervention 26 weeks. Patients receive FitBit and undergo physical activity for 30-60 minutes 5 days a week (aerobic activity) and 2 days a week (resistance training).
GROUP II: Patients have access to all usual care supportive services.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP I (CLIP) | Experimental | Behavioral: Behavioral Intervention, Device: FitBit, Behavioral: Nutrition Education, Other: Physical Activity, Other: Questionnaire AdministrationPatients undergo 60 minute sessions of nutrition education for 12 weeks and behavioral intervention 26 weeks. Patients receive FitBit and undergo physical activity for 30-60 minutes 5 days a week (aerobic activity) and 2 days a week (resistance training). |
| GROUP II (usual care) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationPatients have access to all usual care supportive services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Women with stage I-III BCa scheduled to undergo radiation therapy (RT) or within the first 12 months of having completed primary treatment (they do not need to have undergone RT)
- Underwent chemotherapy and surgery
- Able to read, write, and speak English
- BMI of 25 or higher
- 18 years of age or older
Key exclusion criteria (5 listed)
- Have not completed chemotherapy; have a recurrent BCa diagnosis; another primary cancer diagnosis within past 5 years (not including non-melanoma skin cancers)
- Any major thought disorder (e.g., schizophrenia, dementia)
- Any major communication barriers that would preclude being able to complete the intervention (e.g., visually or hearing impaired)
- Poorly or uncontrolled diabetes in the opinion of the physician(s)
- Extreme mobility issues (e.g., unable to get in and out of a chair unassisted)
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 |
|---|---|---|
| Behavioral InterventionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyUndergo behavioral counseling | Behavioural | GROUP I (CLIP) |
| Best PracticeAlso: standard of care, standard therapyReceive usual care supportive services | Other | GROUP II (usual care) |
| FitBitReceive FitBit | Device | GROUP I (CLIP) |
| Nutrition EducationReceive nutrition education | Behavioural | GROUP I (CLIP) |
| Physical ActivityUndergo physical activity | Other | GROUP I (CLIP) |
| Questionnaire AdministrationAncillary studies | Other | GROUP I (CLIP), GROUP II (usual care) |
Primary outcome
Assess the feasibility of delivering a mobile, standardized, comprehensive lifestyle program in women with BCa.
Time frame: up to 9 months after study baseline
The feasibility criteria will include consent rate (how many patients are consented in a period of time), adherence rate ( how many patients adhere to the program and finish it), and study retention rate ( how many patients that are consented stay with the program until the end/ low number of participants withdrawing from the study after consent).
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 12 Jun 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Lorenzo Cohen, MD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention, Best Practice and FitBit in people with Breast Carcinoma, run by M.D. Anderson Cancer Center at 2 sites 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 14 inclusion and 5 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Assess the feasibility of delivering a mobile, standardized, comprehensive lifestyle program in women with BCa. (time frame: up to 9 months after study baseline). 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 12 Jun 2026.