Cancer SurvivorPhase 2NCT03367923
Health and Recovery Program in Increasing Physical Activity Level in Stage IA-IIIA Endometrial Cancer Survivors
A Phase 2 study testing Communication Intervention, Counseling and Fitbit tracker in people with Cancer Survivor and Endometrial Carcinoma, run by Stanford University at 2 sites in United States.
Trial summary
This randomized phase II trial studies how well a health and recovery program works in increasing physical activity level in stage IA-IIIA endometrial cancer survivors. Health and recovery program which includes exercise counseling, Fitbit tracker, and phone or email/text communication may increase the level of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivor, Endometrial Carcinoma, Stage I Uterine Corpus Cancer AJCC v7
- What is being tested?
- Communication Intervention, Counseling and Fitbit tracker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2017to 25 Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Stage IA-IIIA endometrial cancer patients with pathology reviewed at Stanford
- Patients must have undergone surgery as a part of their treatment for their endometrial cancer
- At least 3 months post treatment
- BMI > 25
- Life expectancy of at least one year
- Able to perform physical activity of walking
- Possession of a computer and/or smart phone and/or smart tablet
- Must be English or Spanish speaking
Who cannot join
- Other active cancer
- Receiving chemotherapy or other active treatment
- BMI < 60
- Diagnosis of uterine serous carcinoma or uterine sarcoma
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford University, School of Medicine
Palo Alto, California, 94304
Stanford Cancer Center South Bay
San Jose, California, 95124
About this study
Official title: Step Into Wellness: A Program of Health and Recovery for Endometrial Cancer Survivors
This randomized phase II trial studies how well a health and recovery program works in increasing physical activity level in stage IA-IIIA endometrial cancer survivors. Health and recovery program which includes exercise counseling, Fitbit tracker, and phone or email/text communication may increase the level of physical activity in endometrial cancer survivors and promote and maintain behavior change at a lower cost.
Read the detailed description
PRIMARY OBJECTIVES:I. Determine the increase in activity level per participant where the baseline average number of steps is recorded during week 0-2 will be compared to average step count recorded during week 20-28.SECONDARY OBJECTIVES:I. Determining the rate of patients who have achieved a 50% increase in activity level in each communication group (telephone versus [vs.] electronic).II. Demonstrate that the rate of patients who have achieved an increased activity level of 50% as compared to the patient's baseline in the electronic/email group is not inferior to the rate in the telephone group.III. Evaluate changes in body mass index (BMI), waist circumference, blood pressure and pulse for the whole group, by communication group (electronic vs. telephone), and by activity level.IV. Evaluate the changes in quality of life, as assessed by Functional Assessment of Cancer Therapy-General (FACT-G), during the course of the study for the whole group, between the two groups (electronic vs. telephone), and based on activity level.V. Evaluate maintenance of activity level at 9 month (m) (week 32-40) (comparison activity level 9 m vs. 6 m) for the whole group, by group (electronic vs. telephone), and by activity level.OUTLINE: Patients are randomized to 1 of 2 arms.ARM I: Participants undergo an exercise counseling session at baseline and wear Fitbit tracker daily for 9 months. Participants receive a short phone call at 2, 4, 6, and 8 weeks, and at 4 and 5 months to discuss the average number of daily steps over the past 2 weeks and to encourage a goal of a 10% increase over the next 2-4 week time period.ARM II: Participants undergo an exercise counseling session at baseline and wear Fitbit tracker daily for 9 months. Participants receive an electronic communication (email/text) of their choice at 2, 4, 6, and 8 weeks, and at 4 and 5 months stating the average number of daily steps over the past 2 weeks and encouraging a goal of a 10% increase over the next 2-4 week time period.
- Conditions
- Cancer Survivor, Endometrial Carcinoma, Stage I Uterine Corpus Cancer AJCC v7, Stage IA Uterine Corpus Cancer AJCC v7, Stage IB Uterine Corpus Cancer AJCC v7, Stage II Uterine Corpus Cancer AJCC v7
- Being tested
- Communication Intervention, Counseling, Fitbit tracker, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication InterventionOther
Receive email/text
CounselingOther
Also called Counseling Intervention
Undergo exercise counseling
Fitbit trackerOther
Also called Device
Wear Fitbit tracker
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Telephone-Based InterventionBehavioural
Receive phone call
| Study group | Role | What they receive |
|---|---|---|
| Arm I (exercise counseling, Fitbit, phone call) | Experimental | Participants undergo an exercise counseling session at baseline and wear Fitbit tracker daily for 9 months. Participants receive a short phone call at 2, 4, 6, and 8 weeks, and at 4 and 5 months to discuss the average number of daily steps over the past 2 weeks and to encourage a goal of a 10% increase over the next 2-4 week time period. Receives: Other: Counseling; Other: Fitbit tracker; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention |
| Arm II (exercise counseling, Fitbit, email/text) | Experimental | Participants undergo an exercise counseling session at baseline and wear Fitbit tracker daily for 9 months. Participants receive an electronic communication (email/text) of their choice at 2, 4, 6, and 8 weeks, and at 4 and 5 months stating the average number of daily steps over the past 2 weeks and encouraging a goal of a 10% increase over the next 2-4 week time period. Receives: Other: Communication Intervention; Other: Counseling; Other: Fitbit tracker; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in activity level measured using Fitbit tracker
The increase in activity level will be determined where the baseline average number of steps recorded per patient during week 0 - 2 will be compared to the average step count recorded during week 20 - 28. The baseline measurement will be defined as the average step count reported by the patient during 0-2 weeks. At each subsequent time point the average step count per patient will be the average of the step counts recorded during the 2-4 weeks prior to the follow up visit. The average step count measured at 20-28 weeks will be compared to the baseline in a paired t test. The paired t test will
Measured: Up to week 20-28
Secondary outcomes (7)
Body mass index (BMI)
BMI will be measured using the participant weight in kilograms over height (in meters) squared. Changes in BMI over time will be evaluated in a repeated measures model allowing for within patient correlation. The relationship between average step count and the BMI will be evaluated in a repeated measures model allowing for within patient correlation. Determining if there is a difference between the two groups in the relationship between step count and health measures outcome: BMI will also be evaluated in a repeated measures model allowing for within patient correlation.
Measured: Up to 9 months
Pulse
Pulse will be measured using an automated cuff while the participant is sitting. Changes in pulse over time will be evaluated in a repeated measures model allowing for within patient correlation.
Measured: Up to 9 months
Blood pressure
Blood pressure will be measured using an automated cuff while the participant is sitting. Changes in blood pressure over time will be evaluated in a repeated measures model allowing for within patient correlation.
Measured: Up to 9 months
Quality of life assessment using Functional Assessment of Cancer Therapy-General (FACT-G)
The relationship between average step count and quality of life will be evaluated in a repeated measures model allowing for within patient correlation. Determining if there is a difference between the two groups in the relationship between step count and quality of life will also be evaluated in a repeated measures model allowing for within patient correlation.
Measured: Up to 9 months
Rate of increased activity level measured using Fitbit tracker
For each patient, the average step count for the time period week 20 - 28 will be compared to the baseline (week 0-2) average step count. If the increase in step count is 50% or more the patient will have achieved an increased activity level. The proportion of patients who have achieved an increased activity level will be calculated for each arm.
Measured: Up to week 20-28
Rate of increased activity level measured using Fitbit tracker
For each patient, the average step count for the time period 6 months (weeks 20-28) will be compared to the baseline average step count. Likewise, for each patient the average step count for the time period 9 months (weeks 32-40) will be compared to the baseline average step count. The proportion of patients who have achieved an increased activity level will be calculated for each arm at each time period 6 months and 9 months.
Measured: Up to 9 months
Waist circumference
Waist circumference will be measured in centimeters at the level of the belly button while participant is standing. Changes in waist circumference over time will be evaluated in a repeated measures model allowing for within patient correlation. The relationship between average step count and the outcomes of: waist circumference will be evaluated in a repeated measures model allowing for within patient correlation. Determining if there is a difference between the two groups in the relationship between step count and health measures outcomes: waist circumference will also be evaluated in a repea
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start1 Dec 2017
- Primary completion25 Mar 2020
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Kidd, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367923
- Sponsor's protocol ID
- IRB-43094
- Other IDs
- NCI-2017-02149, GYNEND0002
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2017
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Step Into Wellness: A Program of Health and Recovery for Endometrial Cancer Survivors
- ClinicalTrials.gov ID
- NCT03367923
- Acronym / sponsor ID
- IRB-43094
- Conditions
- Cancer Survivor, Endometrial Carcinoma, Stage I Uterine Corpus Cancer AJCC v7, Stage IA Uterine Corpus Cancer AJCC v7, Stage IB Uterine Corpus Cancer AJCC v7, Stage II Uterine Corpus Cancer AJCC v7
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 11 Dec 2017 (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 randomized phase II trial studies how well a health and recovery program works in increasing physical activity level in stage IA-IIIA endometrial cancer survivors. Health and recovery program which includes exercise counseling, Fitbit tracker, and phone or email/text communication may increase the level of physical activity in endometrial cancer survivors and promote and maintain behavior change at a lower cost.
Detailed description
PRIMARY OBJECTIVES:I. Determine the increase in activity level per participant where the baseline average number of steps is recorded during week 0-2 will be compared to average step count recorded during week 20-28.SECONDARY OBJECTIVES:I. Determining the rate of patients who have achieved a 50% increase in activity level in each communication group (telephone versus [vs.] electronic).II. Demonstrate that the rate of patients who have achieved an increased activity level of 50% as compared to the patient's baseline in the electronic/email group is not inferior to the rate in the telephone group.III. Evaluate changes in body mass index (BMI), waist circumference, blood pressure and pulse for the whole group, by communication group (electronic vs. telephone), and by activity level.IV. Evaluate the changes in quality of life, as assessed by Functional Assessment of Cancer Therapy-General (FACT-G), during the course of the study for the whole group, between the two groups (electronic vs. telephone), and based on activity level.V. Evaluate maintenance of activity level at 9 month (m) (week 32-40) (comparison activity level 9 m vs. 6 m) for the whole group, by group (electronic vs. telephone), and by activity level.OUTLINE: Patients are randomized to 1 of 2 arms.ARM I: Participants undergo an exercise counseling session at baseline and wear Fitbit tracker daily for 9 months. Participants receive a short phone call at 2, 4, 6, and 8 weeks, and at 4 and 5 months to discuss the average number of daily steps over the past 2 weeks and to encourage a goal of a 10% increase over the next 2-4 week time period.ARM II: Participants undergo an exercise counseling session at baseline and wear Fitbit tracker daily for 9 months. Participants receive an electronic communication (email/text) of their choice at 2, 4, 6, and 8 weeks, and at 4 and 5 months stating the average number of daily steps over the past 2 weeks and encouraging a goal of a 10% increase over the next 2-4 week time period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (exercise counseling, Fitbit, phone call) | Experimental | Other: Counseling, Other: Fitbit tracker, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Behavioral: Telephone-Based InterventionParticipants undergo an exercise counseling session at baseline and wear Fitbit tracker daily for 9 months. Participants receive a short phone call at 2, 4, 6, and 8 weeks, and at 4 and 5 months to discuss the average number of daily steps over the past 2 weeks and to encourage a goal of a 10% increase over the next 2-4 week time period. |
| Arm II (exercise counseling, Fitbit, email/text) | Experimental | Other: Communication Intervention, Other: Counseling, Other: Fitbit tracker, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationParticipants undergo an exercise counseling session at baseline and wear Fitbit tracker daily for 9 months. Participants receive an electronic communication (email/text) of their choice at 2, 4, 6, and 8 weeks, and at 4 and 5 months stating the average number of daily steps over the past 2 weeks and encouraging a goal of a 10% increase over the next 2-4 week time period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Stage IA-IIIA endometrial cancer patients with pathology reviewed at Stanford
- Patients must have undergone surgery as a part of their treatment for their endometrial cancer
- At least 3 months post treatment
- BMI > 25
- Life expectancy of at least one year
Key exclusion criteria (4 listed)
- Other active cancer
- Receiving chemotherapy or other active treatment
- BMI < 60
- Diagnosis of uterine serous carcinoma or uterine sarcoma
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 |
|---|---|---|
| Communication InterventionReceive email/text | Other | Arm II (exercise counseling, Fitbit, email/text) |
| CounselingAlso: Counseling InterventionUndergo exercise counseling | Other | Arm I (exercise counseling, Fitbit, phone call), Arm II (exercise counseling, Fitbit, email/text) |
| Fitbit trackerAlso: DeviceWear Fitbit tracker | Other | Arm I (exercise counseling, Fitbit, phone call), Arm II (exercise counseling, Fitbit, email/text) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (exercise counseling, Fitbit, phone call), Arm II (exercise counseling, Fitbit, email/text) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (exercise counseling, Fitbit, phone call), Arm II (exercise counseling, Fitbit, email/text) |
| Telephone-Based InterventionReceive phone call | Behavioural | Arm I (exercise counseling, Fitbit, phone call) |
Primary outcome
Increase in activity level measured using Fitbit tracker
Time frame: Up to week 20-28
The increase in activity level will be determined where the baseline average number of steps recorded per patient during week 0 - 2 will be compared to the average step count recorded during week 20 - 28. The baseline measurement will be defined as the average step count reported by the patient during 0-2 weeks. At each subsequent time point the average step count per patient will be the average of the step counts recorded during the 2-4 weeks prior to the follow up visit. The average step count measured at 20-28 weeks will be compared to the baseline in a paired t test. The paired t test will
7 secondary outcomes
Body mass index (BMI)
Time frame: Up to 9 months
Pulse
Time frame: Up to 9 months
Blood pressure
Time frame: Up to 9 months
Quality of life assessment using Functional Assessment of Cancer Therapy-General (FACT-G)
Time frame: Up to 9 months
Rate of increased activity level measured using Fitbit tracker
Time frame: Up to week 20-28
Rate of increased activity level measured using Fitbit tracker
Time frame: Up to 9 months
Waist circumference
Time frame: Up to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
Related trials for Cancer Survivor
Recruiting
Exercise and Nutrition for Older Cancer Survivors and Their Support Person: The Vitality Study
Cancer Survivorship
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
RecruitingObservational study
Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy
Acute Ovarian Failure, Infertility
Active, not recruiting
A Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship
Childhood Cancer, Survivorship
Recruiting
Assessing the Feasibility of Web-based Insomnia Treatment Among Prostate Cancer Survivors
Insomnia
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.
Elizabeth Kidd principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Communication Intervention, Counseling and Fitbit tracker in people with Cancer Survivor and Endometrial Carcinoma, run by Stanford University 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 8 inclusion and 4 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: finished, as of the sponsor's last update on 28 Nov 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Increase in activity level measured using Fitbit tracker (time frame: Up to week 20-28). 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 28 Nov 2023.