- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03367923
Health and Recovery Program in Increasing Physical Activity Level in Stage IA-IIIA Endometrial Cancer Survivors
November 21, 2023 updated by: Stanford University
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
47
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
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Palo Alto, California, United States, 94304
- Stanford University, School of Medicine
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San Jose, California, United States, 95124
- Stanford Cancer Center South Bay
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Other active cancer
- Receiving chemotherapy or other active treatment
- BMI < 60
- Diagnosis of uterine serous carcinoma or uterine sarcoma
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (exercise counseling, Fitbit, phone call)
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.
|
Ancillary studies
Other Names:
Ancillary studies
Undergo exercise counseling
Other Names:
Wear Fitbit tracker
Other Names:
Receive phone call
|
Experimental: Arm II (exercise counseling, Fitbit, email/text)
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.
|
Ancillary studies
Other Names:
Ancillary studies
Undergo exercise counseling
Other Names:
Wear Fitbit tracker
Other Names:
Receive email/text
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Up to week 20-28
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body mass index (BMI)
Time Frame: Up to 9 months
|
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.
|
Up to 9 months
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Pulse
Time Frame: Up to 9 months
|
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.
|
Up to 9 months
|
Blood pressure
Time Frame: Up to 9 months
|
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.
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Up to 9 months
|
Quality of life assessment using Functional Assessment of Cancer Therapy-General (FACT-G)
Time Frame: Up to 9 months
|
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.
|
Up to 9 months
|
Rate of increased activity level measured using Fitbit tracker
Time Frame: Up to week 20-28
|
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.
|
Up to week 20-28
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Rate of increased activity level measured using Fitbit tracker
Time Frame: Up to 9 months
|
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.
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Up to 9 months
|
Waist circumference
Time Frame: Up to 9 months
|
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
|
Up to 9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elizabeth Kidd, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2017
Primary Completion (Actual)
March 25, 2020
Study Completion (Actual)
March 25, 2020
Study Registration Dates
First Submitted
November 29, 2017
First Submitted That Met QC Criteria
December 4, 2017
First Posted (Actual)
December 11, 2017
Study Record Updates
Last Update Posted (Actual)
November 28, 2023
Last Update Submitted That Met QC Criteria
November 21, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-43094
- NCI-2017-02149 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- GYNEND0002 (Other Identifier: OnCore)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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