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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Stanford University, School of Medicine
Palo Alto, California, United States
Stanford Cancer Center South Bay
San Jose, California, United States
Start Date
December 1, 2017
Primary Completion Date
March 25, 2020
Completion Date
March 25, 2020
Last Updated
November 28, 2023
47
ACTUAL participants
Communication Intervention
OTHER
Counseling
OTHER
Fitbit tracker
OTHER
Quality-of-Life Assessment
OTHER
Questionnaire Administration
OTHER
Telephone-Based Intervention
BEHAVIORAL
Lead Sponsor
Stanford University
NCT05039801
NCT04704661
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