Cancer Survivor, Endometrial Carcinoma, Stage IA Uterine Corpus Cancer AJCC v7, Stage IB Uterine Corpus Cancer AJCC v7, Stage IIIA Uterine Corpus Cancer AJCC v7, Stage II Uterine Corpus Cancer AJCC v7, Stage I Uterine Corpus Cancer AJCC v7
Conditions
Brief 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 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.
Interventions
OTHERCommunication Intervention
Receive email/text
OTHERCounseling
Undergo exercise counseling
OTHERFitbit tracker
Wear Fitbit tracker
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
BEHAVIORALTelephone-Based Intervention
Receive phone call
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase in activity level measured using Fitbit tracker | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulse | 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. |
| Blood pressure | 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. |
| Body mass index (BMI) | 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. |
| Rate of increased activity level measured using Fitbit tracker | 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. |
| Waist circumference | 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 |
| Quality of life assessment using Functional Assessment of Cancer Therapy-General (FACT-G) | 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. |
Countries
United States
Outcome results
None listed