Health and Recovery Program in Increasing Physical Activity Level in Stage IA-IIIA Endometrial Cancer Survivors

Cancer Survivor Clinical Trial

Official title:

Step Into Wellness: A Program of Health and Recovery for Endometrial Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03367923
• Other study ID #: IRB-43094
• Secondary ID: NCI-2017-02149GY
• Status: Completed
• Phase: Phase 2
• Start date: December 1, 2017
• Est. completion date: March 25, 2020

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 physical activity in endometrial cancer survivors and promote and maintain behavior change at a lower cost.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 25, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Survivor
• Endometrial Carcinoma
• Endometrial Neoplasms
• 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
• Stage IIIA Uterine Corpus Cancer AJCC v7

Intervention

Other:
• Communication Intervention
Receive email/text
• Counseling
Undergo exercise counseling
• Fitbit tracker
Wear Fitbit tracker
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Behavioral:
• Telephone-Based Intervention
Receive phone call

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Palo Alto	California
United States	Stanford Cancer Center South Bay	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to week 20-28
Secondary	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.	Up to 9 months
Secondary	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.	Up to 9 months
Secondary	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.	Up to 9 months
Secondary	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.	Up to 9 months
Secondary	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.	Up to week 20-28
Secondary	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.	Up to 9 months
Secondary	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	Up to 9 months