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

Stanford University

Status and phase: Completed; Phase 2

Conditions: Endometrial Carcinoma; Stage I Uterine Corpus Cancer AJCC v7; Stage II Uterine Corpus Cancer AJCC v7; Cancer Survivor; Stage IB Uterine Corpus Cancer AJCC v7; Stage IA Uterine Corpus Cancer AJCC v7; Stage IIIA Uterine Corpus Cancer AJCC v7

Treatments: Behavioral: Telephone-Based Intervention; Other: Communication Intervention; Other: Quality-of-Life Assessment; Other: Counseling; Other: Questionnaire Administration; Other: Fitbit tracker

Study type: Interventional

Funder types: Other

Identifiers

NCT03367923

NCI-2017-02149 (Registry Identifier)

IRB-43094

GYNEND0002 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Arm I (exercise counseling, Fitbit, phone call)

Experimental group

Description:

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.

Treatment:

Behavioral: Telephone-Based Intervention

Other: Fitbit tracker

Other: Questionnaire Administration

Other: Counseling

Other: Quality-of-Life Assessment

Arm II (exercise counseling, Fitbit, email/text)

Experimental group

Description:

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.

Treatment:

Other: Fitbit tracker

Other: Questionnaire Administration

Other: Communication Intervention

Other: Counseling

Other: Quality-of-Life Assessment