FitEx for Endometrial Cancer Survivors: Initial Efficacy

Carilion Clinic

Status: Active, not recruiting

Conditions: Endometrial Cancer; Quality of Life; Survivorship; Obesity; Sedentary Behavior

Treatments: Behavioral: Newsletters- Yoga; Behavioral: Weekly virtual sessions- Yoga; Behavioral: Newsletters- Standard; Behavioral: Self-monitoring; Behavioral: Weekly virtual sessions- Standard; Behavioral: Group-dynamics

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05737745

UL1TR003015 (U.S. NIH Grant/Contract)

IRB-22-1727

Details and patient eligibility

About

The goal of this clinical trial is to compare physical activity outcomes between endometrial cancer survivors randomized to 1 of 3 conditions: 1) usual care, 2) FitEx, 3) FitEx+yoga. Survivors randomized to FitEx groups will recruit ~3 support team members to complete the intervention with them. The main question[s] it aims to answer are:

• Do FitEx groups undertake more physical activity than the usual care group?
• Are there differences in quality of life, self-compassion, flourishing, self-efficacy, social support, habit formation, and fruit /vegetable consumption

Participants will:

• Wear a Fitbit
• Complete surveys
• Participate in 30 minute weekly virtual meetings (FitEx groups only)
• Receive weekly newsletters (FitEx groups only)

Full description

The purpose of this pilot study is to evaluate the initial efficacy of FitEx, a physical activity tracking and promotion program, and FitEx+yoga for endometrial cancer survivors (ECS), with focus on improvement of moderate-vigorous physical activity (MVPA) at the completion of the 8-week program. Specifically, this project will recruit early stage ECS with obesity to be randomized to 1 of 3 conditions: 1) usual care, 2) FitEx, 3) FitEx+yoga. ECS in either intervention condition will each select ~3 friends or family members to be their support members (minimum 2 and maximum 5). All ECS will receive a Fitbit to track their MVPA. We will then compare secondary ECS outcome measures between intervention and control groups including quality of life, self-compassion, flourishing, self-efficacy, social support, habit formation and fruit/vegetable consumption. Additionally, support team member MVPA (via Fitbit) and secondary outcomes will be compared. We will also explore long-term MPVA and secondary outcomes in all groups at 6 months.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

SURIVIVOR

• Diagnosed with early stage (I-II) endometrial cancer, any histology
• Received cancer care at Carilion Clinic after 1/1/2010
• At least 18 years of age
• Have adequate comprehension (reading and writing) of the English language
• Have a BMI ≥ 30 kg/m^2 at screening
• Have stable internet access or access to a smartphone with internet capabilities
• Meet the requirements of the Physical Activity Readiness Questionnaire(PARQ)
• Have the capacity to provide informed consent and are willing to provide informed consent
• SUPPORT TEAM--
• Were identified by a participant with endometrial cancer as a member of their support system
• Are at least 18 years of age
• Have adequate comprehension (reading and writing) of the English language
• Have stable internet access or access to a smartphone with internet capabilities
• Meet the requirements of the Physical Activity Readiness Questionnaire (PARQ)
• Have the capacity to provide informed consent and are willing to provide informed consent

Exclusion criteria

SURVIVOR

• Recurrent endometrial cancer
• Meeting physical activity guidelines set forth by the American Cancer Society at screening (greater than 150 minutes/week of moderate physical activity, or greater than 75 minutes/week of vigorous physical activity)
• SUPPORT TEAM: Have functional limitations requiring a walker, wheelchair, scooter, or other walking aid which limits their capacity to engage in the intervention safely

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Usual care

No Intervention group

Description:

Endometrial cancer survivors will receive standard survivorship care including a one-time educational newsletter about survivorship physical activity and nutrition recommendations. Fitbits will be given to track physical activity.

FitEx-ECS

Experimental group

Description:

Endometrial cancer survivors and their support team members (as a group of one survivor and their team) will complete the FitEx-ECS intervention program, with a focus on walking. Fitbits will be given to track physical activity.

Treatment:

Behavioral: Group-dynamics

Behavioral: Weekly virtual sessions- Standard

Behavioral: Newsletters- Standard

Behavioral: Self-monitoring

FitEx-ECS+ Yoga

Experimental group

Description:

Endometrial cancer survivors and their support team members (as a group of one survivor and their team) will complete the FitEx-ECS+yoga intervention program, with a focus on postures, breathwork, and mindfulness. Fitbits will be given to track physical activity.

Treatment:

Behavioral: Group-dynamics

Behavioral: Self-monitoring

Behavioral: Weekly virtual sessions- Yoga

Behavioral: Newsletters- Yoga