The Initial Efficacy of FitEx for Endometrial Cancer Survivors: A Pilot Randomized Controlled Trial of a Walking Promotion Program With or Without Yoga
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Usual care
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
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.
干预措施: Group-dynamics (Behavioral)
FitEx-ECS
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.
干预措施: Self-monitoring (Behavioral)
FitEx-ECS
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.
干预措施: Weekly virtual sessions- Standard (Behavioral)
FitEx-ECS
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.
干预措施: Newsletters- Standard (Behavioral)
FitEx-ECS+ Yoga
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.
干预措施: Self-monitoring (Behavioral)
FitEx-ECS+ Yoga
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.
干预措施: Group-dynamics (Behavioral)
FitEx-ECS+ Yoga
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.
干预措施: Newsletters- Yoga (Behavioral)
FitEx-ECS+ Yoga
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.
干预措施: Weekly virtual sessions- Yoga (Behavioral)
结局指标
主要结局
Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors
时间窗: Change from baseline to 8 weeks (post-intervention)
Among survivors, compare changes in objective moderate-vigorous physical activity (MVPA) obtained from FitBits (continuous tracking) between intervention groups and usual care (FitEx-ECS vs. control and FitEx-ECS+yoga vs. control)
次要结局
- Physical Activity Level (Active or Insufficiently Active)- Survivors(Change from baseline to 8 weeks (post-intervention))
- Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors- Maintenance(Change from 8 weeks to 6 months (post-intervention))
- Quality of Life- Survivors(Change from baseline to 8 weeks (post-intervention))
- Quality of Life Maintenance- Survivors(Change from 8 weeks to 6 months (post-intervention))
- Servings of Daily Fruits and Vegetables Maintenance- Survivors(Change from 8 weeks to 6 months (post-intervention))
- Servings of Daily Fruits and Vegetables- Survivors(Change from baseline to 8 weeks (post-intervention))
- Flourishing- Survivors(Change from baseline to 8 weeks (post-intervention))
- Flourishing Maintenance- Survivors(Change from 8 weeks to 6 months (post-intervention))
- Yoga Self-Efficacy- Survivors(Change from baseline to 8 weeks (post-intervention))
- Yoga Self-Efficacy Maintenance- Survivors(Change from 8 weeks to 6 months (post-intervention))
- Social Support- Survivors(Change from baseline to 8 weeks (post-intervention))
- Social Support Maintenance- Survivors(Change from 8 weeks to 6 months (post-intervention))
- Self-compassion- Survivors(Change from baseline to 8 weeks (post-intervention))
- Self-compassion Maintenance- Survivors(Change from 8 weeks to 6 months (post-intervention))
- Habit Formation- Survivors(Change from baseline to 8 weeks (post-intervention))
- Habit Formation Maintenance- Survivors(Change from 8 weeks to 6 months (post-intervention))
- Physical Activity Level (Active or Insufficiently Active) Maintenance- Survivors(Change from 8 weeks to 6 months (post-intervention))
研究者
Shannon Armbruster
Principal Investigator
Carilion Clinic