The Feasibly, Efficacy, and Acceptability of FitEx for Endometrial Cancer Survivors: A Pilot Randomized Controlled Trial of Walking With or Without Yoga
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility and Acceptability as measured by recruitment rate and program completion
研究概览
简要总结
The purpose of this study is to determine whether a physical activity tracking program called FitEx would be useful to endometrial cancer survivors. Each interested endometrial cancer survivor will recruit 1 to 5 additional friends/family members to participate in the intervention with them, forming a team.
Each team will be randomized to FitExEC (control group) that receives FitEx for endometrial cancer survivors, or FitExEC+yoga (experimental group) that receives FitEx for endometrial cancer survivors plus yoga cueing. FitExEC is based on FitEx, a program used to encourage adults to improve their fruit and vegetable intake while increasing their physical activity. FitEx works by having participants join a team with their friends and loved ones, so they can support one another in meeting their goals. In this study, teams of endometrial cancer survivors/support members will receive watches that track how much they walk.
Each day, participants record how much exercise, how many fruits, and how many vegetables they've eaten that day for a total of 8 weeks. Participants will be encouraged to attend a virtual session 15 minutes per week that will focus on 1-mile worth of exercise points (all control) or 15 minutes of yoga (all experimental) followed by 15 minutes of support (endometrial cancer survivors only [control and experimental survivors in different groups]).
Participation in the study lasts roughly 10 weeks, and participants will be followed for 6 months afterward. The investigators think that FitEx may help people with endometrial cancer improve their daily physical activity and slowly improve their health and quality of life. The investigators hypothesize this intervention is feasible and acceptable to Carilion Clinic endometrial cancer survivors.
详细描述
Uterine cancer is the leading form of gynecologic malignancy in the United States. Currently, there are more than 600,000 EC survivors in the United States, and that number is expected to grow. Endometrial cancer (EC) is caused by excess estrogen, which acts as an oncogenic signal. Postmenopausal women with obesity have increased production of estrogen and are at an increased risk of developing type I EC.
Endometrial cancer was one of the first types of cancer to have an established relationship with body mass index (BMI). This relationship is linear and dose-dependent with BMI and can be explained by excess estrogen production . In women, adipose tissue is able to generate a form of estrogen known as estrone. Excess adipose tissue leads to increased production of estrone, which proliferates endometrial growth. For every five unit increase of BMI, the production of excess estrogen drives a 50% increased relative risk of developing EC.
Approximately 62% of American women are overweight or obese, putting them at increased risk of developing EC, the sixth most common cancer type in women in the United States. As the obesity rate in America continues to rise, the incidence of EC cases follows similar patterns. Between 2003 to 2015, the number of new EC diagnoses has increased by 13%, and continues to increase by 1% in following years. The National Cancer Institute predicts that nearly 60,000 new cases of EC will be diagnosed in 2021 and estimates that nearly 3% of women will be diagnosed with EC in their lifetime.
Fortunately, EC patients have relatively strong outcomes compared to other cancer types, as patients have an approximately 80% 5-year survival rate. However, a vast majority (70 - 90%) of type 1 EC survivors are obese. Five years after diagnosis, women with EC are more likely to die from cardiovascular disease and its risk factors, such as obesity and type 2 diabetes, than from EC. EC survivors with obesity report higher rates of depression and lower quality of life outcomes (sleep quality, self-esteem, fatigue, daily stress, etc.) than their non-obese counterparts. These outcomes worsen as BMI increases.
Addressing the role of obesity in EC survivors by encouraging physical activity is critical to improving optimal longitudinal care to survivors suffering from declining quality of life. Regular physical activity is associated with decreased levels of circulating estrogens in post-menopausal women and moderate physical activity in adulthood has been associated with reduced rates of developing endometrial cancer. As measured by a meta-analysis of physical activity interventions in participants with cancer, physical activity has established improvements to quality of life, fatigue, and physical functioning.
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
- 是
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
- •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
- •History of recurrent endometrial cancer TARGET - Vital status: deceased
- •Are 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)
- •Have functional limitations requiring a walker, wheelchair, scooter, or other walking aid which limits their capacity to engage in the intervention safely
- •Healthy volunteers can be either gender with criteria below:
- •Inclusion Criteria:
- •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:
- •Have functional limitations requiring a walker, wheelchair, scooter, or 6 other walking aid which limits their capacity to engage in the intervention safely
结局指标
主要结局
Feasibility and Acceptability as measured by recruitment rate and program completion
时间窗: 8 weeks
Our primary aims are program adherence, measured as the percentage of participants who complete the 8 week program, and recruitment rate, measured as the percentage of participants who join the study out of the total participants who are approached about the study. These outcomes will be used to assess the feasibility and acceptability of the study among participants who enroll in the study and percentage of participants who complete the program.
次要结局
- Changes to Yoga Self-Efficacy as measured by Yoga Self Efficacy questionnaire(6 months)
- Changes to self-reported physical activity levels as measured by L-Cat questionnaire(6 months)
- Changes to Quality of Life as measured by FACT-En questionnaire(6 months)
- Self reported physical activity measured via steps per day on pedometer(6 months)
- Changes to Fear of Cancer Recurrence measured by Fear of Cancer Recurrence Inventory questionnaire(6 months)