ACTIVATE: A Pilot Randomized Activity Coaching Trial to Increase Vitality and Energy During Post-operative Pelvic Radiation Therapy for Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 8
- 主要终点
- Feasibility of a Randomized Trial: Participant Adherence to Exercise Coaching Sessions
研究概览
简要总结
Research has shown that for women who are undergoing pelvic radiation therapy, fatigue is a common side effect. Fatigue that occurs during radiation therapy can make it harder to perform daily living activities. While there are studies that recommend exercise as a treatment for fatigue in cancer patients and survivors, there are currently no studies that focus on the role of exercise for women undergoing pelvic radiation therapy. The purpose of this study is to see if incorporating an activity coaching program is helpful in improving treatment-related fatigue for women undergoing pelvic radiation therapy for endometrial cancer.
详细描述
The exercise coaching program is a program in which Participants will have ten weekly check-ins with a certified exercise coach. During check-ins, Participants and the exercise coach will set weekly goals. Participants will try to incorporate activities that are easy and enjoyable for them. These visits can be scheduled at their convenience and choose whether these check-ins will be in-person, or virtually.
All Participants who agree to join this study will be asked to:
- Participate in a program with an exercise coach to set weekly goals for activity. The timing of when the program will start will be based on the group Participants are assigned to.
- Receive a Fitbit to track how active they are, their heart rate and how many steps they've have taken.
- Complete 4 surveys which will be given throughout the course of the study.
- Complete a short 6-minute walking test to see how their heart and lungs respond to exercise. This test will be completed 4 times throughout the study.
- Participate in an interview with the principal investigator at the end of the study for feedback on how the study can be improved.
The study team expects to enroll 16 patients in this study. Participants will either be placed in the Immediate Start Activity Coaching Program or the Delayed Start Activity Coaching Program. 8 patients will be assigned to the Immediate Start Group, and 8 will be assigned to the Delayed Start Group. Participants will spend about 6 months in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Pathologic diagnosis of endometrial cancer (any histology, Stage I-IVA)
- •Has undergone modified radical or radical hysterectomy
- •Plan to receive adjuvant treatment with pelvic external beam radiation therapy at ISCI
- •ECOG performance status of 0-1
- •Patient has a computer, smart phone, or tablet virtual access to the web-based platform and email
- •Able to read, understand and provide written informed consent
- •Deemed appropriate for unmonitored exercise by treating physician based on the following evidence-based criteria (1)
- •Walk without any assistance or assistance device
- •Absence of significant cognitive impairment
- •Absence of high risk for falls
- •Participant does not need to refrain from any activity
排除标准
- •Unable to schedule and attend coaching visits
- •Participation in a regular exercise program of ≥150 minutes of moderate intensity exercise a week at baseline
- •Unable to perform the five-times stand test
- •Medical comorbidities including:
- •Unstable angina
- •Uncontrolled dysrhythmias
- •Acute pulmonary embolus
- •Active pulmonary infection
研究组 & 干预措施
Delayed Start Group
Participants in this group will start 6-8 weeks post - radiation and continue 16-19 weeks post-radiation.
干预措施: Exercise Coaching (Behavioral)
Immediate Start Group
Participants in this group will start the intervention during the first week of radiation therapy and continue through and post-completion of radiation
干预措施: Exercise Coaching (Behavioral)
结局指标
主要结局
Feasibility of a Randomized Trial: Participant Adherence to Exercise Coaching Sessions
时间窗: Enrollment to end of follow up, up to 24 months
Participant adherence to coaching sessions will be defined as complete adherence when engaging in 10 of the 10 planned exercise coaching sessions and high adherence as engaging in at least 7 of the planned 10 exercise coach check-ins. Participant adherence will be considered feasible if 70% of participants adhere to the coaching sessions.
次要结局
- Change in patient-reported bowel/urinary toxicity(Enrollment to end of follow up, up to 24 months)
- Change in patient-reported fatigue(Enrollment to end of follow up, up to 24 months)
- Change in patient-reported Quality of Life (QOL)(Enrollment to end of follow up, up to 24 months)
- Change in patient-reported cognitive function(Enrollment to end of follow up, up to 24 months)
- Change in patient-reported sexual function and satisfaction(Enrollment to end of follow up, up to 24 months)
- Change in patient-reported self-efficacy(Enrollment to end of follow up, up to 24 months)
- Change in distance walked during the 6-Minute Walk Test (6MWT)(Enrollment to end of follow up, up to 24 months)