Effects of a Telehealth Exercise Program for Rural Cancer Survivors With Cancer-related Fatigue Including Integrated Longitudinal Assessments of Objective Physical Function and Fatty Acid Oxidation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Change from Baseline in FACIT-Fatigue (cancer-related fatigue) score at Week 12
研究概览
简要总结
This study investigates the efficacy of a telehealth exercise program designed specifically for rural cancer survivors with cancer-related fatigue (CRF). Small dried blood samples and measures of physical function will be collected throughout the program. The main questions it aims to answer are:
- Does the exercise program improve CRF in rural cancer survivors?
- How do CRF, metabolism, and physical function change during the exercise program? Researchers will compare the program to a wait-list control group. This group will complete all study measures without without changing current physical activity before receiving the full exercise program.
Participants will:
- Complete a virtual physical assessment before and after the program.
- Complete brief virtual assessments and collect dried blood samples (at home and mailed in) every two weeks during the program.
- Receive a personalized exercise program including virtual sessions and remote exercise programming with a cancer exercise specialist (after a 12-week wait period in the wait-list control group).
- Optional: Willing participants will visit a study site for a laboratory-based exercise assessment before and after the program.
详细描述
This study investigates the efficacy of a telehealth exercise program designed specifically for rural cancer survivors with cancer-related fatigue (CRF). The 12-week program is designed to be delivered completely via remote methods including: telehealth exercise sessions with cancer exercise specialists, additional exercise programming delivered through a personal training smartphone/internet application, and regular symptom monitoring via emailed surveys. Symptoms (CRF) are plotted against a reference chart of anticipated changes during the program, with additional telehealth sessions initiated if symptoms do not improve as predicted. Program efficacy is investigated using a randomized controlled trial with a wait-list control group (N=134, Aim 1). The control group will receive the exercise program following a 12-week wait period.
Possible mechanisms of action are assessed throughout the program (every two weeks) using accessible methods (Aim 2). Fatty acid oxidation is measured via dried blood spots collected remoted and mailed to the primary study site. Physical function is measured via brief telehealth assessments.
Changes in molecular responses to acute exercise and changes in body composition will be explored in a controlled laboratory assessment in participants able and willing to travel to participating sites (N=40, Aim 3). Small blood samples are collected before and after a standardized treadmill exercise session. Body composition is measured non-invasively in a small chamber using air displacement. This laboratory assessment occurs before and after the program (or wait period).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Age ≥ 18 and < 90 years of age.
- •Diagnosis of breast or prostate cancer.
- •Cancer treatment criteria: 3a. Completion of treatment with curative intent > 3 months prior to and < 5 years from study initiation.
- •3b. Treatment must include hormonal, radiation, chemotherapy, and/or immunotherapy. Those who have received only surgery are not eligible.
- •3c. Individuals diagnosed with breast cancer currently receiving maintenance hormonal therapy, with no planned treatment changes in the next six months, are eligible.
- •4. Home zip code meeting Health Resources & Services Administration (HRSA) definition of rural (data.hrsa.gov/tools/rural-health).
- •5. Presence of at least moderate fatigue (>3/10 per National Comprehensive Cancer Network guidelines).
- •6. Access to high-speed home internet.
- •Possession of smartphone or laptop with front-facing camera.
- •Capable and willing to give informed consent.
- •Willing to participate in a 12-week telehealth exercise intervention or 12-week waiting period prior to intervention with brief remote physical assessments and dried blood spot collection every 2 weeks.
- •10. Able and willing to provide contact information for a local support individual to assist with any possible adverse events.
- •11. Able and willing to provide contact information for a local primary care provider to address medical issues potentially arising during study activities.
- •12. Able to provide signed physician clearance for exercise if indicated by the Physical Activity Readiness Questionnaire (PAR-Q+) or National Comprehensive Cancer Network exercise safety screening questions.
排除标准
- •Eastern Cooperative Oncology Group (ECOG) Performance Status Grade ≥
- •Current or planned cancer-related treatments (except maintenance hormonal therapies) in the next six months.
- •2a. For individuals with a prostate cancer diagnosis, those currently receiving androgen deprivation therapy (ADT), or those who have previously received ≥ 12 months of ADT, are not eligible.
- •3. Plans to relocate to a non-rural location in the next six months.
- •Presence of a disease or condition that affects the ability of an individual to safely participate in an exercise intervention (e.g. recent cardiac event or chronic obstructive pulmonary disease).
- •4a. These conditions are identified in the PAR-Q+.
- •Presence or history of metabolic disease (e.g. diabetes or uncontrolled hyper- or hypothyroidism).
- •5a. Participants with pre-diabetes, metabolic syndrome, or diabetes managed with metformin only will be eligible, with this variable tracked for later analysis.
- •6. Current participation in another exercise oncology program.
研究组 & 干预措施
Telehealth Exercise Program
The BfitBwell-TP (Telehealth Program) intervention is designed specifically for rural cancer survivors with cancer-related fatigue (CRF). It is personalized to each participant, addresses known barriers to exercise participation in rural survivors, and incorporates the experience and infrastructure of the established clinical BfitBwell Cancer Exercise Program. BfitBwell-TP is delivered completely via existing and accessible telehealth technologies including: videoconference sessions with a cancer exercise specialist, exercise programming and text communication using a personal training smartphone/internet application, and emailed surveys. CRF is assessed throughout the program with additional telehealth sessions initiated if it does not improve as predicted based on a reference chart developed with BfitBwell data.
干预措施: Telehealth Exercise Program (Behavioral)
Waitlist Control Group
This group will be instructed to not change their current physical activity and exercise routines while completing all study assessments (including brief assessments every two weeks). After completing a final assessment following the 12-week wait period, they will receive the full exercise intervention (see Experimental Arm for description).
结局指标
主要结局
Change from Baseline in FACIT-Fatigue (cancer-related fatigue) score at Week 12
时间窗: Baseline, Week 12
The Functional Assessment of Chronic Illness Therapy - Fatigue scale (FACIT-Fatigue) is a common standardized measure of cancer-related fatigue. It contains 13 items with total score ranging from 0 to 52, with higher scores indicating less fatigue.
次要结局
- Change from Baseline in FACIT-Fatigue (cancer-related fatigue) score at Week 24(Baseline, Week 24)
- Change from Baseline in FACT-G (quality of life) score at Week 12(Baseline, Week 12)
- Pattern of change in FACIT-Fatigue (cancer-related fatigue) score during exercise intervention or wait period(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
- Change from Baseline in FACT-G (quality of life) score at Week 24(Baseline, Week 24)
- Change from Baseline in HADS (anxiety and depression) scores at Week 12(Baseline, Week 12)
- Change from Baseline in HADS (anxiety and depression) scores at Week 24(Baseline, Week 24)
- Change from Baseline in EORTC QLQ-FA12 (cancer-related fatigue) scores at Week 12(Baseline, Week 12)
- Change from Baseline in EORTC QLQ-FA12 (cancer-related fatigue) scores at Week 24(Baseline, Week 24)
- Change from Baseline in 2MST (physical function) at Week 12(Baseline, Week 12)
- Change from Baseline in CS (physical function) at Week 12(Baseline, Week 12)
- Change from Baseline in GS (physical function) at Week 12(Baseline, Week 12)
- Change from Baseline in TUG (physical function) at Week 12(Baseline, Week 12)
- Change from Baseline in SLB (physical function) at Week 12(Baseline, Week 12)
- Change from Baseline in daily physical activity (PA) at Week 12(Baseline, Week 12)
- Change from Baseline in average sleep time at Week 12(Baseline, Week 12)
- Change from Baseline in fatty acid oxidation at Week 12(Baseline, Week 12)
- Change from Baseline in dynamic exercise metabolic profiles at Week 12(Baseline, Week 12)
- Change from Baseline in body composition at Week 12(Baseline, Week 12)
- Pattern of change in FACT-G (quality of life) score during exercise intervention or wait period(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
- Pattern of change in HADS (anxiety and depression) scores during exercise intervention or wait period(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
- Pattern of change in EORTC QLQ-FA12 (cancer-related fatigue) scores during exercise intervention or wait period(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
- Pattern of change in 2MST (physical function) during exercise intervention or wait period(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
- Pattern of change in CS (physical function) during exercise intervention or wait period(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
- Pattern of change in GS (physical function) during exercise intervention or wait period(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
- Pattern of change in TUG (physical function) during exercise intervention or wait period(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
- Pattern of change in SLB (physical function) during exercise intervention or wait period(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
- Pattern of change in fatty acid oxidation during exercise intervention or wait period(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)