Feasibility and Effectiveness of an Innovative Exercise Program to Reduce Fatigue in Rural Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at 12 weeks
研究概览
简要总结
The objective of this investigation is to establish the feasibility and initial effectiveness of a novel exercise program for rural cancer survivors in Colorado suffering from cancer related fatigue. Participation in an exercise program has regularly been shown to reduce fatigue in cancer survivors, though in-person, supervised participation has a greater effect on fatigue than home-based programs with no supervision. Access to these supervised programs are limited in rural areas, restricting the ability of rural cancer survivors to experience the fatigue-reducing benefits of exercise. The proposed program will use information on improvements in fatigue from participants in the BfitBwell Cancer Exercise Program to monitor improvements in fatigue in rural cancer survivors performing a home exercise program and trigger a telehealth session with a cancer exercise specialist to adapt the exercise prescription when improvements are less than expected. The BfitBwell Program is an established exercise program at the Anschutz Health and Wellness Center which has worked with over 600 cancer survivors and is highly effective at reducing cancer related fatigue. The goal of the program is to replicate the effects of a successful supervised exercise program in rural cancer survivors who do not have access to this type of program. This investigation will recruit 20 rural cancer survivors experiencing fatigue and assess their ability to participate in the program, as well as how well the program improves their fatigue. Interviews will be conducted with participants after the program to determine how future versions of the program could be improved. The investigators anticipate that this program will be feasible and effective, providing preliminary data to pursue a large-scale clinical trial of the program following this project's completion.
详细描述
The proposed exercise program utilizes a novel reference chart system to monitor cancer-related fatigue (CRF) and trigger necessary interventions. This reference chart has been developed from CRF data collected in 173 cancer survivors participating in the BfitBwell Program, a highly effective supervised exercise program pioneered at the University of Colorado. The reference chart estimates the continuous trajectory of fatigue improvement during the three-month program. The focus of this study is to extend the benefits of an effective, supervised exercise program to rural Coloradoans via a home exercise program supported by CRF monitoring and symptom-triggered telehealth sessions. Deviations from estimated improvements in CRF will trigger telehealth sessions with a cancer exercise specialist (CES) to adapt the exercise prescription, in real time, as in a supervised program. The intent is to replicate the effects of a supervised exercise program in cancer survivors in rural areas without access to such programs. The feasibility, effectiveness, and design of the program will be assessed with two specific aims.
Aim 1: Determine the feasibility and preliminary effectiveness of the proposed exercise program.
Objective 1a: Assess the enrollment rate of patients able and willing to participate in the program and the adherence of patients enrolled in the program to their prescribed exercise, CRF monitoring, and telehealth session participation.
Objective 1b: Assess the effect of the proposed program on CRF improvements in enrolled participants and compare this effect to that of the supervised BfitBwell exercise program.
Exploratory Objective 1: Assess the feasibility of the semi-continuous remote monitoring of fatigue (ecological momentary assessment) to better tailor the program to more acute changes in CRF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (>= 18 years) cancer survivor.
- •A maximum age of 80 will be set as virtual exercise may become unsafe as individuals get older.
- •A cancer diagnosis of any type
- •CRF is a common symptom across cancer types and the current CRF reference chart was developed using data from patients with all cancer types.
- •Current report of moderate-to-severe fatigue (> 3 on a 0-10 scale, per NCCN definition31)
- •Live in rural Colorado and surrounding areas (> 1-hour commute to major front range city [Denver, Fort Collins, and Colorado Springs])
- •This program attempts to target individuals in Colorado and surrounding areas with restricted access to fitness centers that may offer cancer specific services, most likely found in major front range cities. We have defined rural in terms of commute time to these cities, as it is the commute to these centers that restricts access.
- •Completed medical cancer treatment (chemotherapy and/or radiation) with curative intent within past 12 months or currently on treatment with no planned changes for the next 4 months (e.g. maintenance or palliative therapy).
- •No additional treatment planned for next 4 months.
- •These restrictions are made to ensure the validity of tracking changes with the established reference chart, which was developed using data from cancer survivors who had recently completed therapy or were on therapy
- •It is unclear how fatigue response to exercise may change in survivors further out from treatment completion.
- •High-speed home internet and smartphone (or laptop with camera).
排除标准
- •- Medical conditions that would impact the safety of, or participation in, an exercise program. This includes:
- •Orthopedic conditions such as advanced osteoarthritis, mobility-limiting amputations or chronic injuries, or mobility- limiting acute orthopedic injuries
- •Advanced rheumatoid arthritis
- •Widespread chronic pain conditions such as fibromyalgia
- •Significant balance impairment increasing the risk of falling
- •Pulmonary conditions such as chronic obstructive pulmonary disease, emphysema, interstitial lung disease, use of supplemental oxygen
- •Known cardiovascular disease, uncontrolled hypertension, or new cardiac event within the past 6 months.
研究组 & 干预措施
Virtual exercise program
This arm will receive the virtual exercise program.
干预措施: Exercise (Behavioral)
结局指标
主要结局
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at 12 weeks
时间窗: Baseline (week 0), 12 weeks
13-item instrument widely used to assess cancer related fatigue. Score range: 0-52. Lower scores indicate more fatigue.
次要结局
- Changes in Hospital Anxiety and Depression Scale (HADS) at 15 months(Baseline (week 0), 15 months)
- Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at 6 months(Baseline (week 0), 6 months)
- Changes Tecumseh Step Test(Baseline (week 0), 12 weeks)
- Change in Godin Leisure-Time Physical Activity Questionnaire (GLTPAQ) at 9 months(Baseline (week 0), 9 months)
- Changes in Functional Assessment of Cancer Therapy-General form (FACT-G) at 6 month(Baseline (week 0), 6 months)
- Changes in Multidimensional Fatigue Inventory (MFI) at 15 months(Baseline (week 0), 15 months)
- Changes in Hospital Anxiety and Depression Scale (HADS) at 6 months(Baseline (week 0), 6 months)
- Change in Godin Leisure-Time Physical Activity Questionnaire (GLTPAQ) at 6 months(Baseline (week 0), 6 months)
- Changes in Multidimensional Fatigue Inventory (MFI) at 6 months(Baseline (week 0), 6 months)
- Change in Godin Leisure-Time Physical Activity Questionnaire (GLTPAQ) at 12 weeks(Baseline (week 0), 12 weeks)
- Changes in Steps per day(Baseline (week 0), 12 weeks)
- Changes in Hospital Anxiety and Depression Scale (HADS) at 12 weeks(Baseline (week 0), 12 weeks)
- Changes in Single limb stance(Baseline (week 0), 12 weeks)
- Changes in Gait speed(Baseline (week 0), 12 weeks)
- Changes in Timed up and go(Baseline (week 0), 12 weeks)
- Changes in 30 s Sit-to-Stand(Baseline (week 0), 12 weeks)
- Change in Godin Leisure-Time Physical Activity Questionnaire (GLTPAQ) at 15 months(Baseline (week 0), 15 months)
- Changes in Average sleep time(Baseline (week 0), 12 weeks)
- Changes in Functional Assessment of Cancer Therapy-General form (FACT-G) at 12 weeks(Baseline (week 0), 12 weeks)
- Changes in Functional Assessment of Cancer Therapy-General form (FACT-G) at 9 months(Baseline (week 0), 9 months)
- Changes in Functional Assessment of Cancer Therapy-General form (FACT-G) at 15 months(Baseline (week 0), 15 months)
- Changes in Multidimensional Fatigue Inventory (MFI) at 12 weeks(Baseline (week 0), 12 weeks)
- Changes in Multidimensional Fatigue Inventory (MFI) at 9 months(Baseline (week 0), 9 months)
- Changes in Hospital Anxiety and Depression Scale (HADS) at 9 months(Baseline (week 0), 9 months)
- Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at 9 months(Baseline (week 0), 9 months)
- Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at 15 months(Baseline (week 0), 15 months)