Online Cancer-Related Fatigue Management
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in Fatiue Level: Brief Fatigue Inventory
研究概览
简要总结
Many individuals who have had cancer experience functional limitations during and after their treatments. The most common side effect from cancer treatment that restricts cancer survivors' completion of daily activities is cancer-related fatigue. Here, we propose to investigate whether an interprofessional approach that targets physiologic, psychologic, and ecological factors will minimize cancer-related fatigue and enhance daily life participation for volunteer cancer survivors living in the community. The interprofessional team will include occupational therapy professor and students from Eastern Kentucky University (EKU), physical therapy and dietitian professors and their students from the University of Dayton, and instructional design instructor from EKU. The approach will include (1) individualized exercise programs-via physical therapy; (2) problem-solving strategies including modifying the environment or activity -via occupational therapy; (3) goal development via physical and occupational therapy; and (4) cancer-related fatigue education via instructional design. We hypothesize that this approach will result in participants experiencing less fatigue, increasing their mobility, improving their quality of life, and being more satisfied with how they perform daily activities.
详细描述
Setting: Virtual environment
- Evaluation and weekly meetings will be provided through Zoom® conferencing system provided by EKU or University of Dayton.
- Educational and Exercise Videos will be accessed within an individual webpage for each participant within the study's website.
Research Design Pre-test/Post-test quasi-experimental design without a control group. This research design will allow us to assess if there is a change in the level of fatigue, mobility, quality of life, and/or perceived performance and satisfaction of important activities Screening Individuals who are interested in participating will contact the Occupational Therapy professor--principal investigator (PI) or Physical Therapy professor-collaborator (CL). PI or CL will contact the potential participant either by telephone or email. Within this initial communication, the potential participant will be provided with the following information: time commitment, type of evaluations, and intervention. If the participant continues to be interested, an electronic inclusion criteria screen will be sent. If all inclusion criteria are met, PI or CL will ask the participant for their physician contact information so a medical release form can be sent to them.
Physician medical release A release form will be faxed, sent electronically, or mailed to participant's oncology or primary care provider. Once this signed release is received, we will send an electronic version of the informed consent to the potential participant and schedule a time to review it and a tentative time for the initial evaluation.
Initial, Weekly, 4-week, and 8-week Standard of Care Cancer Survivor Evaluations Initial Evaluations After the participant agrees to take part in the study and signs the informed consent, the initial evaluation including questionnaires and physical therapy and occupational therapy assessments within one to two visits will be administered by physical therapy and occupational therapy students (PTSI and OTSI). Assessments will be recorded and reviewed by the supervising therapy professor to ensure assessments are performed using standardized methods. After the assessment eight weekly meetings will be schedule.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Completed treatment for a cancer diagnosis within 5 years of enrollment
- •Access to mobile device or computer
- •Basic computer or mobile device skills
- •Experience a significant level of fatigue defined as >= 4 on 0-10 scale using the One-item Fatigue Scale.
排除标准
- •Currently undergoing chemotherapy or radiation treatment
- •Unwilling to participate in an exercise program
- •Have metastatic cancer (Stage 4)
- •Do not have physician consent to participate in the exercise program
- •Unable to follow verbal or written assessment instructions
- •Non-English speaking.
结局指标
主要结局
Change in Fatiue Level: Brief Fatigue Inventory
时间窗: Change from 4 week measure at 8 weeks
This 9-item scale assesses the severity and interference of fatigue on a 0 (no fatigue) to 10 (greatest fatigue) scale
Perceived Functional Change: Canadian Occupational Performance Measure
时间窗: Change from 4 week measure at 8 weeks
a semi-structured interview to understand the routine activities that the participant completes daily, specifically their self-care, leisure, and social activities. The participant rates the importance of each of the activities using a 0 to 10 scale. Zero indicates "no importance" and 10 indicates "very important." Then the participant rates their perception of how well they currently perform each of the important activities and how satisfied they are with their performance using a 0 to 10 scale. Zero indicates that "they are not able to perform" or "they are not satisfied" and 10 indicates that "they are able to perform the activity well" or "they are very satisfied." This is repeated for how satisficed with how they currently perform each important activity.
次要结局
- FACIT-Fatigue(Change from Baseline measure at 8 weeks)
- One Item Fatigue Scale(Change from baseline measure at 8 weeks)
- 6-minute walk test(Change from 4 week measure at 8 weeks)
- 30-second Sit to Stand(Change from 4 week measure at 8 weeks)
- Borg Perceived Exertion 6-20 scale(Change from 4 week measure to 8 weeks)
研究者
ANNE FLEISCHER
Professor
Eastern Kentucky University