Feasibility and Early Efficacy of the Maximizing Energy Intervention for Decreasing Fatigue Impact in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Participant Adherence to treatment: Receipt
研究概览
简要总结
This study is testing a program called Maximizing Energy to see if it can help women who have finished breast cancer treatment manage their fatigue. The study has two main goals:
- Check if the program can be successfully delivered - Researchers will see if women are willing to join and stay in the study, if they follow the program, and if they find it helpful.
- See if the program works - Researchers will compare Maximizing Energy to a general health education program to see which one helps reduce cancer-related fatigue better.
Participant will:
- Take tests to see if they qualify and to measure their fatigue.
- Be randomized to receive Maximizing Energy or Health Education Interventions for 6 sessions over the internet
- After the sessions and again one month later, repeat some tests to see if their fatigue has improved.
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
- Single (Outcomes Assessor)
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
- •adult (18 years and older) pre and post-menopausal female at birth diagnosed with Stages I-IIIa breast cancer,
- •completed primary treatment for breast cancer (surgery, chemotherapy, radiation) at least 6 months prior to ensure that fatigue is stable and chronic, - moderate to severe fatigue based on score ≥ 4 on the 7-point Fatigue Severity Scale,
- •able to speak and understand English
- •has a mobile device that runs on the Apple or Android platform
排除标准
- •major depressive disorder, mania, hypomania, psychosis, or substance abuse in the past 3 months and
- •disability due to diagnoses other than breast cancer.
研究组 & 干预措施
Maximizing Energy
Maximizing Energy
干预措施: Maximizing Energy Intervention (Behavioral)
Health Education
Health Education
干预措施: Health Education (Behavioral)
结局指标
主要结局
Participant Adherence to treatment: Receipt
时间窗: Week 7 (post-6-week intervention)
The investigators will collect data on the number of intervention sessions attended by participants
Retention in the study
时间窗: Baseline to Week 11 (4 weeks post-intervention)
The proportion of participants who remain in the study until its completion relative to those initially enrolled. The retention rate will be calculated separately for the Maximizing Energy and Control Groups using the following formula: (number of participants who completed the study/number of participants initially enrolled)X 100
Participant Adherence to treatment: Enactment
时间窗: Week 7(post-6-week intervention)
The investigators will collect interventionist rating of whether participant completed action plan from previous session (3-point scale; 0 = not completed, 2 = plan completed) for the MAX Intervention group only.
Participant Satisfaction with Intervention
时间窗: Week 7(post-6-week intervention)
Client satisfaction is measured using the Client Satisfaction Questionnaire. The Clients Satisfaction Questionnaire is an 8-item assessment of satisfaction with the intervention program, rated on a 4-point scale that ranges from 1 to 4 in each item. Higher scores indicate greater satisfaction with the intervention.
Intervention Fidelity
时间窗: Week 7(post-6-week intervention)
All intervention sessions will be video recorded and a random 20 percent will be rated by independent evaluators trained by the principal investigator. Intervention fidelity for both groups will be assessed using the PST Provider Checklist. The a priori criterion for adequate fidelity was that equal or greater than 80 percent of intervention sessions are rated with equal or greater than 80 percent of adequate fidelity for the MAX Intervention group while less than 20 percent of intervention sessions are rated with equal or lesser than 20 percent of adequate fidelity for the Health Education group.
Changes in fatigue
时间窗: Baseline to Week 11 (4 weeks post-intervention)
The PROMIS® Item Bank v1.0 - Fatigue - Short Form 13a (FACIT-Fatigue) is a 13-item questionnaire designed to assess fatigue levels and their impact on daily activities and quality of life. Each item is scored on a 5-point Likert scale (1 = not at all to 5 = very much), with a total score ranging from 13 to 65. Higher scores indicate greater fatigue, while lower scores suggest less fatigue and better energy levels.
次要结局
- Changes in impact of fatigue in daily life(Baseline to Week 11 (4 weeks post-intervention))
- Changes in fatigue severity(Baseline to Week 11 (4 weeks post-intervention))
- Changes in resilience(Baseline to Week 11 (4 weeks post-intervention))
- Change in physical activity: Step Count(Baseline to Week 11 (4 weeks post-intervention))
- Change in Physical Activity: Energy Expenditure(Baseline to Week 11 (4 weeks post-intervention))
- Change in physical activity: Intensity of Activity(Baseline to Week 11 (4 weeks post-intervention))
研究者
Ketki Raina
Professor
University of Pittsburgh