Pragmatic Hybrid Type 1 Effectiveness-implementation (E-I) Trial of a Virtual Cancer Rehabilitation Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 388
- 试验地点
- 2
- 主要终点
- Disability
研究概览
简要总结
Pragmatic hybrid type 1 effectiveness-implementation (E-I) trial of a virtual cancer rehabilitation program: The study team will conduct a multi-center hybrid type I effectiveness-implementation study to examine the clinical effectiveness and implementation potential of an 8-week multidimensional virtual cancer rehabilitation intervention (CaRE@Home) for cancer survivors with identified cancer-related impairments on level of overall disability (primary outcome) and patient reported physical and social functioning, anxiety, work status, quality of life, and physiologic changes (secondary outcomes). The study team will conduct a multi-centre pragmatic randomized controlled trial (RCT) (Vancouver, Toronto, Saint John and St. John's) to evaluate effectiveness and using the CIFR, the study team will identify potential factors that may affect successful implementation and integration of CaRE@Home in different cancer settings.
详细描述
Comprehensive multidimensional rehabilitation programs that include both exercise and self management education have the potential to concurrently improve a wide range of post treatment side-effects and overall patient function. In 2017, the Cancer Rehabilitation and Canadian Cancer Rehabilitation (CanRehab) Team: Improving the systematic identification, management, and treatment of the adverse effects of cancer.
Survivorship program at Princess Margaret Cancer Centre launched an evidence driven group based multidimensional Cancer Rehabilitation and Exercise program (CaRE@ELLICSR) for patients who have identified cancer-related impairments. The 8-week program integrates a number of evidence-based techniques to sustain behavioural change and consists of weekly1-hr group exercise classes followed by 1-hr self-management skills education delivered by a rehabilitation expert. Participants return for follow-up at 3 and 6 months post-intervention to monitor progress and adapt exercise as needed. CaRE@ELLICSR has resulted in improvements in overall levels of disability, social functioning, distress, and physical activity. Program satisfaction is high, and wait times are within the target of <1 month. However, access is an issue with ~50% of referred patients unable to participate due to travel distance, transportation costs or competing obligations (unpublished data).
To increase access, a virtual on-line version of the CaRE program (CaRE@Home) was developed using a series of iterative steps proposed by the NCI Research-Tested Intervention Programs.
The CaRE@Home program is currently undergoing single-group feasibility pilot testing (completion Oct 2019, funded by Ontario Institute for Cancer Research). Feasibility outcomes collected to date demonstrate high program acceptability with 95% of referred patients enrolled and 94% program adherence. The final steps of this process are to formally evaluate effectiveness and prepare for real-world implementation, which is the focus of Project Two of this application. If effective, the virtual CaRE@Home program has the potential to extend access to critical cancer rehabilitation services to a greater number of cancer survivors in need. It also has immense potential to be adapted and scaled to other centres that lack the resources required to deliver in-house cancer rehabilitation services. In Project Two the study team will conduct a multi-center hybrid type I effectiveness-implementation study to examine the clinical effectiveness and implementation potential of CaRE@Home for cancer survivors with identified cancer-related impairments.
Principal Research Aims:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) Age 18 years or older
- •2) Diagnosed with breast (stage 0-III), colorectal (stage I-III), head and neck (stage I-III), or lymphoma/lymphoproliferative disorder (excluded: recurrent, refractory, progressive, received or planning to receive transplant)
- •3) Completed a primary treatment (i.e. surgery and/or radiation and/or systemic therapy of any kind) within the last 24 months
- •4) If patients received systemic therapy of a fixed duration with adjuvant/curative intent, the main part should be completed, but patients are eligible if on primary, maintenance, or other adjuvant systemic therapy (e.g. eligible while on trastuzumab, immunotherapy, rituximab, oral endocrine or targeted therapy - ie ibrutinib). Indolent non-curative lymphoma patients are eligible if they have response to systemic therapy
- •5) Communicate sufficiently in English to complete intervention and questionnaires
- •6) Willing to be randomized and participate in the intervention and attend in-person or virtual assessments
- •7) Internet access
- •8) An indication for cancer rehabilitation (WHO-DAS score >5).
排除标准
- •1) Impaired functional status that would preclude rehabilitation (PRFS >3)
- •2) Indication of major depressive disorder (> or = to 20 on PHQ-9)
- •3) Diagnosis of neurological disease or condition significantly limiting cognitive functioning, such as language or memory (e.g., Alzheimer's disease or other dementia, severe traumatic brain injury);
- •4) Currently enrolled in another personalized and supervised exercise or rehabilitation program
- •5) Conditions or current injuries which are not appropriate for distance based exercise (based on intake screening questions and as determined by physician*. *In cases where patient's indicate an existing higher risk condition (i.e high blood pressure, recent heart attach or unstable angina, spinal cord compression, recent deep vein thrombosis) or injury, the study team will contact the physician for medical approval and clearance to participate in the study will be required)
研究组 & 干预措施
CaRE@Home intervention
Individualized exercise plans are created from baseline assessments and progressed toward ACSM targets: moderate aerobic activity 3×/week for 30 minutes and resistance training 2×/week. Plans are updated at check-ins and delivered through Physitrack®, with print copies if needed.
Fitbit™ devices monitor activity, sleep, and heart rate. Participants receive instructions, share data with clinicians, and wear the device for the full study. Data syncs to the clinician dashboard to guide weekly check-ins, with setup support provided.
Participants complete nine online CaRE@Home modules on wellness, fatigue, emotions, mindfulness, cognition, connection, and future planning. Modules use behavior-change strategies, were developed by a multidisciplinary team, and remain accessible through the 3-month maintenance period.
Weekly remote coaching (weeks 2-7) plus two follow-up calls offer tailored feedback, goal-setting, and motivational interviewing to support adherence.
干预措施: CaRE@Home intervention (Behavioral)
Usual Care group
Control-arm participants receive usual oncology care. They are given general exercise recommendations aligned with ACSM guidelines and a brochure that includes space for the kinesiologist to add safety notes or general advice at each assessment. Referrals to supportive care services may occur at any time and will be recorded monthly.
After the T3 assessment, UC participants may opt into the CaRE@Home program without additional study measures beyond what is needed for exercise prescription. They may complete the 8-week e-module program, receive check-in calls during weeks 2-7 plus 1- and 2-month maintenance calls, and attend physical assessments at the end of the 8-week program and 3 months later.
结局指标
主要结局
Disability
时间窗: 6 months
measured using the World Health Organization Disability Assessment Schedule 2.0, which is a cross-cultural standardized method for measuring limitations and restrictions on individuals' activities and participation in society. The average scores are comparable to the WHODAS 5-point scale, he total score for WHODAS ranges from 0-100, where a high score indicates major living limitations ((0-0.49) = none, mild (0.5-1.49), moderate (1.5-2.49), severe (2.5-3.49), or extreme (3.5-4).
次要结局
- Demographics(6 months)
- Physical functioning(8 months)
- Social functioning(8 months)
- Anxiety(8 months)
- Physical activity(8 months)
- Work functioning(8 months)
- Health status(8 months)
- Safety status(8 months)
- Physiological measure of height(8 months)
- Physiological measure of weight(8 months)
- Physiological measures of cardiorespiratory fitness(8 months)
- Grip strength(8 months)
- 30-second sit to stand test(8 months)
- Physiological measures of performance(8 months)