Project 3 - Phase II, Preference Based, Randomized Controlled Trial of Group-Based, In Person Versus Virtual, Cancer Rehabilitation for People With Metastatic / Advanced Breast or Colorectal Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Drop-out rates as a measure of feasibility (demand/update of intervention)
研究概览
简要总结
The proposed study is a Phase II, feasibility, randomized controlled preference based study. This will be conducted in Vancouver and Toronto and includes breast and colorectal cancers.
详细描述
Cancer rehabilitation interventions that address common impairments and focus on maintaining or reducing the rate of functional decline are greatly needed for the growing population of cancer survivors living with incurable or metastatic cancer. In the curative setting, the main gaps in care include lack of referral and barriers to access care; however, in the metastatic setting, high quality evidence on safety, acceptability, and efficacy is still required. In response, based on the results of a need assessments (n=50) of this population and input from palliative care experts, we recently developed the CaRE-Advanced Cancer (CaRE-AC) program. Similar to CaRE@ELLICSR, CaRE-AC is an 8-week multidimensional, group-based program with exercises classes and selfmanagement skills teaching. A single-arm phase I pilot of this program is currently being conducted to assess the feasibility and acceptability (Co-PIs Jones/Langelier). To date, 14 patients have enrolled and 9 patients have completed the program (64%). All participants reported feeling the program was safe and 90% were satisfied with the structure and content.
Data collection is expected to be complete be the end of 2019 and the findings will inform revisions to the program format and content. To build on this work, Project Three is a Phase II feasibility RCT of the CaRE-AC program. Results will inform the development of a multicentre pragmatic RCT protocol.
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
- •Age 18 years or older
- •Diagnosed with locally advanced incurable or metastatic breast or colorectal cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Fully independent with ambulation and transfers with or without ambulatory assistance
- •Palliative Performance score of >70 (moderate predictive power estimating life expectancy >6 months)
- •Receiving first or second line anti-cancer treatments in the metastatic / incurable setting (a relative proxy for expected survival >6 months)
- •Medical clearance to participate from treating physician
排除标准
- •Wheelchair level community ambulation
- •Moderate or severe non-cancer pain (>6 out of 10 on visual analog scale)
- •Moderate or severe cancer bone pain (>Gr 2 bone pain (i.e., moderate pain limiting instrumental ALDs or worse) as measured on CTCAE (see below))
- •Severe or uncontrolled depressive symptoms (>20 on PHQ-9)
- •Known neurological conditions influencing cognition and preventing safe or appropriate engagement with self-management and exercise recommendations (e.g., dementia, traumatic brain injury, or brain metastasis influencing cognition or causing moderate-to-severe motor-sensory-coordination). Best determined by the referring physician or nurse practitioner.
- •Unable to communicate sufficiently in English to complete intervention, questionnaires, and consent.
- •Unwillingness to be randomized, participate in a group intervention, or attend individual physical assessments.
- •Inability to operate videoconferencing if preference is virtual programming.
研究组 & 干预措施
Standard best cancer practice
All participants (intervention arms 1 and 2, and control) will receive usual oncology care by their health care providers which includes recommendations for general aerobic and resistance exercise. Participants in the control group will be of recommended to work towards the recommended 90 minutes moderate to vigorous aerobic exercise, and two days a week of large muscle group strength training as recommended by the ACSM. A general brochure will be provided to all control participants providing education in line with current standard of care. This safety precautions noted these will be indicated brochure will have an open text field on the back which will allow the kinesiologist to provide and general advice at each time point. If there are particular here. Participants in all study arms may also be referred by treating health care providers to usual supportive care or early palliative care services at any time deemed necessary, and will be recorded as part of monthly data collection.
In-person Intervention arm
The in-person intervention arm is an 8-week program and four week short maintenance period. This includes 1 hr of in-person, group-based exercise guided by a qualified exercise professional followed by 1 hr of in-person, group based, self-management education provided by a rehabilitation expert to occur immediately following the exercise session. Each participant is given a FitBit® to track steps, heart rate and sleep. Each site (i.e., Toronto and Vancouver) will run independent, in-person exercise and educational programs based on local referrals. Self management sessions include 8 high priority topics for advanced cancer patients including: 1) goal setting, 2) managing pain, 3) reducing fatigue and improving sleep, 4) boosting brain health, 5) eating and cooking for wellness, 6) managing emotions, 7) being mindful, and 8) planning for the future. Education sessions will be run by local experts at each site.
干预措施: In-person rehabilitaiton group (Behavioral)
Virtual Intervention arm
The virtual intervention arm will be an 8-week program plus four week short maintenance period but will include two separate 1 hour sessions per week. This includes: 1) 60 minutes of virtual, group-based, synchronous exercise over a virtual secure platform; and, 2) A separate 60 min virtual synchronous education session provided on a separate day (to prevent virtual fatigue). 3) Encouragement to participate in a home program the other days of the week, striving for the recommended 90 min of moderate to vigorous aerobic exercise and 2 days of week or resistance exercise. The virtual intervention group will combine participants across both study locations and run sessions when sufficient numbers are recruited. Self-management education content will be unchanged to the in-person sessions but conducted over a virtual platform (i.e., videoconferencing) with participants also attending virtually.
干预措施: Virtual rehabilitation group (Behavioral)
结局指标
主要结局
Drop-out rates as a measure of feasibility (demand/update of intervention)
时间窗: 6 months
Number of patients who complete the study/ drop-out will be used to identify feasibility of the intervention.
Patient preference as assessed during clinical support as a measure of feasibility (acceptability)
时间窗: 6 months
Check-ins with Kinesiologist during assessments will be used to identify intervention acceptability/preference.
Measuring safety/practicality as assessed during one-on-one with the health coach (analyzed as qualitative data)
时间窗: 6 months
Completed over MS Teams/in-person and will be a conversational question and answer format.
次要结局
- Physiological measures of muscular strength(6 months)
- Physiological measures of cardiorespiratory fitness(6 months)
- Demographics(6 months)
- Disability(6 months)
- Physical functioning(6 months)
- Social functioning(6 months)
- Depression(6 months)
- Anxiety(6 months)
- Physicial activity(6 months)
- Quality of Life for advanced cancer - daily life activities(6 months)
- Quality of Life for advanced cancer - wellbeing(6 months)
- Symptom Burden(6 months)
- Safety and Health Care Utilization(6 months)
- Weekly Session feedback(8 weeks)
- Physiological measure of height(6 months)
- Physiological measures of weight(6 months)
- Physiological measures of exercise Intensity (Perceived Exertion)(6 months)
- Physiological measures of total Exercise Participation for sleep(6 months)
- Physiological measures of total Exercise Participation for step count(6 months)
- Physiological measures of total Exercise Participation for heart rate.(6 months)
- Physiological measures of endurance(6 months)
- Physiological measures of balance(6 months)
- Physiological measures of Performance(6 months)