NCT05508412已完成不适用
CancerPEP Phase 2 Randomized Trial: Feasibility of a Comprehensive Cancer Patient Empowerment Program Providing Immediate Versus Delayed Stress Reduction Biofeedback Equipment
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Feasibility (accrual, attrition, compliance, and adverse events)
研究概览
简要总结
The Cancer Patient Empowerment Program is a comprehensive health promotion program aiming to improve the quality of life as well as both physical and mental health in cancer patients and survivors. The program includes daily email communications over 6 months that encourage strength and aerobic exercise, yoga, stress reduction techniques, dietary improvements, and more.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of a cancer diagnosis as per the participant's report.
- •Safe to exercise and do strength training. Participants who have recovered from a minor stroke or heart condition in the past will require approval from their Family Physician or Cardiologist to participate in the study.
- •Participants with advanced cancer (including cancer spread to bones) will need approval from the Study Physician or their Oncologist to participate.
- •Existing (or willingness to create) email account and willingness to access email daily.
- •Ability to follow website links to watch YouTube videos.
- •Ability to understand and speak English.
- •Ability to participate in low to moderate levels of physical activity and strength training.
- •Ability and willingness to fill out an online survey at baseline, and 6, 12 and possibly 24 months, and a weekly compliance survey for the six months of the program.
- •Deemed to have an expected survival greater than 1 year and expected to be well enough to complete the six-month training
排除标准
- •Patients deemed unfit to participate in low to moderate level exercise e.g., including but not limited to a myocardial infarction or stroke within the last year, without approval from their Family Physician or Cardiologist that they are safe to exercise.
- •Unable to access the internet and lack of a computer or smartphone to receive emails required for study intervention, or unable to click on a link to successfully watch a YouTube video.
- •Those with a predicted survival less than 1 year, or not expected to be able to participate in the program for six months.
研究组 & 干预措施
Intervention with HRV monitor
Experimental
干预措施: CancerPEP (Behavioral)
Intervention without HRV monitor
Experimental
干预措施: CancerPEP (Behavioral)
结局指标
主要结局
Feasibility (accrual, attrition, compliance, and adverse events)
时间窗: 6 - 24 months
As measured by accrual, attrition, compliance rates, and safety by number of adverse events.
次要结局
- Sexual functioning in women assessed by the 6-item Female Sexual Function Index (FSFI-6).(6 - 24 months)
- Mental Health as assessed by the Kessler Kessler Psychological Distress Scale (K10)(6 - 24 months)
- Health-Related Quality of Life as assessed by the Functional Assessment of Cancer Therapy - General (FACT-G)(6 - 24 months)
- Smoking habit assessed by the Global Adult Tobacco Survey 2020 (GATS).(6 - 24 months)
- Availability of social support assessed by the MOS Social Support Survey(6 - 24 months)
- Personality as assessed by the Ten-Item Personality Inventory (TIPI)(6 - 24 months)
- Alcohol Habit assessed by questions from the NIH Alcohol Consumption questionnaire.(6 - 24 months)
- Comorbidity level assessed by the modified Charlson Comorbidity Index (CCI)(6 - 24 months)
- Satisfaction with Life Scale (SWLS).(6 - 24 months)
- Diet assessed by the Rapid Eating Assessment for Participants (REAP-S).(6 - 24 months)
- Relationship satisfaction as assessed by the Dyadic Adjustment Scale (DAS-32).(6 - 24 months)
- Sedentary behaviour measured by the Sedentary Behaviour Questionnaire (SBQ) for Adults.(6 - 24 months)
- Sexual functioning in men assessed by the Sexual Health Inventory in Men (SHIM).(6 - 24 months)
- Anxiety severity assessed by the GAD-7.(6 - 24 months)
- Brief Illness Perception Questionnaire (IPQ).(6 - 24 months)
- General Health (Physical and Mental) Quality of Life assessed by the 12-item Short Form Health Survey (SF-12)(6 - 24 months)
- Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)(6 - 24 months)
- Center for Epidemiologic Studies Depression Scale (CES-D).(6 - 24 months)
研究者
Gabriela Ilie
Associate Professor
Dalhousie University
研究点 (1)
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