A Pilot, Randomized Controlled Trial Adding Behavioral Counseling to Supervised Physical Activity in Prostate Cancer Survivors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Objectively assessed physical activity
研究概览
简要总结
This study will evaluate the feasibility of delivering a supervised physical activity program plus standard exercise counseling (SPA+EC) versus a supervised physical activity plus motivationally-enhanced behavioral counseling (SPA+BC) in prostate cancer survivors (PCS). Fifty participants (n=25) will be randomized to receiving SPA+EC or SPA+BC (n=25). We hypothesize that PCS receiving the SPA+BC intervention will result in greater increases in objectively-assessed physical activity compared with PCS receiving the SPA+EC intervention.
详细描述
Physical activity (PA) has a positive impact on clinical outcomes such as improvement in overall QoL, cancer-specific mortality, reducing treatment-related toxicities, and reducing fatigue across many cancer survivor groups including PCS. Despite these benefits of regular PA, the majority of PCS are still not meeting public health PA guidelines.
Short-term supervised PA programs have been shown to improve health-related fitness and patient-reported outcomes in PCS, but PA declines significantly after the supervised intervention has been completed. Research examining the effect of short- term supervised exercise programs on motivational outcomes and longer term PA among cancer survivors is limited, especially theoretical approaches to identify key motivational outcomes for behavior change.
This study will pilot a two-armed, single blind, RCT comparing SPA+EC to SPA+BC. The proposed RCT in PCS is noteworthy given that it differs from standard approaches to supervised PA with the addition of a behavioral counseling component. This rigorous comparison condition will provide further evidence that theoretically-informed interventions are needed to adopt long-term PA maintenance.
The program's supervised exercise length will be 6 weeks, followed by a tapered contact throughout the a 6-week home-based component through 'booster' behavioral counseling delivered via telephone. In terms of study measures, objective measures of PA will be used (i.e.,accelerometry, inclinometers), and cardiorespiratory fitness will be evaluated using maximal graded exercise testing via treadmill. Additional secondary outcomes include cognitive function, quality of life, physical function, body composition, motivational outcomes, sexual functioning, masculinity, sedentary behavior, and cardiorespiratory fitness.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •≥18 years and older
- •Histologically confirmed prostate cancer (Stage I-IIIa) but now cured or in remission
- •Ability and willingness to effectively communicate in English
- •Not meeting physical activity guidelines of ≥150 minutes of vigorous physical activity
排除标准
- •Severe coronary artery disease (Canadian Cardiovascular Society class III or greater)
- •Significant congestive heart failure (New York Heart Association class III or greater)
- •Uncontrolled pain
- •Neurological or musculoskeletal co-morbidity inhibiting exercise
- •Diagnosed psychotic, addictive or major cognitive disorders
- •Absent for more than 3 consecutive days during the 12-week intervention
- •High risk individuals (i.e., men who have symptomatic and known cardiovascular, pulmonary and/or metabolic disease) as determined by the risk stratification questionnaire
结局指标
主要结局
Objectively assessed physical activity
时间窗: Change in from baseline at 12 weeks
Objective Physical activity will be measured using an activity device, accelerometry (i.e., Actigraph GTX3+)
次要结局
- Physical Function(Change in from baseline at 12 weeks)
- General well-being(Change in from baseline at 12 weeks)
- Masculine self-esteem(Change in from baseline at 12 weeks)
- Self-reported physical activity(Change in from baseline at 12 weeks)
- General quality of life(Change in from baseline at 12 weeks)
- Prostate-specific quality of life(Change in from baseline at 12 weeks)
- Cancer-related fatigue(Change in from baseline at 12 weeks)
- Body composition(Change in from baseline at 12 weeks)
- Cognitive function(Change in from baseline at 12 weeks)
- Cardiorespiratory fitness(Change in from baseline at 12 weeks)
- Relationship quality(Change in from baseline at 12 weeks)
- Sexual Health(Change in from baseline at 12 weeks)
- Motivational outcomes(Change in from baseline at 12 weeks)
- Self-reported sedentary behavior(Change in from baseline at 12 weeks)
- Objectively assessed sedentary behavior(Change in from baseline at 12 weeks)