GET FIT Together: Testing a Socially Enhanced Exercise Program in Older Men With Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cancer loneliness
研究概览
简要总结
This clinical trial tests the impact of different levels of social support on the benefits of exercise in older men with prostate cancer. This trial compares a socially-enhanced supervised group exercise program to a supervised group exercise program with no social enhancement, and an unsupervised home-based program on cancer loneliness, social isolation, mental and physical health in older prostate cancer survivors. All study arms exercise for 6 months and outcomes are measured at baseline, 3 and 6 months. The primary outcome is cancer loneliness with secondary outcomes of mental and physical health.
详细描述
PRIMARY OBJECTIVE I. Determine the preliminary efficacy of socially-enhanced supervised group exercise on cancer loneliness and social isolation in older PCS.
SECONDARY OBJECTIVE:
I. Examine potential mediators of the effect of socially-enhanced supervised group exercise on cancer loneliness (social support for exercise, cancer-related negative social expectations and self-efficacy).
TERTIARY OBJECTIVE:
I. Determine the preliminary efficacy of socially-enhanced supervised group exercise on mental health (anxiety, depressive symptoms) and physical health (fatigue and physical function) in older PCS.
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
- Single (Outcomes Assessor)
盲法说明
To retain blinding of the research assistants who conduct the testing visits, the Project Director will send each participant an email that contains his random group assignment after baseline testing is complete.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 65 years of age or older.
- •Diagnosed with histologically confirmed prostate cancer.
- •Completed surgery, chemotherapy, radiation and/or systemic treatment (other than ADT) for cancer > 3 months ago.
- •Experiencing cancer loneliness.
- •Able to ambulate independently; reliance on assistive devices other than a wheelchair is allowed.
- •Willing to be randomized into any of the three study arms and attend 80% or more of planned exercise sessions.
- •Home internet sufficient for videoconferencing.
排除标准
- •Participating in regular group exercise and/or structured resistance training with other cancer survivors (> 1 exercise partner or groups of 3 or more).
- •Health or medical condition that affects movement or neurological disorder, or medication that contraindicates participation in live remote resistance exercise.
- •Cognitive difficulties that preclude answering the survey questions, participating in the intervention, or giving informed consent.
- •Not fluent in English and therefore incapable of answer survey questions, following directions during exercise or performance testing, and providing informed consent in English.
研究组 & 干预措施
Arm I (Socially enhanced supervised group exercise)
PCS participate in online supervised group exercise training led by a certified exercise instructor over 60 minutes with additional 15-minute pre-exercise social time 3 times weekly over 6 months.
干预措施: Socially enhanced supervised group exercise (Behavioral)
Arm II (Supervised group exercise)
PCS participate in online supervised group exercise training led by a certified exercise instructor over 60 minutes 3 times weekly over 6 months.
干预措施: Exercise Intervention (Behavioral)
Arm III (Unsupervised independent exercise)
PCS participate in independent exercise training following written manual and/or video over 60 minutes 3 times weekly over 6 months. Men have two one-hour training sessions with the trainer to learn the exercises and then the trainer will check in monthly.
干预措施: Unsupervised independent exercise (Behavioral)
结局指标
主要结局
Cancer loneliness
时间窗: Baseline, 3- and 6-months
Assessed by the 7-item Cancer Loneliness scale measures cancer-related loneliness. Each items asks how often people experience a feeling of loneliness specific to having cancer, such as "how often do you feel others cannot provide the support your need to deal with your cancer?" on a Likert scale of 1 (never) to 5 (always). Responses are averaged and scores range from 1-7 with higher scores indicating greater feelings of cancer loneliness. The scale has excellent reliability and construct validity in adult cancer survivors.
次要结局
- General loneliness(Baseline, 3- and 6-months)
- Social isolation(Baseline, 3- and 6-months)
- Physical health(Baseline, 3- and 6-months)
- Mental health(Baseline, 3- and 6-months)
研究者
Kerri Winters
Principal Investigator
OHSU Knight Cancer Institute