Together Stronger: A Family-centered Lifestyle Intervention for Black Prostate Cancer Survivors and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 648
- 试验地点
- 1
- 主要终点
- Physical Activity Readiness Questionnaire
研究概览
简要总结
To establish the efficacy of the family-centered intervention in improving healthy lifestyle behaviors (MVPA and overall diet quality), as well as physical functioning, QoL, and family health climate, compared to survivor-only and control groups.
详细描述
Primary Objectives
• Determine the extent to which MVPA and overall diet quality have improved in Black PCa survivors and their caregivers in the family-centered intervention group, compared to those in the survivor-only and control groups at post-intervention.
Secondary Objectives
- Determine the extent to which, compared to those in the survivor-only and control groups, both survivors and caregivers in the family-centered group maintain the MVPA and high diet quality at the 6-month follow-up, and experience improved 6MWT, QoL, and family health climate at both post-intervention and 6-month follow-up.
- Identify mediators and moderators of the family-centered intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria
- •Survivors are eligible if they
- •Are adults (≥18 years old)
- •Self-identify as Black or African American;
- •Were diagnosed with stage 0-III PCa; completed PCa treatment; (5) are able to be physically active, as determined by responses to the Physical Activity Readiness Questionnaire (PAR-Q); and
- •Have a family caregiver willing to participate together. Individuals under active surveillance for PCa will be included.
- •Caregivers are eligible if they:
- •Are adults (≥18 years old)
- •Are able to be physically active, as determined by responses to the
排除标准
- •Survivors are excluded if they:
- •Have a prior history of other cancer or have metastatic cancer.
- •Have planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy during the study period.
- •Meet physical activity recommendations (i.e., 150 min of moderate intensity physical activity per week); and (4) are currently participating in a lifestyle or weight management program.
- •Caregivers are excluded if they:
- •Have serious medical conditions (e.g., cancer, congestive heart failure, stroke, and dementia)
- •Are currently participating in a lifestyle or weight management program.
研究组 & 干预措施
survivor-only intervention
Includes a nutrition education session, a PA education session, and 12 health-coaching calls, all conducted via Zoom or phone.
干预措施: Questionnaire (Other)
Health education control
Will focus on enhancing participants' intrinsic motivation and problem-solving skills related to improving diet quality and engaging in PA. A total of 12 sessions will be provided, with approximately 2 sessions per month
干预措施: Education sessions (Other)
Family-centered intervention
Includes a nutrition education session, a PA education session, and 12 health-coaching calls, all conducted via Zoom or phone.
干预措施: Education sessions (Other)
Family-centered intervention
Includes a nutrition education session, a PA education session, and 12 health-coaching calls, all conducted via Zoom or phone.
干预措施: Questionnaire (Other)
survivor-only intervention
Includes a nutrition education session, a PA education session, and 12 health-coaching calls, all conducted via Zoom or phone.
干预措施: Education sessions (Other)
Health education control
Will focus on enhancing participants' intrinsic motivation and problem-solving skills related to improving diet quality and engaging in PA. A total of 12 sessions will be provided, with approximately 2 sessions per month
干预措施: Questionnaire (Other)
结局指标
主要结局
Physical Activity Readiness Questionnaire
时间窗: Through study completion; an average of 1 year
次要结局
未报告次要终点