PROWESS (PROstate Cancer Wearables Exercise and Structured Supports): A Pilot Supportive Care Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Participant Satisfaction
研究概览
简要总结
The goal of this research study is to conduct an open pilot of a behavioral change intervention called PROstate Cancer Wearables, Exercise, and Structured Supports (PROWESS) for integrating health behavior change tools and to increase exercise, reduce side effects of androgen deprivation therapy (ADT), and improve quality of life in Black and Hispanic/Latino men with prostate cancer.
The name of the intervention used in this research study is:
PROWESS (behavioral change intervention)
详细描述
This research study is to test a behavioral change intervention called PROstate Cancer Wearables, Exercise, and Structured Supports (PROWESS) for integrating health behavior change tools with wearable technology, to increase exercise, reduce side effects of androgen deprivation therapy (ADT), and improve quality of life in Black and Hispanic/Latino men with prostate cancer on androgen deprivation therapy (ADT).
Study procedures include screening for eligibility, intervention sessions, questionnaires and surveys, and an exit interview with study staff.
Participation in this research study is expected to last for up to four months.
The goal and primary outcome of this open pilot study is refinement of the intervention and study procedures to allow for us to conduct a larger feasibility study in the future.
It is expected that about 10 people will take part in this research study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Diagnosed with prostate cancer.
- •Planning to be on androgen deprivation therapy (ADT) for at least three months
- •Black Race AND/OR Hispanic/Latino Ethnicity (confirmed by patient self-report)
- •Verbal fluency in English or Spanish.
- •Receiving ongoing oncology care at MGH Cancer Center.
- •Age ≥ 18 years.
- •Self-Report less than or equal to 150 minutes of moderate or vigorous structured exercise per week, as assessed by the Exercise is Medicine Physical Activity Vital Sign Assessment
- •Completion of baseline assessment
排除标准
- •Unwilling or unable to participate in the study.
- •Significant psychiatric, cognitive or other comorbid disease which the treating clinician believes prohibits informed consent or participation in the study.
- •Currently receiving chemotherapy.
- •Prognosis less than 6 months, per the judgment of the primary oncologist.
- •Medical contraindication to physical activity, as assessed by outpatient oncologist.
结局指标
主要结局
Participant Satisfaction
时间窗: At week 8-12 (intervention completion)
Assessed by the Client Satisfaction Questionnaire-3 (CSQ), a 3-item survey with answers ranging from 1-4, "quite dissatisfied" to "very satisfied."
次要结局
- Change in Objective Physical Activity(At Baseline and from weeks 1 - 12)
- Change in Self-Reported Exercise(At Baseline and weeks 8-12)
- Change in Participant Quality of Life(At Baseline and weeks 8-12)
- Change in Psychological Distress Symptoms(At Baseline and weeks 8-12)
- Change in Self-Efficacy for Managing Symptoms(At Baseline and weeks 8-12)
研究者
Daniel E Lage, MD, MSc
Principal Investigator
Massachusetts General Hospital