NCT06250751已完成不适用
Behavioral Exercise TRaining for Medically Underserved Men Undergoing Androgen Deprivation Therapy for Prostate Cancer (BETR-PC)
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
- 27
- 试验地点
- 2
- 主要终点
- Acceptability of the trial by assessing the retention rate
研究概览
简要总结
To refine a remote behavioral exercise training intervention for testing in a larger randomized trial.
详细描述
Determine feasibility of recruiting a sample of medically underserved prostate cancer patients undergoing treatment with Androgen Deprivation Therapy (ADT) to a remotely delivered (i.e., home-based) exercise intervention and determine the interventions acceptability.
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
- 41 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •To be eligible men, transwomen or non-binary individuals must meet the following criteria:
- •Be diagnosed with stage II/III/IV prostate cancer
- •Be currently undergoing treatment with ADT (intermittent or prolonged)
- •Have completed local curative-intent treatment, including prostatectomy or definitive radiation
- •Be >40 years of age if non-Hispanic Black or rural dwelling; Otherwise >60 years of age up to 85
- •Be willing to give an informed consent and sign a HIPAA authorization form
- •Not have any hearing or sight impairments that result in the inability to use the telephone or hear normal conversation
- •Must be able to join an intervention group by personal computer, smartphone or telephone call and should agree to recording of an interview
- •Be without any serious medical condition that precludes safe participation in an exercise program
- •Speak English.
- •Meet protocol definition of medically underserved: which is consider medically underserved patients to be a) older men (>75 years), b) men who live in rural zip code areas, or c) men who identify as being non-Hispanic Black. They may also be at the intersectionality of these groups (i.e., older Black men living in a rural zip code area).
排除标准
- 未提供
研究组 & 干预措施
Behavioral exercise training (BET) to introduce behavioral skills for adopting an exercise program
Experimental
Single-arm, ORBIT-prospective, multicenter, nonblinded clinical trial, feasibility pilot. The BET intervention will be delivered and refined over 12 weeks. The protocol aim is to enroll men from the same representative groups of underserved men in groups of 5-10, to foster social support and group cohesion.
干预措施: Behavioral Exercise Training (BET) intervention (Behavioral)
结局指标
主要结局
Acceptability of the trial by assessing the retention rate
时间窗: 12 Weeks
Number of participants that adhere to and complete the intervention
Feasibility of trial by assessing the recruitment rate
时间窗: Day 1
The number of participants that enroll
Feasibility of trial by assessing the retention rate
时间窗: 12 Weeks
The number of participants that complete greater than 80% of the planned assessments
次要结局
- Self-efficacy for exercise using the exercise self-efficacy scale (EXSE) to assess socioecological model constructs as multilevel factors associated with physical activity levels and behavioral patterns(Baseline, 8 Weeks, and 12 Weeks)
- Social support for exercise scale to assess socioecological model constructs as multilevel factors associated with physical activity levels and behavioral patterns(Baseline, 8 Weeks, and 12 Weeks)
- Physical activity levels using accelerometry (ActivPAL, Actigraph)(Baseline, 8 Weeks, and 12 Weeks)
- Submaximal exercise capacity assessed with the 6-minute walk test.(Baseline, 8 Weeks, and 12 Weeks)
- Lower body strength assessed with a 30 seconds chair stand test.(Baseline, 8 Weeks, and 12 Weeks)
- Assess health-related quality of life (HRQL) using the Functional Assessment of Cancer Therapy-Fatigue scale (FACIT-fatigue)(Baseline, 8 Weeks, and 12 Weeks)
- Assess disease specific quality of life (HRQL) using the 42-item Functional Assessment of Cancer Treatment-Prostate (FACT-P)(Baseline, 8 Weeks, and 12 Weeks)
- Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression Scale 4a(Baseline, 8 Weeks, and 12 Weeks)
- Upper body strength assessed with a grip strength dynamometer.(Baseline, 8 Weeks, and 12 Weeks)
- Assess health-related quality of life (HRQL) using the the MOS 36-item Short Form Health Survey (SF-36)(Baseline, 8 Weeks, and 12 Weeks)
- Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety Scale 4a(Baseline, 8 Weeks, and 12 Weeks)
- Physical activity levels using the Godin-Leisure Time Exercise Questionnaire (GLTEQ).(Baseline, 8 Weeks, and 12 Weeks)
- Walk Score to assess socioecological model constructs as multilevel factors associated with physical activity levels and behavioral patterns(Baseline, 8 Weeks, and 12 Weeks)
- Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Scale 4a(Baseline, 8 Weeks, and 12 Weeks)
- Physical function as assessed with the short physical performance battery (SPPB).(Baseline, 8 Weeks, and 12 Weeks)
- Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue Scale 4a(Baseline, 8 Weeks, and 12 Weeks)
- Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Scale 4a(Baseline, 8 Weeks, and 12 Weeks)
- Assess health-related quality of life (HRQL) using Social Determinants of Health(Baseline, 8 Weeks, and 12 Weeks)
研究者
研究点 (2)
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