A Pilot Study for Optimizing Mental Wellbeing and Heart Health for Black Patients With Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Proportion of Completers
研究概览
简要总结
Pilot study to determine the feasibility of providing psychosocial and cardiac rehabilitation services to address socioeconomic health disparities and improve wellbeing for black men with prostate cancer.
详细描述
Subjects will see an oncology Associate Clinical Social Worker at Stanford's Cancer Center for a two hour psychosocial assessment. Subsequently participants will complete the psychosocial intake support session and elective additional counseling sessions (Part A) at the end of up to 8 counseling sessions (maximum sessions possible) or 20 weeks (+/- 4 weeks), whichever comes first. For participants who continue onto cardiac services (Part B), the participant will complete the cardiac rehabilitation exercise program within 12 weeks (+/- 2 weeks) of the first day of exercise start. The end of study will occur after the last cardiac rehabilitation exercise session (+ 2 weeks).
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
- •for Part A (Mental Health Services)
- •Self-Identify as Black and/or African American.
- •Diagnosed with prostate cancer currently or any time in the past (per medical history; pathology not required, active prostate cancer at time of enrollment is not required).
- •Males >= age
- •All participants must have a life expectancy of > 6 months.
- •Participants must have the ability to understand and the willingness to sign a written informed consent document in English, and the willingness/ability to comply with the protocol activities.
- •Ability to wear a face mask during all in-person sessions (when required).
- •Participants must complete the psychosocial intake (Part A, Visit A1) in order to enroll in a cardiac rehabilitation program (Part B).
- •Additional Inclusion Criteria for Part B (Cardiac Services)
- •Have completed the psychosocial intake portion of Visit A1 (as documented by clinical social worker).
- •Meets at least one of the following ([a] or [b]):
- •planning to receive androgen deprivation on Day 1, or is currently, or was formerly, on androgen deprivation therapy. It is acceptable for participant to switch/transition to another form of androgen deprivation therapy while in the study. Participant may be receiving or planning to receive additional systemic therapy concurrent with androgen deprivation.
- •^ treatment with single agent testosterone-blocking agents (such as, but not limited to bicalutamide) will also be eligible
- •patients with a cardiac risk factor may enroll. Cardiac risk factors include, but are not restricted to: pre-hypertension, hypertension, metabolic syndrome, tobacco history, coronary artery disease, CVA/TIA, peripheral vascular disease, obesity, hypercholesterolemia, hyperglycemia, heart failure, or any other cardiac condition based on the discretion of the investigators.
- •Participants must have an ECOG Performance Status of <= 2 or at the investigator's discretion, will have the ability to participate in a cardiac rehab program.
- •Participants must be able and willing to follow the cardiac rehabilitation activities.
- •Participant must have a smartphone or tablet to use for the cardiac rehabilitation app.
- •Exclusion Criterion for Part A (Mental Health Services)
- •* Actively engaging in self harm, or currently on a 5150 or 5250.
排除标准
- •for Part B (Cardiac Services)
- •Uncontrolled angina, active acute coronary syndrome (e.g., unstable angina or acute MI) or poorly controlled arrhythmias.
- •In the opinion of the Principal Investigator, have a clinically significant comorbid disease that is likely to affect the ability of the patient to complete the trial, interfere with their ability with measurement of self-reported outcomes.
研究组 & 干预措施
Psychosocial intervention + Cardiac Rehab Services
Cognitive Behavioral Therapy + Cardiac Rehab
干预措施: Cognitive behavioral therapy (supportive counseling) (Behavioral)
Psychosocial intervention + Cardiac Rehab Services
Cognitive Behavioral Therapy + Cardiac Rehab
干预措施: Virtual Cardiac Rehabilitation (Behavioral)
结局指标
主要结局
Proportion of Completers
时间窗: 12 weeks
Proportion of screened eligible participants who complete the initial 2-hour psychosocial support session intake. The pilot study is considered feasible if the primary endpoint is met in at least 50% of patients. We will evaluate the 95% CI of the feasibility rate.
次要结局
- Difference of General Anxiety Disorder-7 (GAD-7) score(12 weeks)
- Difference of Functional Assessment of Cancer Therapy-Prostate (FACT-P) score(12 weeks)
- Difference in Patient Health Questionnaire-9 (PHQ-9)(12 weeks)
研究者
Alice Fan
Associate Professor of Medicine (Oncology) and, by courtesy, of Urology
Stanford University