Building Resiliency Among Caregivers of Curvivors and Metavivors: A Pilot Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Proportion of Enrolled Participants (Feasibility)
研究概览
简要总结
The main purpose of this research study is to assess the feasibility and participants' satisfaction of the Stress Management and Resiliency - Relaxation Response Resiliency Program (SMART-3RP) and compare this treatment with SMART-3RP versus referral to a group-based, online support group to see which is better for improving resilience and decreasing distress of participants with cancer and their caregivers.
The name of the study intervention involved in this study is:
Smart-3RP (virtual, mind-body group treatment program).
详细描述
This pilot, randomized controlled trial assesses the feasibility, acceptability, and efficacy of the Stress Management and Resiliency - Relaxation Response Resiliency Program (SMART-3RP) for improving resiliency and decreasing distress among caregivers and cancer survivors compared to enhanced usual care.
Participants will be randomly assigned into one of the study groups: Smart-3RP versus referral to a group-based, online support group. Randomization means that a participant is placed into a group by chance.
Participation in this study is expected to last about 180 days.
It is expected about 96 people made up of 48 patients and 48 caregivers will take part in this research study.
The National Institutes of Health (NIH) is supporting this research by providing funding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for Patients:
- •English speaking adult patients with cancer (18 years or older)
- •Treated at MGH, who are either within approximately:
- •3 months to 3 years after completing potentially curative therapy for cancer diagnosis including surgery, radiation, and/or chemotherapy or other novel therapies (e.g., immunotherapy, biological therapy). Patients can be on long- term maintenance hormonal or biological therapy at the time of enrollment.
- •3 months after diagnosis of metastatic disease with an expected prognosis of >1 year as confirmed by the treating oncology clinician
- •Able to identify a caregiver (i.e., spouse/partner or patient-identified family member or friend) who is willing to participate in the study
排除标准
- •for Patients:
- •Prognosis less than one year as determined by the treating oncology clinician
- •Active psychiatric or cognitive comorbidity that prohibits the capacity to provide informed consent as determined by the treating oncology clinician
- •Patients without a caregiver who is willing to participate
- •Inclusion Criteria for Caregivers:
- •Adult caregiver (age 18 years or older).
- •Identified by the patient as the spouse/partner or family member/friend.
研究组 & 干预措施
Smart-3RP
Survivors-caregivers will be randomized together (dyad), stratified by survivor status: curvivor (participants who have completed curative therapy) or metavivor (participants will metastatic disease), using a random plan generator with 1:1 randomization. Participants will complete study procedures as outlined:
- Baseline questionnaires.
- 9 virtual sessions of Smart-3RP.
- 3-month questionnaires.
- Optional collections of hair samples at enrollment and 6-month follow-up period to measure cortisol concentration.
- 6-month questionnaires.
- Optional exit interview with study staff.
干预措施: Smart-3RP (Behavioral)
Enhanced Usual Care
Survivors-caregivers will be randomized together (dyad), stratified by survivor status (curvivor/metavivor), using a random plan generator with 1:1 randomization.
- Participants will be referred to a 14-week online support group.
干预措施: Enhanced Usual Care (Behavioral)
结局指标
主要结局
Proportion of Enrolled Participants (Feasibility)
时间窗: At Screening
Defined as the percent of survivors/caregivers (counted as individuals) who are eligible and enroll, with a feasibility cutoff of ≥ 45% enrollment of eligible dyads (defined as a survivor + caregiver).
Proportion of Intervention Satisfaction (Acceptability)
时间窗: At 3 months
Defined as the percent of participants (including survivors and caregivers as individuals) who report overall intervention satisfaction as greater than or equal to 4 on 5-point Likert scales, with an acceptability cutoff of ≥ 75% of participants. This metric is relevant only to participants randomized to the SMART-3RP condition.
次要结局
- Proportion of Intervention Session Completion (Feasibility)(up to 6 months)
- Improvement in Resilience (Exploratory outcome)(At baseline and 3 months)
- Improvement in stress coping (Exploratory outcome)(At baseline and 3 months)
- Health care utilization (exploratory outcome)(At baseline and 6 months)
- Reduction of Chronic Stress(At baseline and 6 months)
- Proportion of Study Retention (Feasibility)(At 3 months)
- Proportion of Intervention Session Completion (Feasibility)(3 months)
研究者
Elyse Park, PhD
Principal Investigator
Massachusetts General Hospital