An Online Dyadic Mind-Body Intervention for Glioma Patients and Their Partners
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Feasibility of couple-based mind-body program (CBMB) as determined by overall accrual
研究概览
简要总结
This trial studies how well a couple-based mind body program works in improving spiritual, psychosocial, and physical quality of life in patients with high or low grade glioma or tumors that have spread to the brain and their partners. A couple-based mind body program may help to improve spiritual well-being, sleep difficulties, depressive symptoms, and overall quality of life in patients with glioma or tumors that have spread to the brain and their partners.
详细描述
PRIMARY OBJECTIVES:
I. Examine the feasibility of the couple-based mind-body (CBMB) program in patients with high grade glioma (HGG) and their partners.
II. Establish the initial efficacy of the CBMB program in patients and their partners regarding spiritual (primary), psychological and physical quality of life (QOL) (secondary) outcomes relative to a waitlist control (WLC) group.
EXPLORATORY OBJECTIVES:
I. Explore potential mediation (i.e., mindfulness, compassion, holding back, and intimacy) and moderation (e.g., baseline medical, demographic and psychosocial factors) effects of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- All
- 接受健康志愿者
- 是
入选标准
- •PATIENT ONLY: Patients with a diagnosis of HGG or low grade glioma (LGG), based on radiographic or pathologic diagnosis of grade III or IV listed in the medical records, or patients with a malignancy that has metastasized to the brain
- •PATIENT ONLY: Patients must be within 1 month of initiating or having undergone any type of cancer treatment (i.e., surgery, radiotherapy, chemotherapy)
- •PATIENT ONLY: Karnofsky performance status (KPS) of 80 or above
- •PATIENT ONLY: Having a spouse/romantic partner (including same-sex) and who is willing to participate
- •PATIENT & PARTNER: Able to read and speak English
- •PATIENT & PARTNER: Able to provide informed consent
- •PATIENT & PARTNER: Have access to internet connectivity
排除标准
- •PATIENT ONLY: Regularly (self-defined) participation in psychotherapy or a formal cancer support group
- •PATIENT ONLY: Cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team
研究组 & 干预措施
Group II (waitlist control)
Patients complete questionnaires as in Group I. Patients may undergo CBMB program after completion of study.
干预措施: Questionnaire Administration (Other)
Group I (CBMB program)
Patients undergo CBMB program consisting of 4-5 deep-breathing and meditation exercise sessions over 60 minutes and 2 weekly telephone calls over 15 minutes for 6 weeks. Patients also complete questionnaires regarding health, mood, sleeping habits, relationship, health care, work productivity, and quality of life.
干预措施: Mind-Body Intervention Procedure (Procedure)
Group I (CBMB program)
Patients undergo CBMB program consisting of 4-5 deep-breathing and meditation exercise sessions over 60 minutes and 2 weekly telephone calls over 15 minutes for 6 weeks. Patients also complete questionnaires regarding health, mood, sleeping habits, relationship, health care, work productivity, and quality of life.
干预措施: Quality-of-Life Assessment (Other)
Group I (CBMB program)
Patients undergo CBMB program consisting of 4-5 deep-breathing and meditation exercise sessions over 60 minutes and 2 weekly telephone calls over 15 minutes for 6 weeks. Patients also complete questionnaires regarding health, mood, sleeping habits, relationship, health care, work productivity, and quality of life.
干预措施: Questionnaire Administration (Other)
Group II (waitlist control)
Patients complete questionnaires as in Group I. Patients may undergo CBMB program after completion of study.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Feasibility of couple-based mind-body program (CBMB) as determined by overall accrual
时间窗: Up to 6 weeks
Trial considered feasible if 50% of eligible couples consent. Will calculate rates, frequencies, and 90% confidence intervals (CIs), as applicable.
CBMB program efficacy
时间窗: Up to 6 weeks
Will calculate effect sizes for pairwise between-group comparisons of intervention outcomes at T2. Will test for between-group differences in the change of scores between T1 and T2 using analysis of variance.
Feasibility of CBMB program as determined by attrition
时间窗: Up to 6 weeks
Trial considered feasible if 80% of enrolled couples complete T1 and T2 assessments. Will calculate rates, frequencies, and 90% CIs, as applicable.
Feasibility of CBMB program as determined by adherence
时间窗: Up to 6 weeks
Trial considered feasible if 50% of all sessions are attended. Will calculate rates, frequencies, and 90% CIs, as applicable.
Feasibility of CBMB program as determined by acceptability
时间窗: Up to 6 weeks
Trial considered feasible if \> 75% of patients in the CBMB group rate the intervention as acceptable. Will calculate rates, frequencies, and 90% CIs, as applicable.
次要结局
未报告次要终点