Psychoeducation For BMT Caregivers: Biobehavioral Markers and Outcome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 298
- 试验地点
- 4
- 主要终点
- Physiological - Cortisol Awakening Response (CAR)
研究概览
简要总结
RATIONALE: A stress management intervention may be more effective than usual care in improving quality of life in caregivers of patients undergoing bone marrow transplant.
PURPOSE: This randomized phase III trial is studying a stress management intervention for caregivers of patients undergoing bone marrow transplant.
详细描述
Specific Aims
- Further validate a unique saliva collection device in a randomized controlled study of a psychoeducation, paced respiration, and relaxation (PEPRR) intervention for caregivers of patients undergoing bone marrow transplantation.
- Evaluate the suitability of paced respiratory training using RESPeRATE™ for these caregivers.
- Determine the efficacy of a PEPRR intervention on behavioral (stress level, mood and overall health) and physiological (neuroendocrine function, immune function, and sleep) outcomes of these caregivers.
OUTLINE: Caregivers are randomized to 1 of 2 groups.
- Group I (treatment as usual [TAU]): Caregivers and patients attend a 2-hour orientation class that provides an overview of the transplant process, information regarding financial issues and resources that may be available to the patient and caregiver, a review of caregiver duties, dietary restrictions post-transplantation, a brief introduction to stress and stress management, and hands-on training of how to care for a central venous catheter. Patients also receive information in the form of a written manual that provides in-depth information about transplant, including how the transplant works, what to expect, caregiver duties, graft-vs-host disease, and when to contact medical staff for assistance. A voluntary 1-hour weekly caregiver support group is offered on the inpatient BMT unit.
- Group II (psychoeducation, paced respiration, and relaxation [PEPRR]): Caregivers and patients attend a 2-hour orientation class identical to group I. Caregivers also participate in the PEPRR intervention comprising an individualized stress management component and educational component that addresses the psychosocial needs of the caregivers. It also provides self-care and adaptive coping skills. The stress management component addresses caregivers' perception of potential stressors (primary appraisal); perceived ability to control or manage the stressor (secondary appraisal); ability to exert control and cope with the stressor (coping effort); and ongoing evaluation of the stressor and their perceived ability of managing the stressor (reappraisal) and applies coping strategies such as relaxation, prioritizing, goal setting, pacing, and communicating needs. The PEPRR intervention consists of 8 sessions (4 weekly 60-minute sessions followed by 4 biweekly 60-minute sessions) that cover the 100-day period of caregiving post-transplantation. Caregivers also undergo paced respiratory (RESPeRATE™) training for 15 minutes once daily over 12 weeks that measures caregiver adherence and compliance to the relaxation program.
Caregivers and patients undergo psychosocial assessments at approximately 1-3 months prior to randomization and transplantation and again at 1, 3, 6, and 12 months after transplantation. Caregivers also complete questionnaires to assess their stress (PSS, CRA, and IES), mood (POMS, CES-D, and STAI), sleep (PSQI), and health (SF-36).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •DISEASE CHARACTERISTICS (Meets all of the following criteria):
- •Patient undergoing allogeneic bone marrow transplantation (BMt)
- •Primary caregiver of a BMT patient
- •Has provided care for the patient for at least 50 days of the required 100 days of caregiving following transplant (e.g., 50% of the total time)
- •PATIENT CHARACTERISTICS:
- •Able to read and speak English
- •Has telephone access
- •No serious medical condition likely to influence immune and neuroendocrine parameters (caregiver)
- •Alcohol consumption limited to < 2 drinks/day (caregiver)
- •No history of a psychiatric illness unrelated to the experience as a caregiver within the past 18 months (caregiver)
- •No history of a psychiatric illness unrelated to the BMT within the past 18 months (patient)
排除标准
- •PRIOR CONCURRENT THERAPY:
- •No concurrent steroid medications (caregiver)
结局指标
主要结局
Physiological - Cortisol Awakening Response (CAR)
时间窗: Baseline (prior to transplant), 1 and 3 post transplant
Saliva will be collected using SPIT booklets containing four separate filter papers corresponding to collection times separated by waxed paper. Subjects will be asked to moisten a filter paper 1) immediately after waking, 2) 30 min later, 3) before lunch and 4) 10 hours after waking. They will be asked to collect these samples on three days typical for their schedules at each phase of the. They will indicate the time of each collection. Filters will dry in the booklet. Saliva samples will be aggregated across the three sampling days at each study phase to better reflect the typical pattern for each subject (see Smyth et al, 1997). The change from awakening to 30 minutes in cortisol (CAR) will be characterized by the change between waking and 30 min.
Behavioral - Stress Level as Measured by the Perceived Stress Scale (PSS)
时间窗: Baseline (prior to transplant), 1 and 3 post transplant
The Perceived Stress Scale (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. Minimum score (best value)=0. Maximum score (worst value)=56. A higher score indicates greater stress.
次要结局
- Physical Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36P)(Baseline (prior to transplant), 1 and 3 post transplant)
- Area Under the Curve for Salivary Cortisol (AUCc)(Baseline (prior to transplant), 1 and 3 post transplant)
- Plasma Inflammatory Marker Interleukin 10 (IL-10)(Baseline (prior to transplant) and 3 post transplant)
- Depression Measured by the Center for Epidemiological Studies Depression Scale (CESD)(Baseline (prior to transplant), 1 and 3 post transplant)
- Stress as Measured by Caregiver Burden Using the Caregiver Reaction Assessment (CRA)(Baseline (prior to transplant), 1 and 3 post transplant)
- Sleep as Assessed by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score(Baseline (prior to transplant), 1 and 3 post transplant)
- Mental Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36M)(Baseline (prior to transplant), 1 and 3 post transplant)
- Host Defense Assessed by Natural Killer (NK) Cell Cytotoxicity(Baseline (prior to transplant), 1 and 3 post transplant)
- Plasma Inflammatory Marker Tumor Necrosis Factor (TNF)(Baseline (prior to transplant) and 3 post transplant)
- State Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI)(Baseline (prior to transplant), 1 and 3 post transplant)
- Total Mood Disturbance (TMD) Score Using the Profile of Mood States (POMS)(Baseline (prior to transplant), 1 and 3 post transplant)
- Stress as Measured by the Impact of Events Scale (IES)(Baseline (prior to transplant), 1 and 3 post transplant)
- Plasma Inflammatory Marker Interleukin 6 (IL-6)(Baseline (prior to transplant) and 3 post transplant)
- The Slope of the Diurnal Decline (SlopeD) in Salivary Dehydroepiandrosterone (DHEA)(Baseline (prior to transplant), 1 and 3 post transplant)
- Area Under the Curve for Salivary DHEA (AUCd)(Baseline (prior to transplant), 1 and 3 post transplant)
- Plasma Inflammatory Marker Interleukin 1 Beta (IL-1 Beta)(Baseline (prior to transplant) and 3 post transplant)
- The Slope of the Diurnal Decline in Salivary Cortisol (SlopeC)(Baseline (prior to transplant), 1 and 3 post transplant)
- Plasma C-reactive Protein (CRP)(Baseline (prior to transplant) and 3 post transplant)
- Plasma Inflammatory Marker Interleukin 4 (IL-4)(Baseline (prior to transplant) and 3 post transplant)