Improved Behavioral Outcome in Allogeneic Hematopoietic Stem Cell Transplant Patients by Reducing Caregiver Distress: Behavioral and Physiological Evidence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 4
- 主要终点
- Functional Assessment of Cancer Treatment - Blood/Marrow Transplant
研究概览
简要总结
PURPOSE: As this is a randomized controlled trial, all subjects receiving stress management psychoeducation will be expected to obtain a new set of coping skills that will allow them to better deal with the stressors of caregiving for an allogeneic HSCT patient. It is expected that improving caregiver status will improve patient quality of life.
详细描述
Specific Aims
- Create a Community Advisory Board (CAB) consisting of allogeneic HSCT patients, caregivers, blood cancer oncologists, support staff and study investigators to provide input.
- Assess patient Quality of Life (QOL) following an allogeneic HSCT using the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) as the primary patient outcome. Patients whose caregivers receive "fone" PsychoEducation and Relaxation (fPER) will have improved QOL compared to caregivers assigned to treatment as usual (TAU).
- Test the impact of fPER on a caregiver composite distress score (encompasses depression, anxiety, and stress) as the primary caregiver outcome. Caregivers receiving fPER will have reduced distress.
- Assess biomarkers of allostatic load in patients prior to transplant and caregivers during the transplant process using novel biomarkers (hair cortisol and telomeres). fPER will be associated with reduced allostatic load in caregivers compared to TAU. Patient hair cortisol collected only before transplant will relate to QOL at intake.
OUTLINE: Caregivers are randomized to 1 of 2 groups.
All patients and caregivers, regardless of randomization, are informed of what to expect during the transplant process and how to locate available support resources within each program. Patients and caregivers are given information that is specific to their involvement in the transplantation process and recovery phase.
- Group I (treatment as usual [TAU]): Subjects randomized to TAU will be encouraged to participate in available support programs at their respective centers which are very similar between sites and include individual counseling as well as support groups. Due to the impact of our prior intervention on caregiver distress, we will provide each caregiver randomized to TAU a workbook prepared for someone to use without inclusion of one-on-one sessions with a therapist.
- Group II (PsychoEducation and Relaxation [fPER]): Caregivers will participate in the fPER intervention prior to transplant. The fPER consists of 10 sessions to include 4 weekly 60-minute sessions followed by 4 biweekly 60-minute sessions and two additional sessions between day 100 and 6 months post-transplant. Each fPER session will be devoted to a separate topic with the goal of assisting the caregiver in the development and application of stress-management coping skills including learning problem-solving skills, identifying cognitive distortions, application of relaxation techniques, use of the emWave2, coping skills training, effective use of social support, and establishing appropriate goals. All caregivers in fPER will be provided a Caregiver Workbook that includes information about the session topics and homework assignments. fPER sessions will be delivered either at the clinic during patient visits or via video chat. fPER will also include incorporation of Smartphone technology to make the interventionist available by video chat.
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 85 Years（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 hematopoietic stem cell transplant (HSCT)
- •Caregiver: the person in the patient's life who is primarily responsible for care decisions, emotionally invested in the patient's care, provides instrumental care such as transportation, and available if randomized to the fPER group to participate in the majority of intervention sessions
- •PATIENT CHARACTERISTICS:
- •Able to read and speak English
- •Has telephone access
- •CAREGIVER CHARACTERISTICS:
- •Able to read and speak English
- •Willingness to use a Smartphone
- •No serious medical condition likely to influence cortisol assessment in their hair
- •Alcohol consumption limited to < 2 drinks/day
- •At least 18 years of age
排除标准
- •PRIOR CONCURRENT THERAPY:
- •No history of a psychiatric illness unrelated to the HSCT within the past 18 months
- •No steroid medications (caregiver)
结局指标
主要结局
Functional Assessment of Cancer Treatment - Blood/Marrow Transplant
时间窗: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant
"Functional Assessment of Cancer Treatment - Blood/Marrow Transplant" (FACT-BMT) is used to assess the life quality of patients. The scale includes 5 subscales. The scores of each scale are summed to compute a total score. The scale range is 0-148. Higher score indicates better life quality.
Caregiver Distress - Principal Component Analysis
时间窗: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant
Caregiver Distress is a composite score is created from a principal component analysis (PCA). This PCA extracted the first principal component from summary variables of Center for Epidemiological Studies Depression Scale, Spielberger State and Trait Anxiety Inventory, and Perceived Stress Scale. The composite distress score has a mean of 0.0 and SD of 1.0, scale ranges from -2.06 - 3.73. Higher score indicates greater distress.
次要结局
- Change in Adrenal Activity Over Time(Baseline (prior to transplant), 3 months (caregiver only), and 6 months after transplant.)
- Caregiver Reaction Assessment(Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant)
- Change in Caregiver Telomerase Activity Over Time(Baseline (prior to transplant), 3 months and 6 months after transplant)
- Center for Epidemiological Studies Depression Scale(Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant)
- Change in Caregiver Telomere Length Over Time(Baseline (prior to transplant), 3 months and 6 months after transplant)
- Perceived Stress Scale(Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant)
- Spielberger State-Trait Anxiety Inventory(Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant)