Randomized Trial of a Positive Psychology Intervention for Patients With Hematologic Malignancies Undergoing Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Feasibility Rate
研究概览
简要总结
The main purpose of this research study is to determine if a positive psychology-based program in people who have received a stem cell transplant for blood cancer treatment is feasible and acceptable, and can help improve positive feelings, mood, quality of life, overall wellbeing and health.
The Positive psychology for Allogenic Transplantation of Hematopoietic stem cell intervention (PATH), a novel 9-week phone-administered Positive psychological intervention (PPI).
详细描述
Low levels of positive psychological well-being (PPWB) (e.g., optimism, positive affect) in allogeneic hematopoietic stem cell transplant (HSCT) recipients are common and have been associated with decreased quality of life, poorer immune response, and increased mortality. These poor health outcomes are likely mediated through deficits in health behaviors (e.g., medication adherence, physical activity), and indeed low PPWB has been prospectively associated with poorer adherence to diet, medication, and physical activity in other medical populations, independent of sociodemographic, medical comorbidity, and the ill effects of depression and anxiety. Positive psychological interventions (PPIs) could be used to promote PPWB in the allogeneic transplant population. Despite the successful and effective use of PPIs in medical populations to reduce distress, increase quality of life, and promote health behaviors, PPI have never been tested in allogeneic recipients.
-This a single center randomized trial of the PATH intervention versus usual care in patients with hematologic malignancies undergoing HSCT.
The research study procedures include screening for eligibility:
-
Participants will be randomized equally to the two arms using randomized permuted blocks of sizes two and four, with randomization stratified by presence/absence of graft-versus-host disease (GVHD), as allogeneic transplant recipients with GVHD have significantly different courses of recovery, QOL, and function post transplant.
-
Participant will be randomized into either: The Positive psychology for Allogenic Transplantation of Hematopoietic stem cell intervention (PATH), a novel 9-week phone-administered Positive psychological intervention (PPI) or usual care.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥ 18 years) with hematologic malignancies who have received allogeneic HSCT at Dana Farber Cancer Institute who are approaching 100-day post-transplant milestone.
- •Ability to speak, read and write English.
- •Access to a telephone.
排除标准
- •Cognitive deficits impeding a study participant's ability to provide informed consent or participate adequately in the study procedures assessed via a commonly used 6-item cognitive assessment with the Brief Interview for Mental Status (BIMS).
- •Medical conditions precluding interviews.
- •Patients undergoing HSCT for benign hematologic conditions.
- •Patients undergoing outpatient HSCT.
- •Patients with psychiatric or cognitive conditions which the treating clinicians believes prohibits compliance with study procedures.
- •Patients who are unable to verbally consent or are not yet adults (including infants, children, teenagers), pregnant women, or prisoners.
研究组 & 干预措施
PATH Intervention
Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment.
At approximately 100-days post-HSCT, participants will begin an 9-week positive psychology program involving weekly calls with an interventionist and exercises (i.e., writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).
-Self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.
干预措施: Positive Psychology Intervention (Behavioral)
Usual Care Control
Participants in the Usual Care Control arm will receive regular social work assessments as part of HSCT recovery and work does not focus on PPWB skill building or cognitive strategies.
结局指标
主要结局
Feasibility Rate
时间窗: 9 weeks
Feasibility was defined a \>75% of enrolled participants in the PATH group completing at least 6 of the 9 positive psychology sessions.
次要结局
- Mean Quality of Life Scores(At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration)
- Acceptability Rate(9 weeks)
研究者
Hermioni L.Amonoo, MD, MPP, MPH
Physician
Brigham and Women's Hospital