A Proof-of-Concept Trial of a Positive Psychology Intervention for Allogeneic Stem Cell Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Feasibility of Positive Psychology (PP) Intervention
研究概览
简要总结
The goal of this research study is to find out if a novel phone-based positive psychology intervention that focuses on improving health behaviors and positive emotions can help improve mood, health related quality of life, and overall function in patients who have just undergone hematopoietic stem cell transplantation as part of blood cancer treatment.
详细描述
Hematopoietic stem cell transplantation (HSCT) is a rigorous treatment for blood cancer patients that can be life-saving, but often causes psychological distress. The investigators hope that this study will help the research team to develop and implement a positive psychological intervention designed to help HSCT patients increase positive emotions such as hope, gratitude, and fulfillment while recovering from a stem cell transplant. Participants will be selected after receiving an allogeneic hematopoietic stem cell transplant treatment in the past 30 days at the Dana-Farber Cancer Institute (DFCI).
In this project, the investigators hope to:
- Test the feasibility and acceptability of a novel, 8-week, phone-based positive psychology intervention in a small cohort of post-HSCT patients (N = 30).
- Explore potential benefits of completing the intervention on outcomes of interest, such as positive affect and overall function.
Baseline information about enrolled participants will be obtained from patients from the electronic medical record as required for characterization of our population. This information will include data regarding medical history, current medical variables, medications, and sociodemographic data.
Participants will be approached upon nearing their discharge from the hospital, approximately 30 days after their transplant. Between the time of their discharge and their 100-day post-transplant visit, there will be three check-in/psychosocial support phone calls at weeks 4, 8, and 12 after discharge to build rapport and discuss their recovery. Then, at week 14, participants will meet with the principal investigator to complete self-assessment questionnaires. The participants will then complete an 8-week phone-based positive psychology intervention, at the end of which the self-assessment questionnaires will be repeated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 with hematologic malignancies hospitalized for allogeneic HSCT at the DFCI inpatient units who are medically stable and appropriate for study approach
- •Ability to speak, read and write English
- •Access to a telephone
排除标准
- •Current major depressive episode, bipolar disorder, psychosis or active substance use disorder diagnosed via the Mini International Neuropsychiatric Interview (MINI)
- •Cognitive deficits impeding a study participant's ability to provide informed consent or participate adequately in the study assessed via the Brief Interview for Mental Status (BIMS)
- •Medical conditions precluding interviews
研究组 & 干预措施
Positive Psychology
Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.
At approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).
Participants will complete 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)
结局指标
主要结局
Feasibility of Positive Psychology (PP) Intervention
时间窗: Baseline - week 8 of intervention
Feasibility will be measured by examining the number of completed exercises.
Acceptability of Exercises: Ease Score
时间窗: Baseline - week 8 of intervention
Participants will provide ratings of ease of completion after each PP exercise, measured on a 10-point Likert scale (score range: 0-10, 0 = very difficult and 10 = very easy). Ratings from all 8 weeks were averaged.
Acceptability of Exercises: Utility Score
时间窗: Baseline - week 8 of intervention
Participants will provide ratings of utility of completion after each PP exercise, measured on a 10-point Likert scale (score range: 0-10, 0 = not helpful and 10 = very helpful). Ratings from all 8 weeks were averaged.
次要结局
- Changes in HADS Scores(Change in score from baseline to 8 weeks)
- Changes in PROMIS-PF-20 Scores(Change in score from baseline to 8 weeks)
- Changes in LOT-R Scores(Change in score from baseline to 8 weeks)
- Immediate Impact of Exercises: Positive Affect Score(Week 1 of intervention - Week 8 of intervention)
- Changes in PANAS Scores(Change in score from baseline to 8 weeks)
- Changes in FACT-BMT Scores(Change in score from baseline to 8 weeks)
- Immediate Impact of Exercises: Optimism Score(Week 1 of intervention - Week 8 of intervention)
研究者
Hermioni L.Amonoo, MD, MPP, MPH
Director, Well-Being and Cancer Research Program
Brigham and Women's Hospital