Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 6
- 主要终点
- Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale
研究概览
简要总结
This randomized clinical trial is evaluating the impact of a positive psychology intervention (PATH) on anxiety symptoms, depression symptoms, and quality of life in survivors of hematopoietic stem cell transplant (HSCT) compared to usual care.
详细描述
Patients undergoing hematopoietic stem cell transplantation (HSCT) deal with numerous physical and psychological symptoms during acute hospitalization and recovery. Of the few psychosocial interventions tailored to the needs of the HSCT population, most focus on the needs of patients in the pre-transplant phase or during the HSCT hospitalization, but not during the acute recovery period starting at 100-days post-HSCT. Hence, the investigators developed a remotely-delivered positive psychology intervention, Positive Affect in the Transplantation of Hematopoietic Stem Cells (PATH). This intervention encourages patients to perform simple and enjoyable structured activities that increase the intensity of positive thoughts and emotions. With this multi-site randomized clinical trial, the investigators aim to find out whether PATH can improve psychological distress and quality of life in HSCT survivors, compared to usual care, using validated assessment tools.
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
- 否
入选标准
- •Adult patients (aged 18 years and older) undergoing allogeneic HSCT and are approaching 100-days post-HSCT
- •Ability to speak, read, and respond to questions in English or Spanish to complete study procedures
- •Access to a basic telephone
排除标准
- •Patients who underwent allogeneic HSCT for benign hematologic conditions
- •Patients with severe psychiatric or cognitive conditions, such as dementia, determined by their transplant oncologist to make them unable to provide informed consent or comply with study procedures
研究组 & 干预措施
Positive Affect in the Transplantation of Hematopoietic Stem Cells (PATH)
Participants recruited from the Dana-Farber Cancer Institute, Duke Cancer Institute, and Moffitt Cancer Center who are randomized to the intervention/experimental arm will receive the PATH intervention, which is focused on gratitude, strengths, and meaning, as well as focused exercises on goal-setting and tracking daily physical activity.
Participants will complete questionnaires (in person, over the computer or telephone, or by mail) at predetermined days per protocol.
干预措施: PATH (Behavioral)
Usual Care
Participants recruited from the Dana-Farber Cancer Institute, Duke Cancer Institute, and Moffitt Cancer Center who are randomized to the usual care arm will receive their usual support from the HSCT team, including all routine supportive care resources (e.g., support from social work) offered by the HSCT team.
Participants will complete questionnaires (in person, over the computer or telephone, or by mail) at predetermined days per protocol.
结局指标
主要结局
Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale
时间窗: 10 weeks
Compare anxiety symptoms between the two groups at 10 weeks using the 7-item Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A). The HADS-A subscale ranges from 0-21, with higher scores indicating worse anxiety symptoms.
次要结局
- Positive Affect based on the Positive and Negative Affect Schedule Positive Affect Subscale(Up to 40 weeks)
- Patient-Reported Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)(Up to 40 weeks)
- Depression Symptoms based on the Hospital Anxiety and Depression Scale-Depression Subscale(Up to 40 weeks)
- Gratitude based on the Gratitude Questionnaire(Up to 40 weeks)
- Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale(Up to 40 weeks)
- Physical function based on the Patient-Reported Outcomes Measurement Information System-Physical Function-20(Up to 40 weeks)
研究者
Hermioni L.Amonoo, MD, MPP, MPH
Director, Well-Being and Cancer Research Program
Brigham and Women's Hospital