Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое PATH
  PATH, a phone-delivered positive psychology intervention for patients who have undergone HSCT, consists of three 3-week modules. The first module focuses on gratitude and physical activity goal setting. The second module focuses on personal strengths and resources to enhance daily physical activity. The third module focuses on meaning and assessing barriers to physical activity. The third week of each module is an integration exercise dedicated to help participants explore practical ways of inco

Первичные конечные точки

• Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale [Срок оценки: 10 weeks]

Вторичные конечные точки (6)

• Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale [Срок оценки: Up to 40 weeks]
• Depression Symptoms based on the Hospital Anxiety and Depression Scale-Depression Subscale [Срок оценки: Up to 40 weeks]
• Gratitude based on the Gratitude Questionnaire [Срок оценки: Up to 40 weeks]
• Positive Affect based on the Positive and Negative Affect Schedule Positive Affect Subscale [Срок оценки: Up to 40 weeks]
• Physical function based on the Patient-Reported Outcomes Measurement Information System-Physical Function-20 [Срок оценки: Up to 40 weeks]
• Patient-Reported Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) [Срок оценки: Up to 40 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 3 центра

• Moffitt Cancer Center — Tampa
• Dana Farber Cancer Institute — Boston
• Duke Cancer Institute — Durham

Идентификаторы

NCT: NCT06328127 · 23-691

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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