About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
PATH
BehavioralPATH, 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 incorporating the themes for the given module into daily life. A trained interventionist will guide participants to complete each 30-minute weekly session.
Treatment groups
Trial outcomes
Primary outcomes
Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale
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.
Secondary outcomes
Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale
Compare anxiety symptoms longitudinally between the two groups using the 7-item Hospital Anxiety and Depression Scale-Anxiety (HADS-A) subscale. The HADS-A subscale ranges from 0-21, with higher scores indicating worse anxiety symptoms.
Depression Symptoms based on the Hospital Anxiety and Depression Scale-Depression Subscale
Compare depression symptoms longitudinally between the two groups using the 7-item Hospital Anxiety and Depression Scale-Depression (HADS-D) subscale. The HADS-D subscale ranges from 0-21, with higher scores indicating worse depression symptoms.
Gratitude based on the Gratitude Questionnaire
Compare gratitude longitudinally between the two groups using the 6-item Gratitude Questionnaire. The Gratitude Questionnaire ranges from 6-42, with higher scores indicating a stronger propensity for experiencing gratitude in daily life.
Positive Affect based on the Positive and Negative Affect Schedule Positive Affect Subscale
Compare positive affect longitudinally between the two groups using the 10-item Positive and Negative Affect Schedule (PANAS) Positive Affect Subscale. The PANAS Positive Affect Subscale ranges from 10-50, with higher scores indicating higher levels of positive affect.
Sponsors and contacts
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Brigham and Women's Hospital
Lead sponsor
Dana-Farber Cancer Institute
Collaborator
Duke University
Collaborator
H. Lee Moffitt Cancer Center and Research Institute
Collaborator
National Cancer Institute (NCI)
Collaborator