Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • PATH

    Behavioral

    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 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

400 Participants
are divided into 2 treatment groups
Group A: Positive Affect in the Transplantation of Hematopoietic Stem Cells (PATH)Experimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
10 weeks

Secondary outcomes

1

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.

Time frame
Up to 40 weeks
2

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.

Time frame
Up to 40 weeks
3

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.

Time frame
Up to 40 weeks
4

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.

Time frame
Up to 40 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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