Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors

Part of paid clinical trials in Tampa, Florida.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06328127
Status
Recruiting
Apply to this trial

Conditions

  • Hematopoietic Stem Cell Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Dec 17, 2024
Status verified
Nov 2025
Primary completion
May 31, 2029
Completion
May 31, 2030

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.
  • No Intervention: 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.

Primary Outcome Measure

Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale [ Time Frame: 10 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Heather Jim, PhD
[email protected]
Dana Farber Cancer InstituteBostonMassachusetts02215
Hermioni Amonoo, MD, MPP, MPH
[email protected]
617-525-7472
Hermioni Amonoo, MD, MPP, MPH (PRINCIPAL_INVESTIGATOR)
Duke Cancer InstituteDurhamNorth Carolina27710
Thomas LeBlanc, MD
[email protected]

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Moffitt Cancer Center· Tampa, FLDana Farber Cancer Institute· Boston, MADuke Cancer Institute· Durham, NC

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