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NCT Number: NCT06328127

Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors

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.

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Key information

Conditions

Hematopoietic Stem Cell Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center, Tampa, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale

    Time frame: 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.

Secondary outcomes

  1. Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale

    Time frame: Up to 40 weeks

    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.

  2. Depression Symptoms based on the Hospital Anxiety and Depression Scale-Depression Subscale

    Time frame: Up to 40 weeks

    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.

  3. Gratitude based on the Gratitude Questionnaire

    Time frame: Up to 40 weeks

    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.

  4. Positive Affect based on the Positive and Negative Affect Schedule Positive Affect Subscale

    Time frame: Up to 40 weeks

    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.

  5. Physical function based on the Patient-Reported Outcomes Measurement Information System-Physical Function-20

    Time frame: Up to 40 weeks

    Compare physical function longitudinally between the two groups using the 20-item Patient-Reported Outcomes Measurement Information System-Physical Function-20 (PROMIS-PF-20).

    The PROMIS-PF-20 ranges from 20 to 100, with higher scores indicating better physical functioning.

  6. Patient-Reported Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)

    Time frame: Up to 40 weeks

    Compare quality of life longitudinally between the two groups using the 47-item Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT).

    The FACT-BMT consists of 5 subscales assessing well-being across the following domains: physical, functional, emotional, social, and bone marrow transplant symptoms. The FACT-BMT ranges from 0-148, with higher scores indicating better quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Hermioni Amonoo, MD, MPP, MPH

CONTACT

[email protected]

617-525-7472

Isabella Larizza, BSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Dana-Farber Cancer Institute
  • Duke University
  • H. Lee Moffitt Cancer Center and Research Institute

Registry information

Acronym: PATH-4

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Mar 25, 2024
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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