Hematopoietic Stem Cell TransplantPATH-4NCT06328127
Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors
A study testing PATH in people with Hematopoietic Stem Cell Transplant, run by Brigham and Women's Hospital at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplant
- What is being tested?
- PATH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Dec 2024to 31 May 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Isabella Larizza, BSc contact
United States3 sites, 3 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Hermioni Amonoo, MD, MPP, MPH, 617-525-7472, Hermioni_Amonoo@dfci.harvard.edu
Hermioni Amonoo, MD, MPP, MPH
- Recruiting
Duke Cancer Institute
Durham, North Carolina, 27710
Thomas LeBlanc, MD, thomas.leblanc@duke.edu
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Heather Jim, PhD, heather.jim@moffitt.org
About this study
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.
Read the detailed description
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.
- Conditions
- Hematopoietic Stem Cell Transplant
- Being tested
- PATH
- Keywords
- stem cell transplant, positive psychology intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PATHBehavioural
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 group | Role | What they receive |
|---|---|---|
| Positive Affect in the Transplantation of Hematopoietic Stem Cells (PATH) | Experimental | 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. Receives: Behavioral: PATH |
| Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (6)
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.
Measured: Up to 40 weeks
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.
Measured: Up to 40 weeks
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.
Measured: Up to 40 weeks
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.
Measured: Up to 40 weeks
Physical function based on the Patient-Reported Outcomes Measurement Information System-Physical Function-20
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.
Measured: Up to 40 weeks
Patient-Reported Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)
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.
Measured: Up to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start17 Dec 2024
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Duke University, H. Lee Moffitt Cancer Center and Research Institute, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Hermioni L.Amonoo, MD, MPP, MPH, Brigham and Women's Hospital
- Investigators
- Hermioni Amonoo, MD, MPP, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328127
- Sponsor's protocol ID
- 23-691
- Other IDs
- R37CA288557
- Acronym
- PATH-4
- Status last verified
- Sep 2026
- First submitted
- 11 Mar 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber/Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor, Investigator, or designee. The protocol and statistical analysis plan will be made available on ClinicalTrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.