Hematologic MalignancyPATH-CNCT06153797
A Positive Psychology Based Intervention (PATH-C) for Caregivers of HSCT Survivors
A study testing PATH-C in people with Hematologic Malignancy and Caregiver, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The goal of this randomized clinical trial is to evaluate whether a positive psychology intervention (PATH-C) can improve psychological well-being, quality of life, and physical activity in caregivers of patients undergoing hematopoietic stem cell transplantation (HSCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy, Caregiver
- What is being tested?
- PATH-C
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 caregivers (aged 18 years and older) of patients undergoing allogeneic or autologous HSCT at Dana-Farber Cancer Institute for a hematologic malignancy.
- A relative or a friend who either lives with the patient or has in-person contact with them at least twice per week and is identified as the primary caregiver for HSCT.
- Ability to speak English and able to complete questionnaires with minimal assistance of an interpreter as this is a feasibility trial of the PATH-C intervention which is currently only available in English.
Who cannot join
- Caregivers of patients undergoing HSCT for benign hematologic conditions.
- Caregivers with acute or unstable psychiatric conditions which the treating transplant clinician believes prohibits informed consent or compliance with study procedures.
- Cognitive deficits impeding a caregiver's ability to provide informed consent or participate adequately in the study assessed via a commonly used 6-item cognitive assessment with the Brief Interview for Mental Status (BIMS) screening tool that is sensitive and specific for screening for cognitive impairment in research participants.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Randomized Controlled Trial of a Positive Psychology Based Intervention (PATH-C) for Caregivers of Hematopoietic Stem Cell Transplant Survivors
The goal of this randomized clinical trial is to evaluate whether a positive psychology intervention (PATH-C) can improve psychological well-being, quality of life, and physical activity in caregivers of patients undergoing hematopoietic stem cell transplantation (HSCT).
Read the detailed description
Family and friend caregivers are vital care providers throughout the entire care continuum for patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT). These caregivers must manage multiple time-consuming responsibilities, including monitoring vital signs and side effects of treatment, administering medications, and coordinating transportation to and from medical appointments. The substantial caregiving burden among caregivers of patients undergoing HSCT is associated with increased symptoms of depression, anxiety, and fatigue. Symptoms such as fatigue and depression in HSCT caregivers may undermine attempts to maintain regular physical activity routines, which may impact essential health outcomes such as cardiovascular health.
With persistent shortages in the mental health workforce needed to address these psychological needs of HSCT caregivers adequately, remotely-delivered psychosocial interventions offer an innovative approach to overcome the unmet psychological needs of this population. Hence, the investigators developed a remotely-delivered positive psychology intervention, Positive Affect in the Transplantation of Hematopoietic Stem Cells for Caregivers (PATH-C), tailored to the unique psychological needs of HSCT caregivers. With this study, the investigators will establish the impact of PATH-C on participant-reported outcomes compared to usual care.
The study will use validated questionnaires to measure caregivers' quality of life, caregiver burden, psychological distress symptoms, positive psychological well-being (e.g., positive affect, gratitude), and self-management targets (e.g., coping, self-efficacy). The study will also use the validated ActiGraph GT3X+ accelerometer to measure minutes/day of moderate-to-vigorous physical activity, light activity, and sedentary leisure time.
- Conditions
- Hematologic Malignancy, Caregiver
- Being tested
- PATH-C
- Keywords
- Hematologic Malignancy, Hematopoietic Stem Cell Transplant, Caregivers of Patients with Cancer, Positive Psychology Intervention
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PATH-CBehavioural
PATH-C, a phone-delivered positive psychology intervention for caregivers of patients undergoing HSCT, consists of the following nine sessions: 1) Enhancing gratitude and increasing awareness for physical activity; 2) Expressing gratitude and goal setting for physical activity; 3) Integrating gratitude and goals for physical activity; 4) Personal strengths and environmental scan to enhance physical activity; 5) Enhancing strengths via reflection on past successes; 6) Integrating strengths to enhance well-being and physical activity; 7) Engaging in enjoyable and meaningful activities; 8) Promoting optimism and integrating long-term activity habits; 9) Integrating meaning for sustainable physical activity goals. Each session takes about 30 minutes, and a trained interventionist will guide participants to complete the sessions.
| Study group | Role | What they receive |
|---|---|---|
| PATH-C | Experimental | Participants will be recruited from the Dana-Farber Cancer Institute and randomized in a 1:1 fashion, stratified by transplant type (autologous versus allogeneic), to PATH-C versus usual care.
Caregivers of patients undergoing HSCT will receive the PATH-C intervention to learn to reflect on their positive emotions and consistently use and incorporate positive psychology exercises in their daily routine, as well as learn how to set goals and track their physical activity (i.e., with an activity tracker) daily while caring for a loved one undergoing HSCT.
Participants will complete questionnaires (in person, over the computer or telephone, or by mail) at predetermined days per protocol. Receives: Behavioral: PATH-C |
| Usual Care | No intervention | Participants will be recruited from the Dana-Farber Cancer Institute and randomized in a 1:1 fashion, stratified by transplant type (autologous versus allogeneic), to PATH-C versus usual care. Participants will complete questionnaires (in person, over the computer or telephone, or by mail) at predetermined days per protocol. Participants in the usual care arm will receive their usual support from the HSCT team as caregivers of patients undergoing HSCT, including all routine supportive care resources (e.g., support from social work) offered by the HSCT team. Patients in the usual care and PATH-C groups will be permitted to use all supportive care services per standard care. The investigators will track referrals to supportive care services in both groups by reviewing the Electronic Health Record (EHR). |
What is being measured
The primary outcome is the main question the study is designed to answer.
PATH-C Intervention Feasibility
PATH-C Intervention Feasibility is defined as >60% of eligible participants enrolling in the study and >60% of enrolled participants who start the intervention completing at least 6/9 intervention sessions.
Measured: Up to 10 weeks
Secondary outcomes (6)
PATH-C Intervention Acceptability
Acceptability will be measured using weekly ratings of the ease and utility of each exercise (0=very difficult/not helpful; 10=very easy/very helpful) and will use a threshold of a mean combined score of 7.0/10.0.
Measured: Up to 10 weeks
Physical activity longitudinally based on ActiGraph GT3X+ accelerometer
Compare physical activity levels using the ActiGraph GT3X+ accelerometer between the two groups.
Greater steps/day and lower sedentary leisure time indicate greater physical activity.
Measured: Up to 20 weeks (+/- 28 days)
Caregiver Quality of Life based on the CarGOQOL
Compare caregiver quality of life using the 29-item CareGiver Oncology Quality of Life questionnaire (CarGOQOL) between the two groups.
Higher scores on the CarGOQOL (normalized score range, 1-100) indicate better quality of life.
Measured: Up to 20 weeks (+/- 28 days)
Anxiety Symptoms based on the HADS-Anxiety Subscale
Compare anxiety symptoms using the 7-item Hospital Anxiety and Depression Scale-Anxiety (HADS-A) subscale between the two groups.
The HADS-A subscale ranges from 0-21, with higher scores indicating worse anxiety symptoms.
Measured: Up to 20 weeks (+/- 28 days)
Depression Symptoms based on the HADS-Depression Subscale
Compare depression symptoms using the 7-item Hospital Anxiety and Depression Scale-Depression (HADS-D) subscale between the two groups.
The HADS-D subscale ranges from 0-21, with higher scores indicating worse depression symptoms.
Measured: Up to 20 weeks (+/- 28 days)
Caregiving Burden based not the Caregiver Reaction Assessment (CRA)
Compare caregiving burden using the 24-item Caregiver Reaction Assessment (CRA) between the two groups.
The CRA ranges from 24 to 120, with higher scores indicating greater caregiving burden.
Measured: Up to 20 weeks (+/- 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start1 Jan 2024
- Primary completion17 Nov 2025
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Robert Wood Johnson Foundation, American Society of Hematology
- 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
- NCT06153797
- Sponsor's protocol ID
- 23-509
- Acronym
- PATH-C
- Status last verified
- Feb 2026
- First submitted
- 23 Nov 2023
- Last updated
- 6 Feb 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 the 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Positive Psychology Based Intervention (PATH-C) for Caregivers of Hematopoietic Stem Cell Transplant Survivors
- ClinicalTrials.gov ID
- NCT06153797
- Acronym / sponsor ID
- PATH-C / 23-509
- Conditions
- Hematologic Malignancy, Caregiver
- Keywords
- Hematologic Malignancy, Hematopoietic Stem Cell Transplant, Caregivers of Patients with Cancer, Positive Psychology Intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Robert Wood Johnson Foundation, American Society of Hematology
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 17 Nov 2025 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized clinical trial is to evaluate whether a positive psychology intervention (PATH-C) can improve psychological well-being, quality of life, and physical activity in caregivers of patients undergoing hematopoietic stem cell transplantation (HSCT).
Detailed description
Family and friend caregivers are vital care providers throughout the entire care continuum for patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT). These caregivers must manage multiple time-consuming responsibilities, including monitoring vital signs and side effects of treatment, administering medications, and coordinating transportation to and from medical appointments. The substantial caregiving burden among caregivers of patients undergoing HSCT is associated with increased symptoms of depression, anxiety, and fatigue. Symptoms such as fatigue and depression in HSCT caregivers may undermine attempts to maintain regular physical activity routines, which may impact essential health outcomes such as cardiovascular health.
With persistent shortages in the mental health workforce needed to address these psychological needs of HSCT caregivers adequately, remotely-delivered psychosocial interventions offer an innovative approach to overcome the unmet psychological needs of this population. Hence, the investigators developed a remotely-delivered positive psychology intervention, Positive Affect in the Transplantation of Hematopoietic Stem Cells for Caregivers (PATH-C), tailored to the unique psychological needs of HSCT caregivers. With this study, the investigators will establish the impact of PATH-C on participant-reported outcomes compared to usual care.
The study will use validated questionnaires to measure caregivers' quality of life, caregiver burden, psychological distress symptoms, positive psychological well-being (e.g., positive affect, gratitude), and self-management targets (e.g., coping, self-efficacy). The study will also use the validated ActiGraph GT3X+ accelerometer to measure minutes/day of moderate-to-vigorous physical activity, light activity, and sedentary leisure time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PATH-C | Experimental | Behavioral: PATH-CParticipants will be recruited from the Dana-Farber Cancer Institute and randomized in a 1:1 fashion, stratified by transplant type (autologous versus allogeneic), to PATH-C versus usual care. Caregivers of patients undergoing HSCT will receive the PATH-C intervention to learn to reflect on their positive emotions and consistently use and incorporate positive psychology exercises in their daily routine, as well as learn how to set goals and track their physical activity (i.e., with an activity tracker) daily while caring for a loved one undergoing HSCT. Participants will complete questionnaires (in person, over the computer or telephone, or by mail) at predetermined days per protocol. |
| Usual Care | No intervention | –Participants will be recruited from the Dana-Farber Cancer Institute and randomized in a 1:1 fashion, stratified by transplant type (autologous versus allogeneic), to PATH-C versus usual care. Participants will complete questionnaires (in person, over the computer or telephone, or by mail) at predetermined days per protocol. Participants in the usual care arm will receive their usual support from the HSCT team as caregivers of patients undergoing HSCT, including all routine supportive care resources (e.g., support from social work) offered by the HSCT team. Patients in the usual care and PATH-C groups will be permitted to use all supportive care services per standard care. The investigators will track referrals to supportive care services in both groups by reviewing the Electronic Health Record (EHR). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult caregivers (aged 18 years and older) of patients undergoing allogeneic or autologous HSCT at Dana-Farber Cancer Institute for a hematologic malignancy.
- A relative or a friend who either lives with the patient or has in-person contact with them at least twice per week and is identified as the primary caregiver for HSCT.
- Ability to speak English and able to complete questionnaires with minimal assistance of an interpreter as this is a feasibility trial of the PATH-C intervention which is currently only available in English.
Key exclusion criteria (3 listed)
- Caregivers of patients undergoing HSCT for benign hematologic conditions.
- Caregivers with acute or unstable psychiatric conditions which the treating transplant clinician believes prohibits informed consent or compliance with study procedures.
- Cognitive deficits impeding a caregiver's ability to provide informed consent or participate adequately in the study assessed via a commonly used 6-item cognitive assessment with the Brief Interview for Mental Status (BIMS) screening tool that is sensitive and specific for screening for cognitive impairment in research participants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PATH-CPATH-C, a phone-delivered positive psychology intervention for caregivers of patients undergoing HSCT, consists of the following nine sessions: 1) Enhancing gratitude and increasing awareness for physical activity; 2) Expressing gratitude and goal setting for physical activity; 3) Integrating gratitude and goals for physical activity; 4) Personal strengths and environmental scan to enhance physical activity; 5) Enhancing strengths via reflection on past successes; 6) Integrating strengths to enhance well-being and physical activity; 7) Engaging in enjoyable and meaningful activities; 8) Promoting optimism and integrating long-term activity habits; 9) Integrating meaning for sustainable physical activity goals. Each session takes about 30 minutes, and a trained interventionist will guide participants to complete the sessions. | Behavioural | PATH-C |
Primary outcome
PATH-C Intervention Feasibility
Time frame: Up to 10 weeks
PATH-C Intervention Feasibility is defined as >60% of eligible participants enrolling in the study and >60% of enrolled participants who start the intervention completing at least 6/9 intervention sessions.
6 secondary outcomes
PATH-C Intervention Acceptability
Time frame: Up to 10 weeks
Physical activity longitudinally based on ActiGraph GT3X+ accelerometer
Time frame: Up to 20 weeks (+/- 28 days)
Caregiver Quality of Life based on the CarGOQOL
Time frame: Up to 20 weeks (+/- 28 days)
Anxiety Symptoms based on the HADS-Anxiety Subscale
Time frame: Up to 20 weeks (+/- 28 days)
Depression Symptoms based on the HADS-Depression Subscale
Time frame: Up to 20 weeks (+/- 28 days)
Caregiving Burden based not the Caregiver Reaction Assessment (CRA)
Time frame: Up to 20 weeks (+/- 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: 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 the 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.
Related trials for Hematologic Malignancy
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
Active, not recruitingObservational study
Gulf Long-Term Follow-Up Study
Cardiovascular Disease, Hematologic Diseases
RecruitingPhase 1/2
The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation
Peripheral Blood Stem Cell Transplantation, Hematopoietic Stem Cell Transplantation
Not yet recruitingPhase 2
Stem Cell Transplantation for Participants With Germline RUNX1 Associated Blood Cancers
Core Binding Factor Alpha Subunits, Hematologic Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hermioni Amonoo, MD, MPP, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PATH-C in people with Hematologic Malignancy and Caregiver, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PATH-C Intervention Feasibility (time frame: Up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.