Positive Psychology for Bone Marrow Transplant Survivors

(PATH-4 Trial)

Recruiting at 2 trial locations

Overseen By Isabella Larizza, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Benign hematologic conditions, Outpatient HSCT, Severe psychiatric or cognitive conditions

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

400 Participants Needed

Trial Summary

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment PATH, MATCH, PATH 2.0 for bone marrow transplant survivors?

Research shows that positive psychology interventions, like the PATH treatment, are feasible and acceptable for bone marrow transplant survivors, with small-to-medium improvements in patient-reported outcomes. Positive psychological constructs, such as optimism, have been linked to better health outcomes in similar medical populations. ^{1 2 3 4 5}

Is the Positive Psychology intervention safe for bone marrow transplant survivors?

The Positive Psychology intervention, tested as PATH, was found to be feasible and acceptable in bone marrow transplant survivors, with no safety concerns reported in the study. ^{1 2 3 6 7}

How is the PATH treatment different from other treatments for bone marrow transplant survivors?

The PATH treatment is unique because it uses positive psychology interventions (PPIs) delivered over the phone to improve psychological well-being in bone marrow transplant survivors, focusing on exercises like writing gratitude letters to enhance positive emotions, which is not a standard approach in this context. ^{1 2 5 6 8}

What is the purpose of 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.

Research Team

Hermioni Amonoo, MD, MPP

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for adults over 18 who have had a bone marrow transplant (allogeneic HSCT) and are about 100 days post-transplant. They must be able to communicate in English or Spanish and have access to a phone. It's not for those with benign hematologic conditions, outpatient HSCT, or severe psychiatric issues like dementia.

Inclusion Criteria

I am an adult who had a stem cell transplant from a donor and it's been almost 100 days since.

Access to a basic telephone

I can speak, read, and understand English or Spanish for study needs.

Exclusion Criteria

I have undergone a stem cell transplant as an outpatient.

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

I had a stem cell transplant from a donor for a non-cancer blood condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the PATH intervention focused on gratitude, strengths, and meaning, with exercises on goal-setting and tracking daily physical activity

10 weeks

Questionnaires completed in person, over the computer or telephone, or by mail at predetermined days

Follow-up

Participants are monitored for psychological distress and quality of life improvements using validated assessment tools

Up to 40 weeks

Treatment Details

Interventions

• PATH

Trial Overview The study is testing the PATH program, which uses positive psychology techniques to see if it can improve anxiety, depression symptoms, and life quality after bone marrow transplant compared to usual care. Participants will be randomly assigned to either receive PATH or continue with their standard follow-up.

Participant Groups

Group I: Positive Affect in the Transplantation of Hematopoietic Stem Cells (PATH) Experimental Treatment 1 Intervention

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.

Group II: Usual Care Active Control 1 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.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

H. Lee Moffitt Cancer Center and Research Institute

Collaborator

Trials

576

Recruited

145,000+

Findings from Research

A novel eight-session, telephone-delivered positive psychology intervention (PPI) was found to be feasible and acceptable for allogeneic hematopoietic stem cell transplantation (HSCT) recipients, with 55.6% of eligible patients enrolling and 60% completing at least 5 out of 8 sessions.

The intervention showed small-to-medium effect-size improvements in positive psychological well-being, indicating potential benefits, but larger randomized studies are needed to confirm its efficacy in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A positive psychology intervention to promote health outcomes in hematopoietic stem cell transplantation: the PATH proof-of-concept trial. Amonoo, HL., El-Jawahri, A., Celano, CM., et al.[2023]

In a study involving 25 hematopoietic stem cell transplantation (HSCT) patients, key positive psychological constructs such as gratitude, determination, and optimism were identified as significant factors influencing recovery during the first 100 days post-transplant.

Family support and engaging in meaningful activities were found to be the main sources of these positive experiences, which in turn were linked to improved health behaviors and overall psychological well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive psychological experiences in allogeneic hematopoietic stem cell transplantation. Amonoo, HL., Brown, LA., Scheu, CF., et al.[2020]

A systematic review of 18 studies involving 4201 patients with hematologic malignancies receiving hematopoietic stem cell transplantation (HSCT) found that positive psychological constructs, particularly optimism, are significantly associated with improved health-related quality of life (HRQoL) and other health outcomes.

All quantitative studies in the review reported significant associations (P < .05) between positive psychological constructs and health outcomes, suggesting that fostering optimism and positive affect could be beneficial for patients undergoing HSCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive Psychological Constructs and Health Outcomes in Hematopoietic Stem Cell Transplantation Patients: A Systematic Review. Amonoo, HL., Barclay, ME., El-Jawahri, A., et al.[2019]

In a study of 135 long-term survivors of bone marrow transplantation, participants reported more positive changes in relationships and psychological aspects, but more negative changes in physical health, highlighting the complex nature of recovery.

Negative personal changes were found to have a stronger impact on current and future life satisfaction and mood than positive changes, suggesting that addressing negative experiences may be crucial for psychological adjustment post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personal changes, dispositional optimism, and psychological adjustment to bone marrow transplantation. Curbow, B., Somerfield, MR., Baker, F., et al.[2019]

The WISE trial is a randomized controlled study designed to evaluate the efficacy of a brief psychological intervention called expressive helping for adult hematological cancer patients undergoing hematopoietic stem cell transplant, aiming to reduce physical and psychological symptoms during and after the transplant process.

Expressive helping combines emotionally expressive writing and peer support, and is expected to improve health-related quality of life and reduce distress and fatigue, potentially preventing long-term survivorship issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of expressive helping in adult hematologic cancer patients undergoing stem cell transplant: protocol for the Writing for Insight, Strength, and Ease (WISE) study's two-arm randomized controlled trial. Whitmore, L., Schulte, T., Bovbjerg, K., et al.[2021]

In a study of 156 patients undergoing hematopoietic stem cell transplantation (HSCT), many reported high levels of positive psychological well-being (PPWB), including optimism and gratitude, but a significant minority (29%) did not feel optimistic about their future.

The findings suggest that while most HSCT patients experience positive emotions, there is a need for further research to explore interventions that could enhance PPWB, as it is linked to better clinical outcomes and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive Psychological Well-Being in Hematopoietic Stem Cell Transplantation Survivors. Amonoo, HL., Lam, JA., Daskalakis, E., et al.[2023]

Recent studies suggest that negative emotional states, such as depression, negatively impact long-term survival after hematopoietic stem cell transplantation (HSCT), while optimism may positively influence short-term outcomes.

The review emphasizes the need for pre-transplant psychological evaluations to identify adverse behavioral risk factors, advocating for collaborative studies and clinical trials to explore psychological interventions that could improve transplant outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do negative or positive emotions differentially impact mortality after adult stem cell transplant? Hoodin, F., Uberti, JP., Lynch, TJ., et al.[2006]

A review of 15 studies on psychosocial factors affecting survival after bone marrow transplantation found that psychological variables like depressed mood and social support do not significantly impact survival rates in adults and children.

However, factors such as lower anxious preoccupation, higher fighting spirit, and better quality of life ratings before and shortly after the transplant may be associated with longer survival, indicating that certain positive psychological traits could play a role.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of psychosocial factors affecting survival after bone marrow transplantation. Hoodin, F., Weber, S.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

A positive psychology intervention to promote health outcomes in hematopoietic stem cell transplantation: the PATH proof-of-concept trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Positive psychological experiences in allogeneic hematopoietic stem cell transplantation. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Positive Psychological Constructs and Health Outcomes in Hematopoietic Stem Cell Transplantation Patients: A Systematic Review. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Personal changes, dispositional optimism, and psychological adjustment to bone marrow transplantation. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy of expressive helping in adult hematologic cancer patients undergoing stem cell transplant: protocol for the Writing for Insight, Strength, and Ease (WISE) study's two-arm randomized controlled trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Positive Psychological Well-Being in Hematopoietic Stem Cell Transplantation Survivors. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Do negative or positive emotions differentially impact mortality after adult stem cell transplant? [2006]

8. England pubmed.ncbi.nlm.nih.gov

A systematic review of psychosocial factors affecting survival after bone marrow transplantation. [2022]