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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a positive psychology program called PATH can reduce anxiety and depression and improve the quality of life for bone marrow transplant survivors. PATH includes activities such as expressing gratitude, recognizing personal strengths, and setting goals. Participants will either join the PATH program or continue with their usual care for comparison. This trial may suit individuals who have undergone a bone marrow transplant, are nearing 100 days post-transplant, and can communicate in English or Spanish. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance emotional well-being for future transplant survivors.

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 prior data suggests that the PATH intervention is safe for bone marrow transplant survivors?

Research has shown that positive psychology activities, like those in PATH, are generally safe. PATH includes activities such as gratitude exercises and setting personal goals. Studies have not shown any serious negative effects from these activities, which are easy to handle. Participants often report feeling more optimistic or less stressed. This trial does not test a drug or medical procedure, so there is no risk of physical side effects. Instead, it uses mental exercises to help improve mood and quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PATH intervention for bone marrow transplant survivors because it uniquely focuses on enhancing positive emotions like gratitude and meaning. Unlike usual care, which centers on routine support services, PATH emphasizes psychological well-being through tailored exercises, such as goal-setting and tracking daily physical activity. This innovative approach aims to boost mental health and overall recovery, offering a fresh perspective compared to standard supportive care methods.

What evidence suggests that the PATH intervention could be effective for improving anxiety, depression, and quality of life in bone marrow transplant survivors?

Research has shown that the PATH program, which participants in this trial may receive, can benefit individuals who have undergone a bone marrow transplant. Previous studies have linked PATH to better mental health, improved quality of life, enhanced physical abilities, and reduced fatigue. The program includes activities such as practicing gratitude, recognizing personal strengths, and finding meaning in life, which can boost mood and overall mental health. By increasing positive feelings, PATH might also help extend life after transplants. These findings suggest that PATH could be a valuable tool for improving life post-transplant. ^{6 7 8 9 10}

Who Is on the Research Team?

Hermioni Amonoo, MD, MPP

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423001957

Feasibility of a positive psychology intervention (PATH) in ... A positive psychology intervention to promote health outcomes in hematopoietic stem cell transplantation: the PATH proof-of-concept trial. Bone Marrow ...

2. jnccn.org jnccn.org/abstract/journals/jnccn/22/2D/article-e237117.xml

A Pilot Randomized Clinical Trial in PATH is feasible, with promising signals for improving psychological well-being, QoL, physical function, and fatigue in HSCT survivors.

3. astctjournal.org astctjournal.org/article/S1083-8791(18)30597-4/fulltext

Positive Psychological Constructs and Health Outcomes in ... Pre-transplant emotional support is associated with longer survival after allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant. 2016 ...

4. researchgate.net researchgate.net/publication/381331820_A_Positive_Psychology_Intervention_in_Allogeneic_Hematopoietic_Stem_Cell_Transplantation_Survivors_PATH_A_Pilot_Randomized_Clinical_Trial

A Positive Psychology Intervention in Allogeneic ... Conclusions: PATH is feasible, with promising signals for improving psychological well-being, QoL, physical function, and fatigue in HSCT survivors. Future ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10529897/

Positive Psychological Well-Being in Hematopoietic Stem ... A positive psychology intervention to promote health outcomes in hematopoietic stem cell transplantation: the PATH proof-of-concept trial. Bone Marrow ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01166009

Study Details | NCT01166009 | CIBMTR Research Database A primary outcome is to have a comprehensive source of stem cell transplant data that can be used to assess topics such as: Recipient Recover time; How recovery ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.24.00333

Randomized Controlled Trial of a Virtually Delivered ... This multicenter trial aimed to assess the short- and long-term effects of an exercise and mindfulness intervention delivered by telehealth.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7113189/

Benchmarking of survival outcomes following ... A total of 352 centres, providing data of 65,347 patients have contributed to this benchmarking project for autologous transplants. Figures 4 ...

9. ashpublications.org ashpublications.org/bloodadvances/article/9/5/955/525812/Hematopoietic-cell-transplant-compared-with

Hematopoietic cell transplant compared with standard care in ... The 2-year probabilities of survival were 89% and 93%, in the donor vs no donor arms. Vaso-occlusive pain (VOC) was less frequent in the donor ...

10. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT02401009

Study Details | CIBMTR Research Database A primary outcome is to have a comprehensive source of stem cell transplant data that can be used to assess topics such as: Recipient Recover time; How recovery ...