PATH-C Intervention for Caregivers of Blood Cancer Survivors

(PATH-C Trial)

Overseen by Hermioni Amonoo, MD, MPP

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Brigham and Women's Hospital

Disqualifiers: Benign hematologic conditions, Unstable psychiatric, Cognitive deficits

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the PATH-C treatment for caregivers of blood cancer survivors?

Research shows that positive psychology interventions, like PATH-C, which involve activities such as writing gratitude letters, have been effective in improving psychological well-being in medical populations, including those recovering from stem cell transplants. Additionally, similar interventions have been shown to enhance coping skills and quality of life for caregivers, suggesting potential benefits for caregivers of blood cancer survivors. ^{1 2 3 4 5}

Is the PATH-C intervention safe for caregivers of blood cancer survivors?

The PATH intervention, a positive psychology program, was found to be feasible and acceptable in a study with hematopoietic stem cell transplant recipients, suggesting it is generally safe for use in humans. ^{1 4 6 7 8}

How is the PATH-C treatment for caregivers of blood cancer survivors different from other treatments?

The PATH-C treatment is unique because it focuses on providing support to caregivers of blood cancer survivors, addressing their psychological distress and quality of life through approach-oriented coping strategies, which are linked to better mental health outcomes. Unlike standard medical treatments for patients, this intervention specifically targets the emotional and mental well-being of caregivers, which is often overlooked. ^{5 6 9 10 11}

Research Team

Hermioni Amonoo, MD, MPP

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for adult caregivers of patients undergoing stem cell transplants at Dana-Farber Cancer Institute for blood cancers. Caregivers must be primary support, in regular contact with the patient, and able to speak English. Those caring for non-cancer conditions or with acute psychiatric issues or cognitive deficits that affect consent or participation are excluded.

Inclusion Criteria

I have a primary caregiver who sees me at least twice a week.

I can speak English and fill out forms with little help.

I am an adult caregiver for a patient receiving a stem cell transplant at Dana-Farber.

Exclusion Criteria

Caregivers with acute or unstable psychiatric conditions which the treating transplant clinician believes prohibits informed consent or compliance with study procedures

Caregivers of patients undergoing HSCT for benign hematologic conditions

My mental ability to understand and decide on my care is clear.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the PATH-C intervention to learn positive psychology exercises and track physical activity

10 weeks

Weekly sessions (remote)

Follow-up

Participants are monitored for psychological well-being, quality of life, and physical activity

10 weeks

Treatment Details

Interventions

• PATH-C (Behavioral Intervention)

Trial Overview The study tests a positive psychology intervention called PATH-C aimed at improving well-being, quality of life, and physical activity among caregivers of hematopoietic stem cell transplant recipients. Participants will be randomly assigned to receive this intervention as part of the trial's evaluation process.

Participant Groups

Group I: PATH-C Experimental Treatment 1 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. 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.

Group II: Usual Care Active Control 1 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 Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Dr. William Curry

Brigham and Women's Hospital

Chief Medical Officer

MD from Columbia University College of Physicians and Surgeons

Dr. Scott Schissel

Brigham and Women's Hospital

Chief Executive Officer since 2021

MD from Columbia University College of Physicians and Surgeons

Robert Wood Johnson Foundation

Collaborator

Trials

161

Recruited

697,000+

Dr. Kemi Alli

Robert Wood Johnson Foundation

Chief Medical Officer since 2015

MD from Brown University

Dr. Richard E. Besser

Robert Wood Johnson Foundation

Chief Executive Officer since 2017

MD from the University of Pennsylvania

American Society of Hematology

Collaborator

Trials

14

Recruited

20,800+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management

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]

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]

The BMT-CARE intervention, a 6-session program for caregivers of hematopoietic stem cell transplantation recipients, significantly improved their quality of life and mood, with 100 caregivers participating in the study.

Improvements in coping skills and self-efficacy were found to mediate these positive effects, accounting for a substantial portion of the intervention's impact on quality of life and reductions in depression and anxiety symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced coping and self-efficacy in caregivers of stem cell transplant recipients: Identifying mechanisms of a multimodal psychosocial intervention. Jacobs, JM., Nelson, AM., Traeger, L., et al.[2023]

The therapeutic music video (TMV) intervention significantly improved courageous coping among adolescents and young adults undergoing hematopoietic stem cell transplant, with a notable effect size of 0.505 after the intervention.

At 100 days post-transplant, the TMV group showed significant improvements in social integration and family environment, suggesting that TMV can enhance supportive factors during high-risk cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of therapeutic music video intervention for resilience outcomes in adolescents/young adults undergoing hematopoietic stem cell transplant: a report from the Children's Oncology Group. Robb, SL., Burns, DS., Stegenga, KA., et al.[2022]

In a study of 170 caregivers of patients undergoing hematopoietic stem cell transplantation, those who used approach-oriented coping strategies reported significantly lower levels of anxiety and depression, as well as better quality of life.

Conversely, caregivers who relied on avoidant coping strategies experienced higher anxiety and depression symptoms, along with a worse quality of life, highlighting the importance of promoting adaptive coping resources for these caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping in caregivers of patients with hematologic malignancies undergoing hematopoietic stem cell transplantation. Amonoo, HL., Johnson, PC., Nelson, AM., et al.[2023]

A qualitative environmental scan of Hematopoietic Stem Cell Transplant (HCT) programs in Canada revealed significant variation in how psychosocial needs of patients and caregivers are assessed and supported before transplantation.

Most programs rely heavily on social workers for psychosocial assessments, with limited use of psychologists and psychiatrists, highlighting a need for standardized assessment tools and further research to identify effective strategies for supporting psychosocial wellbeing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing and Preparing Patients for Hematopoietic Stem Cell Transplant in Canada: An Environmental Scan of Psychosocial Care. Beattie, S., Qureshi, M., Pink, J., et al.[2023]

A study involving 489 hematopoietic cell transplantation (HCT) survivors developed risk prediction models for assessing long-term physical and psychological functioning, identifying key predictors such as age, body mass index (BMI), and chronic graft-versus-host disease.

The models demonstrated moderate diagnostic accuracy, with the physical functioning model achieving an area under the curve (AUC) of 0.74 and the psychological functioning model an AUC of 0.69, suggesting that while useful, further refinement is needed for clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Risk Prediction Model for Long-Term Physical and Psychological Functioning after Hematopoietic Cell Transplantation. Braamse, AM., Yi, JC., Visser, OJ., et al.[2018]

In a study of 70 adult patients undergoing myeloablative hematopoietic cell transplantation (HCT), higher levels of pre-transplant anxiety and depression were linked to slower recovery of white blood cell (WBC) counts during the first three weeks post-transplant.

These findings suggest that psychological distress can negatively impact immune recovery, highlighting the importance of addressing anxiety and depression in HCT patients to improve their recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of pre-transplant distress on immune reconstitution among adult autologous hematopoietic cell transplantation patients. McGregor, BA., Syrjala, KL., Dolan, ED., et al.[2021]

A pilot study involving 21 caregivers of cancer patients undergoing stem cell transplants showed that a 6-week mindfulness-based intervention (FOCUS) was highly feasible and acceptable, with 71% attending at least four sessions and all participants reporting skill usage at follow-up.

Participants experienced significant improvements in mindfulness, post-traumatic growth, and general mental health, along with reductions in negative emotions, indicating that FOCUS effectively supports caregivers' mental well-being during a stressful period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mindfulness-based intervention for caregivers of allogeneic hematopoietic stem cell transplant patients: Pilot results. Vinci, C., Pidala, J., Lau, P., et al.[2020]

Caregivers of lymphoma survivors who have a higher sense of personal control report better quality of life, highlighting the importance of psychological resources in caregiver adaptation.

Survivor functional health status impacts caregiver quality of life, but this effect is mitigated when survivors feel a strong sense of personal control, suggesting that emotional support and empowerment can improve outcomes for caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term implications of autologous HCT for caregiver quality of life: how does the survivor's health matter? Stepanikova, I., Powroznik, K., Cook, K., et al.[2019]

The study successfully adapted an in-person stress management intervention for caregivers of cancer patients into a mobile-friendly format called Pep-Pal, which consists of 9 sessions focused on various stress management topics.

Feedback from caregivers and palliative care experts indicated that Pep-Pal was acceptable and user-friendly, suggesting it could effectively reach and support caregivers in managing their stress and emotional well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Web-Based Intervention for Addressing Distress in Caregivers of Patients Receiving Stem Cell Transplants: Formative Evaluation With Qualitative Interviews and Focus Groups Pensak, NA., Joshi, T., Simoneau, T., et al.[2020]

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

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]

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

Enhanced coping and self-efficacy in caregivers of stem cell transplant recipients: Identifying mechanisms of a multimodal psychosocial intervention. [2023]

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

Randomized clinical trial of therapeutic music video intervention for resilience outcomes in adolescents/young adults undergoing hematopoietic stem cell transplant: a report from the Children's Oncology Group. [2022]

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

Coping in caregivers of patients with hematologic malignancies undergoing hematopoietic stem cell transplantation. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Assessing and Preparing Patients for Hematopoietic Stem Cell Transplant in Canada: An Environmental Scan of Psychosocial Care. [2023]

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

Developing a Risk Prediction Model for Long-Term Physical and Psychological Functioning after Hematopoietic Cell Transplantation. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of pre-transplant distress on immune reconstitution among adult autologous hematopoietic cell transplantation patients. [2021]

9. England pubmed.ncbi.nlm.nih.gov

A mindfulness-based intervention for caregivers of allogeneic hematopoietic stem cell transplant patients: Pilot results. [2020]

10. Germany pubmed.ncbi.nlm.nih.gov

Long-term implications of autologous HCT for caregiver quality of life: how does the survivor's health matter? [2019]

11. Canada pubmed.ncbi.nlm.nih.gov

Development of a Web-Based Intervention for Addressing Distress in Caregivers of Patients Receiving Stem Cell Transplants: Formative Evaluation With Qualitative Interviews and Focus Groups [2020]