PATH-C Intervention for Caregivers of Blood Cancer Survivors

(PATH-C Trial)

Overseen By Hermioni Amonoo, MD, MPP, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Benign hematologic conditions, Unstable psychiatric, Cognitive deficits

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called PATH-C to determine if it can improve the mental well-being, quality of life, and activity levels of caregivers of blood cancer patients. Caregivers will learn to focus on positive emotions and set activity goals while caring for loved ones receiving stem cell transplants. The trial compares this approach to the usual support provided by the transplant team. Ideal participants are English-speaking caregivers who regularly visit or live with a blood cancer patient undergoing a stem cell transplant at Dana-Farber Cancer Institute. As an unphased trial, this study offers caregivers a unique opportunity to enhance their well-being and support their loved ones in a new way.

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 prior data suggests that the PATH-C intervention is safe for caregivers?

Research shows that the PATH-C program, a positive psychology approach for caregivers, is generally easy to manage. Previous studies have examined the practicality and acceptability of this program for those caring for individuals undergoing hematopoietic stem cell transplantation (HSCT). These studies did not identify any serious side effects or problems.

The PATH-C program includes activities to boost positive feelings and encourages setting goals and tracking physical activity. This non-invasive program does not involve medical procedures or medications that could cause physical harm. Instead, it focuses on mental and emotional well-being, which typically carries a low risk of negative effects.

In summary, existing research supports the safety of the PATH-C program for caregivers, as no major safety issues have been identified so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PATH-C intervention because it uniquely focuses on enhancing the well-being of caregivers for blood cancer survivors. Unlike standard care, which typically includes routine support from healthcare teams, PATH-C emphasizes positive psychology and physical activity. Caregivers learn to reflect on positive emotions and incorporate exercises into their daily lives, aiming to improve mental health and resilience. This holistic approach could offer significant benefits by promoting caregivers' emotional and physical health, ultimately improving the care they provide to their loved ones.

What evidence suggests that the PATH-C intervention is effective for improving well-being in caregivers of blood cancer survivors?

Research has shown that positive psychology activities, such as PATH-C, which participants in this trial may receive, can improve caregivers' well-being. In one study, 91% of participants completed all sessions and found the activities easy and helpful. Past participants reported improvements in mental health and quality of life. Additionally, a nine-week phone-based positive psychology program proved effective for caregivers of transplant patients. These findings suggest that PATH-C may help caregivers manage stress and enhance their mood while supporting their loved ones through treatment. ^{1 2 4 6 7}

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 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 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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• PATH-C

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.

How Is the Trial Designed?

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+

Robert Wood Johnson Foundation

Collaborator

Trials

161

Recruited

697,000+

American Society of Hematology

Collaborator

Trials

14

Recruited

20,800+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38266964/

A Positive Psychology Intervention for Caregivers of ... - PubMed This is the first study to show a 9-wk, phone-delivered positive psychology intervention is feasible in caregivers of allogeneic HSCT recipients.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06153797

A Positive Psychology Based Intervention (PATH-C) for ... The goal of this randomized clinical trial is to evaluate whether a positive psychology intervention (PATH-C) can improve psychological well-being, quality of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11009093/

A Positive Psychology Intervention for Caregivers ... The goal of this single-arm open-pilot trial was to determine the feasibility and acceptability of the Positive Affect in the Transplantation of Hematopoietic ...

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

Feasibility of a positive psychology intervention (PATH) in ... The goal of this single-arm open-pilot trial was to determine the feasibility and acceptability of the Positive Affect in the Transplantation of Hematopoietic ...

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

A Pilot Randomized Clinical Trial in Of those randomized to PATH, 91% completed all sessions and reported positive psychology exercises as easy to complete and subjectively useful.

6. dana-farber.org dana-farber.org/clinical-trials/21-596

Proof-of-Concept Trial of a Positive Psychology ... Proof-of-Concept Trial of a Positive Psychology Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (PATH-C) · Trial ...

7. sciencedirect.com sciencedirect.com/science/article/am/pii/S2666636724001581

A Positive Psychology Intervention for Caregivers of ... A Positive Psychology Intervention for Caregivers of Hematopoietic Stem Cell Transplantation. Survivors (PATH-C): Initial Testing and Single-Arm Pilot Trial.