Peer Support Intervention for Blood Cancer

(STEPP Trial)

No longer recruiting at 1 trial location

Overseen By Hermioni Amonoo, MD, MPP, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Benign hematologic conditions, Outpatient HSCT, Unstable psychiatric conditions, others

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

Compensation: Varies

Number of Visits: 9

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a peer support program called STEPP (Supporting Transplant Experiences with Peer Program) benefits patients undergoing a blood stem cell transplant. The program includes five weekly sessions focusing on mental health education and supportive therapy, tailored specifically for these patients. It suits those diagnosed with blood cancer who are preparing for a bone marrow transplant. Participants will be divided into two groups: one will participate in the STEPP sessions, and the other will receive the usual care. Those undergoing their first transplant and who can communicate in English may find this suitable. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance support for future transplant patients.

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

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 doctor.

What prior data suggests that the STEPP intervention is safe for patients undergoing HSCT?

Research has shown that the STEPP program is safe for patients. In earlier studies, patients found the program helpful and relevant, appreciating the opportunity to learn from others who had experienced a stem cell transplant. No harmful side effects were reported.

The STEPP program emphasizes peer support, with sessions led by a mentor to guide participants through the transplant process. Unlike taking medication or undergoing a medical procedure, it involves talking and learning from someone who has been in a similar situation. As a result, there are few safety concerns, and participants have reported positive experiences. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care for blood cancer, which typically involves chemotherapy, radiation, or stem cell transplants, the STEPP intervention focuses on peer support to aid recovery. This approach is distinctive because it integrates virtual weekly sessions with a peer mentor, which can provide emotional and psychological support during the challenging treatment process. Researchers are excited about this approach because it could enhance patient well-being and recovery outcomes through direct, empathetic interaction, potentially addressing aspects of care that traditional medical treatments overlook.

What evidence suggests that the STEPP intervention is effective for patients undergoing HSCT?

In this trial, participants will be randomized to receive either the STEPP program or usual care. Research has shown that the STEPP program can assist patients undergoing a hematopoietic stem cell transplant (HSCT). Earlier studies found that patients benefited from the peer support in STEPP, learning from others with similar transplant experiences. This support includes five sessions focused on mental health education and therapy strategies. Patients appreciated hearing from peers with firsthand transplant experience, which helped them better manage their journey. Overall, the STEPP program appears promising in supporting patients during their HSCT process. ^{3 4 6 7 8}

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 English-speaking adults over 18 with blood cancers who are undergoing hematopoietic stem cell transplantation (HSCT). It's not suitable for those having outpatient HSCT, or individuals with acute psychiatric or cognitive conditions that prevent informed consent or study compliance.

Inclusion Criteria

Ability to comprehend, read, and respond to questions in English as STEPP is only available in English

I am over 18 and have a blood cancer treated with a stem cell transplant.

Exclusion Criteria

Patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures

I am receiving a stem cell transplant as an outpatient.

I am having a stem cell transplant for a non-cancerous blood condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person or remote)

Treatment

Participants receive the STEPP intervention or usual care, including weekly virtual sessions for five weeks

5 weeks

5 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments on Day +30 and Day +60

4 weeks

2 visits (self-reported assessments)

Optional Exit Interview

Participants may opt for an exit interview with study staff

1 week

1 visit (in-person or remote)

What Are the Treatments Tested in This Trial?

Interventions

• STEPP Intervention

Trial Overview The trial is testing STEPP, a peer support intervention with five modules designed to educate and provide psychotherapy support tailored to the needs of patients receiving HSCT. The goal is to see if this approach is practical and helpful.

How Is the Trial Designed?

Group I: STEPP Experimental Treatment 1 Intervention

Participants will be randomized in 1:1 fashion, stratified by transplant type (autologous vs. allogeneic), and will complete study procedures as follows: * Baseline self-reported assessment (in-person or remotely). * Virtual, STEPP intervention sessions 1x weekly for five weeks with peer mentor. * HSCT and hospitalization per standard of care. * Day +30 (+/- 10 days) and Day +60 (+/- 10 days) self-reported assessments. * Optional exit interview with study staff (40 participants).

Group II: Usual Care Active Control 1 Intervention

Participants will be randomized in 1:1 fashion, stratified by transplant type (autologous vs. allogeneic), and will complete study procedures as follows: * Baseline self-reported assessment. * HSCT and hospitalization per standard of care. * Day +30 (+/- 10 days) and Day +60 (+/- 10 days) self-reported assessments.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Published Research Related to This Trial

The iCAN-DO internet-based stepped care program significantly reduced symptoms of depression in cancer patients compared to standard care, with a notable decrease in depression levels observed at the 10-month assessment.

While iCAN-DO showed effectiveness in alleviating depression, it did not have a significant impact on anxiety, posttraumatic stress, or health-related quality of life, indicating a need for further research to enhance its overall efficacy in oncology care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cocreated internet-based stepped care for individuals with cancer and concurrent symptoms of anxiety and depression: Results from the U-CARE AdultCan randomized controlled trial. Hauffman, A., Alfonsson, S., Bill-Axelson, A., et al.[2021]

A 6-month peer-counseling intervention for newly diagnosed women with breast cancer (Sojourners) showed significant improvements in trauma symptoms, emotional well-being, and cancer self-efficacy, indicating that peer support can positively impact their quality of life during treatment.

While peer counselors (Navigators) did not experience negative effects from their role, they reported increased dissatisfaction with medical interactions and emotional suppression, highlighting the need for careful training and supervision to ensure the success of peer navigator programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of peer counseling on quality of life following diagnosis of breast cancer: an observational study. Giese-Davis, J., Bliss-Isberg, C., Carson, K., et al.[2022]

A systematic review of 29 studies found that cancer peer support interventions significantly enhance psychological empowerment in patients, particularly in areas like active coping, self-efficacy, and knowledge.

The evidence suggests that while the impact of peer support on empowerment is moderate, it is associated with additional patient-reported benefits, highlighting the importance of integrating peer support into cancer care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowerment in cancer patients: Does peer support make a difference? A systematic review. Ziegler, E., Hill, J., Lieske, B., et al.[2022]

A study involving 34 diverse adult hematopoietic stem cell transplant survivors revealed a strong desire for written peer support to supplement the information provided by healthcare providers, highlighting a gap in their informational needs.

Participants expressed enthusiasm for online written peer support, emphasizing the importance of tailoring the content to individual transplant experiences and ensuring it is trustworthy and accompanied by psychoeducational resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing use of written peer support as a supportive resource in cancer: Focus group insights. Rini, C., Waltz, M., Bovbjerg, K., et al.[2022]

A systematic review of eight studies involving 574 patients with hematologic malignancies or those who underwent hematopoietic stem cell transplantation (HSCT) found that peer support may lead to improved physical symptoms and overall health outcomes.

Despite some positive findings, the literature on peer support in this population is limited, indicating a need for more randomized controlled trials to better understand its effectiveness and develop empirically based interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer support in patients with hematologic malignancies: a systematic review. Amonoo, HL., Harnedy, LE., Staton, SC., et al.[2022]

Former patients treated for acute leukemia are motivated to become peer support providers because it helps them find meaning in their own experiences and facilitates their recovery by boosting self-confidence.

The desire to instill hope in newly diagnosed patients is a key motivator, highlighting the importance of readiness and ongoing support in peer-to-peer programs for effective patient assistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The motivation to volunteer as a peer support provider to newly diagnosed patients with acute leukemia - A qualitative interview study. Myrhøj, CB., Nørskov, KH., Jarden, M., et al.[2020]

A systematic review of 18 studies, including 16 randomized controlled trials, evaluated the effects of peer-led supportive interventions for cancer patients, focusing on various outcomes like emotional health and quality of life.

The results indicate a need for more rigorous, theory-based evaluations to confirm the effectiveness of these peer-led interventions in cancer care, suggesting that while promising, further research is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Peer-Led Interventions for Patients With Cancer: A Meta-Analysis Lee, MK., Suh, SR.[2019]

A study involving 25 hematopoietic stem cell transplant (HSCT) recipients revealed that while 70% had no formal experience with peer support, 83% recognized its potential benefits, such as managing expectations and uncertainty during recovery.

Most participants (60%) expressed a preference for initiating a peer support intervention before their HSCT hospitalization, indicating a strong desire for support during the pre-transplant phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer support in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT): a qualitative study. Amonoo, HL., Harnedy, LE., Deary, EC., et al.[2022]

The one-on-one peer support intervention for family caregivers of newly diagnosed hematological cancer patients was found to be feasible and safe, with no adverse events reported during the study involving 26 caregivers and 17 caregiver ambassadors.

Caregivers expressed high satisfaction with the support received, and most showed improvement in psychosocial outcomes over the 12-week intervention, suggesting that this model could effectively support caregivers in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family caregiver ambassador support for caregivers of patients with newly diagnosed hematological cancer: a feasibility study. Husted Nielsen, I., Piil, K., Tolver, A., et al.[2022]

The review analyzed 43 studies on peer support models for cancer patients, identifying five types: one-on-one face-to-face, one-on-one telephone, group face-to-face, group telephone, and group Internet, with a focus on their effectiveness in improving psychosocial adjustment.

While participants reported high satisfaction with peer-support programs, the evidence for actual psychosocial benefits was mixed, suggesting that more research is needed, especially for models other than one-on-one face-to-face and group Internet support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of peer-support programs for people with cancer. Hoey, LM., Ieropoli, SC., White, VM., et al.[2022]

Citations

1. astctjournal.org astctjournal.org/article/S2666-6367(24)00689-4/fulltext

A Peer Support Intervention in Patients With Hematologic ... Patients reported STEPP was useful and relevant for gaining perspectives from HSCT survivors with lived experience of the transplant. •.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39332809/

A Peer Support Intervention in Patients With Hematologic ... This single-arm, proof-of-concept trial aimed to refine the Supporting Transplant Experiences with Peer Program (STEPP), a structured, five-session, manualized ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2666636725011133

A Structured Peer Support Intervention for Patients with ... This qualitative study aimed to explore the experiences of peer support interventionists (participants) delivering a structured, five-session, phone-delivered ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155171442400329X

A peer support intervention in patients with hematologic ... This single-center pilot randomized clinical trial (RCT) will compare the STEPP intervention to usual transplant care among 90 patients hospitalized for HSCT.

5. astctjournal.org astctjournal.org/article/S2666-6367(25)01113-3/fulltext

A Structured Peer Support Intervention for Patients With ... This qualitative study aimed to explore the experiences of peer support interventionists (participants) delivering a structured, 5-session, phone-delivered ...

6. nature.com nature.com/articles/s41409-022-01711-9

Peer support in patients with hematologic malignancies ... Our study shows that HSCT recipients clearly acknowledge the potential benefits of a peer support intervention, and they prefer that it start prior to ...

7. researchgate.net researchgate.net/publication/385960264_A_peer_support_intervention_in_patients_with_hematologic_malignancies_undergoing_hematopoietic_stem_cell_transplantation_HSCT_The_STEPP_randomized_pilot_trial_design_and_methods_outline

A peer support intervention in patients with hematologic ... A peer support intervention in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT): The STEPP ...

8. withpower.com withpower.com/trial/phase-neoplasms-1-2024-72f5a

Peer Support Intervention for Blood Cancer (STEPP Trial) The main purpose of this study is to determine if a novel peer support intervention (STEPP) is feasible among patients undergoing hematopoietic stem cell ...