Peer Support Intervention for Blood Cancer

(STEPP Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Hermioni Amonoo, MD, MPP

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

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

No Placebo Group

Trial Summary

What is the purpose of this 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 transplantation (HSCT). The name of the intervention used in this research study is STEPP, a peer support intervention comprised of five learning modules on psychoeducation and supportive psychotherapy strategies, tailored to the unique needs of patients undergoing HSCT.

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 data supports the effectiveness of the STEPP Intervention treatment for blood cancer?

Research shows that peer support, where patients help each other based on shared experiences, can improve mood and emotional well-being in cancer patients. Although specific data for blood cancer is limited, similar peer support programs have shown benefits in managing expectations and improving quality of life in other cancer types. ^{1 2 3 4 5}

Is peer support intervention safe for people with blood cancer?

There is limited information on the safety of peer support interventions specifically for blood cancer patients, but studies suggest that peer support is generally seen as beneficial and does not report any safety concerns. Participants in studies have expressed positive views on the potential benefits of peer support, such as managing expectations and uncertainty during treatment. ^{1 2 6 7 8}

How is the peer support intervention treatment for blood cancer different from other treatments?

The peer support intervention for blood cancer is unique because it focuses on providing emotional, social, and practical help from individuals who have experienced similar health challenges, rather than using medication or medical procedures. This approach aims to improve patients' mood and help them manage expectations and uncertainties, especially before undergoing treatments like hematopoietic stem cell transplantation. ^{1 2 6 9 10}

Research Team

Hermioni Amonoo, MD, MPP

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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

I am receiving a stem cell transplant as an outpatient.

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

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

Trial Timeline

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)

Treatment Details

Interventions

• STEPP Intervention (Behavioral 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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Dana-Farber Cancer Institute Boston, MA

Brigham and Women's Hospital Boston, MA

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1128

Patients Recruited

382,000+

Brigham and Women's Hospital

Lead Sponsor

Trials

1694

Patients Recruited

14,790,000+

Findings from Research

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

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]

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]

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]

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]

References

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

Peer support in patients with hematologic malignancies: a systematic review. [2022]

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

Peer support in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT): a qualitative study. [2022]

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

Effects of Peer-Led Interventions for Patients With Cancer: A Meta-Analysis [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Family caregiver ambassador support for caregivers of patients with newly diagnosed hematological cancer: a feasibility study. [2022]

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

The effect of peer counseling on quality of life following diagnosis of breast cancer: an observational study. [2022]

6. Scotland 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. [2020]

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

Optimizing use of written peer support as a supportive resource in cancer: Focus group insights. [2022]

8. England 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. [2021]

9. Ireland pubmed.ncbi.nlm.nih.gov

Systematic review of peer-support programs for people with cancer. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Empowerment in cancer patients: Does peer support make a difference? A systematic review. [2022]