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Completed

NCT Number: NCT06010017

Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation

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.

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Key information

Conditions

Hematopoietic Neoplasms Hematologic Diseases Hematologic Neoplasms Hematopoietic Malignancy Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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About this study

The goal of this project is to refine a peer support intervention (STEPP) for patients undergoing hematopoietic stem cell transplantation (HSCT) and to conduct a randomized clinical trial to test its feasibility and preliminary efficacy for improving quality of life (QOL) and reducing psychological distress.

Participants will be randomized into one of two study groups: Peer Support Intervention (STEPP) vs. Usual Care. Randomization means a participant is placed into a group by chance. Participants will have an equal chance of being placed in either group.

Study procedures include screening for eligibility and questionnaires.

Participation in this study is expected to last about 10 weeks.

It is expected that about 80 people will participate in this randomized clinical trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (age > 18 years) with a hematologic malignancy undergoing autologous or allogeneic HSCT.
  • Ability to comprehend, read, and respond to questions in English as STEPP is only available in English.

Exclusion criteria

  • Patients undergoing HSCT for benign hematologic conditions.
  • Patients undergoing outpatient HSCT.
  • Patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures.
  • Patients undergoing HSCT for the second time.

Treatment and study plan

STEPP Intervention

Behavioral

Peer support intervention comprised of five learning modules on psychoeducation and supportive psychotherapy strategies, via virtual platform. If participants do not have a smart device, one will be provided by the study team.

Primary outcomes

  1. Feasibility of STEPP

    Time frame: Up to 10 weeks

    The proposed STEPP intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study, and of those enrolled and randomized to the intervention, at least 60% complete at least 3/5 of the intervention sessions.

Secondary outcomes

  1. Acceptability of STEPP

    Time frame: Up to Day +60 (+/- 10 days)

    The 7-item Client Satisfaction Questionnaire (CSQ) will assess patient satisfaction with the STEPP intervention. Each question is scored from 0-4 to result in a total of 0-28. Higher scores indicate increased acceptability of the intervention.

  2. Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)

    Time frame: Up to Day +60 (+/- 10 days)

    Compare anxiety symptoms using the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A) between the two groups. The HADS-A is comprised of 7 items that quantify the degree to which participants experience mood symptoms, with each item's score ranging from 0 to 3. Scores range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant anxiety.

  3. Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)

    Time frame: Up to Day +60 (+/- 10 days)

    Compare quality of life (QOL) using the 45-item Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) between the two groups.

    The FACT-BMT consists of five subscales assessing well-being across the following domains: physical, functional, emotional, social, and bone marrow transplant symptoms. Each question is scored from 0 ("Not at all") to 4 ("Very Much"). The FACT-BMT ranges from 0 to 148, with higher scores indicating better quality of life.

  4. Depression Symptoms based on the Hospital Anxiety and Depression Scale-Depression Subscale (HADS-D)

    Time frame: Up to Day +60 (+/- 10 days)

    Compare depression symptoms using the Hospital Anxiety and Depression Scale-Depression Subscale (HADS-D) between the two groups. The HADS-D is comprised of 7 items that quantify the degree to which participants experience mood symptoms, with each item's score ranging from 0 to 3. Scores range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant depression.

  5. Post-Traumatic Stress Symptoms based on the Post-traumatic Stress Checklist-Civilian Version (PCL-C)

    Time frame: Up to Day +60 (+/- 10 days)

    Compare post-traumatic stress disorder symptoms using the 17-item Post-traumatic Stress Checklist-Civilian Version (PCL-C) between the two groups.

    The PCL-C evaluates symptoms of post-traumatic stress disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders-IV. Each item is scored from 1 to 5 for a total score ranging from 17 to 85. A higher score indicates greater severity of post-traumatic stress disorder symptoms.

  6. Social Support based on the Social Support Effectiveness Questionnaire (SSEQ)

    Time frame: Up to Day +60 (+/- 10 days)

    Compare social support using the 26-item Social Support Effectiveness Questionnaire (SSEQ) between the two groups.

    The SSEQ is a validated instrument used in the oncological population to assess patients' perception of social support. The total score ranges from 0 to 80, with higher scores indicating more effective support.

Other outcomes

  1. Self-Efficacy based on the Cancer Self-Efficacy Scale-transplant (CASE-t)

    Time frame: Up to Day +60 (+/- 10 days)

    Compare self-efficacy using the Cancer Self-Efficacy Scale-transplant (CASE-t) between the two groups.

    The CASE-t assesses patients' confidence in managing the impact of their illness. Scores range from 0 to 170, with higher scores indicating greater self-efficacy.

  2. Gratitude based on the Gratitude Questionnaire

    Time frame: Up to Day +60 (+/- 10 days)

    Compare gratitude using the 6-item Gratitude Questionnaire between the two groups.

    The Gratitude Questionnaire ranges from 6 to 42, with higher scores indicating a stronger propensity for experiencing gratitude in daily life.

  3. Positive Affect based on the Positive and Negative Affect Schedule Positive Affect Subscale

    Time frame: Up to Day +60 (+/- 10 days)

    Compare positive affect using the 10-item Positive Affect Subscale from the Positive and Negative Affect Schedule (PANAS) between the two groups.

    The Positive Affect Subscale ranges from 10 to 50, with higher scores indicating higher levels of positive affect.

  4. Flourishing based on the Flourishing Scale

    Time frame: Up to Day +60 (+/- 10 days)

    Compare flourishing using the 8-item Flourishing Scale between the two groups.

    The Flourishing Scale ranges from 8 to 56, with higher scores indicating having more psychological resources and strengths.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation (STEPP): Feasibility and Preliminary Efficacy Trial

Acronym: STEPP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2023
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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