Health TrialsbyHealthPanel

A Structured Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation

ConditionHematopoietic Stem Cell Transplantation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital

About this trial

This randomized clinical trial is evaluating the impact of a structured peer support intervention (STEPP) on psychological distress and quality of life among patients undergoing hematopoietic stem cell transplantation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (aged 18 years and older) with hematologic malignancies, scheduled to undergo autologous or allogeneic HSCT

Ability to speak, read, and respond to questions in English or Spanish to complete study procedures

Disqualifiers

Patients undergoing HSCT for benign hematologic conditions

Patients with acute or unstable psychiatric or cognitive conditions (e.g., dementia) which the treating clinicians believe prohibits informed consent or compliance with study procedures

Patients undergoing HSCT for the second time

Trial design

Design model

Parallel

Treatments tested in this trial

  • STEPP

    Behavioral

    STEPP, a phone-delivered structured peer support intervention for patients preparing to undergo hematopoietic stem cell transplantation (HSCT), consists of five sessions which integrates evidence-based strategies from cognitive-behavioral therapy, mindfulness, and positive psychology with informational, emotional, and practical support. STEPP is manualized and delivered by an HSCT survivor who is trained and supervised by a clinical psychologist.

  • Minimally Enhanced Usual Care Control

    Other intervention

    The minimally enhanced usual care control condition entail standard psychosocial care provided by social work and a comprehensive list of peer support resources available through participants academic hematopoietic stem cell transplantation centers and national organizations.

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: Structured Peer Support Program (STEPP)Experimental treatment 1 intervention
Group B: Minimally Enhanced Usual CareOther 1 intervention

Trial outcomes

Primary outcomes

1

Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale

Compare anxiety symptoms between the two groups at 8 weeks using the 7-item Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A). The HADS-A subscale score ranges from 0-21, with higher scores indicating worse anxiety symptoms.

Time frame
8 weeks (+/- 2 weeks)

Secondary outcomes

1

Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale

Compare anxiety symptoms longitudinally between the two groups using the 7-item Hospital Anxiety and Depression Scale-Anxiety (HADS-A) subscale. The HADS-A subscale score ranges from 0-21, with higher scores indicating worse anxiety symptoms.

Time frame
8 weeks to 24 weeks (+/- 2 weeks)
2

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

Compare quality of life longitudinally between the two groups using the 47-item Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT). The FACT-BMT consists of 5 subscales assessing well-being across the following domains: physical, functional, emotional, social, and bone marrow transplant symptoms. The FACT-BMT total score ranges from 0-148, with higher scores indicating better quality of life.

Time frame
Up to 24 weeks (+/- 2 weeks)
3

Patient-reported self-efficacy based on the Cancer Self-Efficacy Scale- transplant (CASE-t)

Compare self-efficacy longitudinally between the two groups using the 17-item Cancer Self-Efficacy Scale- transplant (CASE-t). The CASE-t score ranges from 0-170, with higher scores indicating higher levels of patient's confidence in managing the impacts of transplant.

Time frame
Up to 24 weeks (+/- 2 weeks)
4

Patient-reported perceived social support based on the Medical Outcomes Study-Social Support Survey (MOS-SSS).

Compare social support longitudinally between the two groups using the 19-item Medical Outcomes Study Social Support Survey (MOS-SSS). The MOS Social Support Survey score ranges from 0-100, with higher scores indicating higher levels of patient's perceived social support

Time frame
Up to 24 weeks (+/- 2 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Dana-Farber Cancer Institute

Collaborator

H. Lee Moffitt Cancer Center and Research Institute

Collaborator

Fred Hutchinson Cancer Center

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: