Rates and Predictors of Nonadherence to the Post-Allogeneic Hematopoietic Cell Transplantation Medical Regimen in Patients and Caregivers.
Donna M Posluszny, Dana H Bovbjerg, Karen L Syrjala...
https://pubmed.ncbi.nlm.nih.gov/34875403/Actively Recruiting
Led by University of Pittsburgh · Updated on 2026-04-01
208
Participants Needed
1
Research Sites
4 weeks
Total Duration
Researchers are evaluating two brief psychosocial interventions to support patients who have undergone stem cell transplant and their family caregivers in managing medical regimens after hospital discharge. This randomized clinical trial aims to find out if either intervention improves psychological well-being and health-related outcomes for both patients and caregivers. The study is led by the University of Pittsburgh and focuses on the post-discharge period following allogeneic hematopoietic cell transplantation. Participants will be randomly assigned to one of two groups the Dyadic Problem Solving Training DPST group or the Supportive Care group. Both interventions consist of four sessions delivered via live video conferencing. DPST teaches problem-solving skills to help manage the medical regimen, while Supportive Care provides emotional and practical support. Each group includes 52 patient-caregiver pairs, and the interventions aim to improve adherence and perceived task efficacy. Participants and their caregivers will complete questionnaires before the intervention and at 1, 5, 12, and 24 weeks afterward. Researchers will assess health habits, perceived task efficacy, medication levels, healthcare use, mood, anxiety, relationship adjustment, and caregiver reactions. The study includes close monitoring through repeated assessments over 24 weeks, allowing detailed evaluation of how the interventions affect daily management and well-being post-transplant.
CONDITIONS
Psychosocial and Behavioral Intervention for Stem Cell Transplant Patients and Their Family Caregivers
D
Donna Posluszny, PhD
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University of Pittsburgh
Lead Sponsor
National Cancer Institute (NCI)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | DPST (problem-solving training for patient and caregiver) | Supportive Care (standard support for patient and caregiver) |
|---|---|---|
| What it is | A behavioral intervention teaching problem-solving skills to both patients undergoing stem cell transplant and their family caregivers, designed to help them manage complex post-transplant care. | A behavioral approach focusing on general support for the patient-caregiver pair as they manage post-transplant medical care, reflecting conventional practice. |
| Role in the study | The main experimental group, which receives structured problem-solving skills training aimed at improving the ability of patients and caregivers to navigate post-transplant challenges. | The comparator group, receiving standard supportive care, functioning as the control to benchmark outcomes for the experimental arm. |
| Primary use or purpose | To help patients and their caregivers improve their skills in solving problems, ideally enhancing adherence to complex post-transplant care regimens and managing transplant-related challenges. | To offer ongoing emotional and practical support to both patient and caregiver as they cope with the demands and uncertainties of stem cell transplantation and recovery. |
| How it is given or performed | DPST involves direct teaching sessions where both the patient and caregiver learn and practice structured problem-solving methods applicable to real-life post-transplant scenarios. | Standard supportive care is delivered through regular sessions focused on providing general support and information, without specific training in problem-solving techniques. |
| Evidence status | Clinical evidence for DPST in this specific context is under investigation. Previous research highlights challenges in adherence and problem-solving in post-transplant dyads, supporting rationale but not yet demonstrating proven clinical outcomes for this program. | Supportive care for patients and caregivers is an established approach, with external research supporting its association with lower anxiety, depression, and distress during transplant, but effects on post-transplant regimen adherence remain a concern. |
| Important limitations | DPST is time-intensive, requiring both patient and caregiver engagement in structured problem-solving sessions. Its generalizability outside the trial and potential effectiveness in diverse settings remain unproven until trial results become available. | Standard supportive care may not actively teach caregivers or patients how to address new or complex problems; challenges with nonadherence to post-transplant care are still frequently reported in these settings. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person or remote)
Duration - 4 sessions
Participants receive one of two psychosocial interventions via live video conferencing to help manage the medical regimen after stem cell transplant.
4 video conferencing sessions
Duration - 24 weeks post-intervention
Participants complete questionnaires to assess health habits, task efficacy, and other psychosocial outcomes after the intervention.
Questionnaires at 1, 5, 12, and 24 weeks post-intervention
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Donna M Posluszny, Dana H Bovbjerg, Karen L Syrjala...
https://pubmed.ncbi.nlm.nih.gov/34875403/Donna M Posluszny, Dana H Bovbjerg, Karen L Syrjala...
https://pubmed.ncbi.nlm.nih.gov/30022348/University of Pittsburgh
Lead Sponsor
National Cancer Institute (NCI)
Collaborating Sponsor