An interventional study of Dyadic Problem Solving Training and Supportive Care in Stem Cell Transplant, Hematopoetic Stem Cell Transplant and Hematopoetic Stem Cell Transplantation, sponsored by University of Pittsburgh. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Supportive care
Adherence to the medical regimen after stem cell transplant is challenging for both patients and their family caregivers. The investigators propose a randomized clinical trial testing two brief psychosocial interventions to determine if either improves patient and family caregiver psychosocial and health-related outcomes.
The investigators propose a randomized controlled trial testing two brief, 4 session psychosocial interventions to help patients and family caregivers better manage the time period after hospital discharge from stem cell transplant. Patients and family caregivers will be randomized to either the skill learning intervention (n=52 patient-family caregiver dyads) or to the supportive care intervention (n=52 patient-family caregiver dyads). The intervention will be conducted via live video conferencing. Patients and family caregivers will complete questionnaires before the intervention and at 1-, 5-, 12-, 24 weeks afterwards. The investigators will determine whether the skills learning group has improved outcomes, including adherence to the medical regimen and perceived task efficacy.
University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
DPST will teach problem solving skills to both the patient and family caregiver as they manage the medical regimen.
Behavioral: Dyadic Problem Solving Training
Supportive Care will provide support to both the patient and family caregiver as they manage the medical regimen.
Behavioral: Supportive Care
DPST consists of teaching the patient and family caregiver problem-solving skills that they can apply to help them manage the medical regimen after stem cell transplant.
Also known as: DPST
Supportive Care consists of providing support to the patient and family caregiver as they manage the medical regimen after stem cell transplant
Also known as: SC
Health Habits Assessment - modified for stem cell transplant
Assess levels of adherence to the post-transplant multi-component medical regimen of 20 main tasks; each task marked as yes = 1/no=0 adherent. Tasks will be grouped and summed into categories including medication taking (3 items, range 0=low to 3 high), infection precautions (6 items; range 0=low to 6 high), catheter/port care (4 items, range 0=low to 4 = high), and lifestyle behaviors (7 items, range 0=low to 7=high). Higher scores indicate greater adherence.
Time frame: 1-, 5-, 12- and 24-weeks post-intervention
Perceived task efficacy
Assesses perceptions of efficacy to complete tasks of the post-transplant multi-component medical regimen, 20 items rated on 1=low to 10=high scale, mean score will be used.
Time frame: 1-, 5-, 12- and 24-weeks post intervention
Immunosuppressant blood levels
levels of immunosuppressant medication in patient's blood
Time frame: 1-, 5-, 12- and 24-weeks post-intervention
Patient health care utilization
Counts of number of hospital readmissions, emergency room visits, and unplanned medical visits
Time frame: continuous over 24 weeks post-intervention
Patient Health Questionnaire- 9
Assesses symptoms of depression, 9 items rated on 4-point scale from 0=not at all to 3=nearly every day. Sum and categorical classification will be used (score 10-14=moderate; score 15 and higher =severe.
Time frame: baseline and 1-,5-,12-, and 24-weeks post-intervention
Generalized Anxiety Disorder - 7
Assesses symptoms of anxiety, 7 items rated from 0=not at all to 3=nearly every day. Sum and category will be used (score 10-14 = moderate; score 15 or higher = severe)
Time frame: baseline and 1-, 5-, 12-, and 24-weeks post-intervention
Dyadic Adjustment Scale - modified
Assess relationship quality, 9 items rated from 1=not at all to 5 = often; range 9-45; sum will be used. Higher scores indicate greater relationship quality.
Time frame: baseline and 1-, 5-, 12-, 24-weeks post-intervention
Task Responsibility
Rating of whether the patient was mostly responsible, the caregiver was mostly responsible, or the patient and caregiver had equal responsibility in making sure each task of the post-transplant multi-component medical regimen is completed. Levels of each of the three choices will be tabulated. The highest level will dictate the categorical score (patient mostly responsible; caregiver mostly responsible; patient and caregiver equally responsible).
Time frame: 1-, 5-, 12-, and 24-weeks post-intervention
Caregiver Reaction Assessment
Assesses burden in caregivers, 24 items rated on a 1=low to 5=high; range = 24-120; sum will be used.
Time frame: 1-, 5-, 12-, 24- weeks
Cancer and Treatment Distress Scale
Assess distress specific to cancer, 35 items are rated from 0=none to 3=severe; range = 0-105; sum score will be used.
Time frame: baseline and 1-, 5-, 12-, 24-weeks post-intervention
PROMIS - 16 v2.1
Assesses overall health-related quality of life and functioning, 16 items rated from 1=low to 5 = high; higher scores indicate greater health-related quality of life; sum will be used.
Time frame: baseline and 1-, 5-, 12-, and 24-weeks post-intervention
Client Satisfaction Assessment - 8
Ratings of satisfaction with the intervention, 8 items, rating scale from 1 (low) to 4 (high). Sum of ratings on each item will be used with higher scores indicating greater satisfaction.
Time frame: 1-week post intervention
Satisfaction with Telehealth Technology
assess satisfaction with telehealth services, 2 items rated on 1=low to 7=high scale range = 2-14; sum will be used.
Time frame: 1-week post intervention
clinical outcomes
presence of graft failure, graft versus host disease, and survival
Time frame: continuous over 24-weeks post-intervention
Lack of Attention from Health Care Professionals
A four-item subscale of the Cancer Caregiving Tasks, Consequences of Needs scale. Items have five possible responses: always/most days = 4; mostly=3; only sometimes=2; rarely/never=1, and don't know/not relevant=0. Items are summed to make a total score; higher score indicates more attention from health care professionals.
Time frame: 1-, 5-, 12- and 24-weeks post-intervention
Worry about mistakes
1 item specifying how worried are you about making a mistake or unintentionally hurting the patient while caring for him/her. Responses include 1=very worried; 2=somewhat worried; 3=only a little; 4=not at all. Lower responses indicate greater worry.
Time frame: 1-, 5-, 12- and 24-weeks post-intervention
Plan to share: Yes — The study database will be reviewed to ensure that no identifying information of any type is contained therein. A downloadable, de-identified data set and data dictionary will be made available electronically from the PI after the request is reviewed by the research team for scientific merit and requestors provide evidence to the PI that (a) their plan for the use of such data has been approved by their institution's Institutional Review Board or its equivalent, and (b) they have completed NIH requirements for training in research integrity and human subjects protection.
Supporting information: Study protocol, Sap
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Pittsburgh