About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient undergoing a stem cell transplant at the University of Pittsburgh Hillman Cancer Center
18 years or older
having a family caregiver age 18 years or older also willing to participate in the study
willing to accept randomization
Disqualifiers
Prior history of stem cell transplant
Non-English speaking
Trial design
Parallel
Treatments tested in this trial
Dyadic Problem Solving Training
BehavioralDPST 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.
Supportive Care
BehavioralSupportive Care consists of providing support to the patient and family caregiver as they manage the medical regimen after stem cell transplant
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Immunosuppressant blood levels
levels of immunosuppressant medication in patient's blood
Patient health care utilization
Counts of number of hospital readmissions, emergency room visits, and unplanned medical visits
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.
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)
Other outcomes
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.
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.
clinical outcomes
presence of graft failure, graft versus host disease, and survival
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.
Sponsors and contacts
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University of Pittsburgh
Lead sponsor
National Cancer Institute (NCI)
Collaborator