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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
208
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.
Supportive Care consists of providing support to the patient and family caregiver as they manage the medical regimen after stem cell transplant
University of Pittsburgh Medical Center Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
RECRUITINGHealth 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)
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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