Hematopoetic Stem Cell Transplant, Hematopoetic Stem Cell Transplantation, Stem Cell Transplant
Conditions
Keywords
stem cell transplant, hematopoietic stem cell transplant
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALDyadic Problem Solving Training
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.
BEHAVIORALSupportive Care
Supportive Care consists of providing support to the patient and family caregiver as they manage the medical regimen after stem cell transplant
Sponsors
University of Pittsburgh
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Prior history of stem cell transplant * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health Habits Assessment - modified for stem cell transplant | 1-, 5-, 12- and 24-weeks post-intervention | 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 | 1-, 5-, 12- and 24-weeks post intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Immunosuppressant blood levels | 1-, 5-, 12- and 24-weeks post-intervention | levels of immunosuppressant medication in patient's blood |
| Patient health care utilization | continuous over 24 weeks post-intervention | Counts of number of hospital readmissions, emergency room visits, and unplanned medical visits |
| Patient Health Questionnaire- 9 | baseline and 1-,5-,12-, and 24-weeks post-intervention | 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 | baseline and 1-, 5-, 12-, and 24-weeks post-intervention | 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) |
| Dyadic Adjustment Scale - modified | baseline and 1-, 5-, 12-, 24-weeks post-intervention | 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. |
| Task Responsibility | 1-, 5-, 12-, and 24-weeks post-intervention | 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). |
| Caregiver Reaction Assessment | 1-, 5-, 12-, 24- weeks | Assesses burden in caregivers, 24 items rated on a 1=low to 5=high; range = 24-120; sum will be used. |
| Cancer and Treatment Distress Scale | baseline and 1-, 5-, 12-, 24-weeks post-intervention | Assess distress specific to cancer, 35 items are rated from 0=none to 3=severe; range = 0-105; sum score will be used. |
| PROMIS - 16 v2.1 | baseline and 1-, 5-, 12-, and 24-weeks post-intervention | 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. |
Countries
United States
Contacts
CONTACTDonna Posluszny, PhD
Outcome results
None listed