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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA268004 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dyadic Problem Solving Training (DPST) | Experimental | DPST will teach problem solving skills to both the patient and family caregiver as they manage the medical regimen. |
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| Supportive Care | Active Comparator | Supportive Care will provide support to both the patient and family caregiver as they manage the medical regimen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dyadic Problem Solving Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 1-, 5-, 12- and 24-weeks post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Immunosuppressant blood levels | levels of immunosuppressant medication in patient's blood | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-week post intervention |
| Satisfaction with Telehealth Technology |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Donna Posluszny, PhD | Contact | 412-623-5966 | poslusznydm@upmc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center Hillman Cancer Center | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30022348 | Background | Posluszny DM, Bovbjerg DH, Syrjala KL, Agha M, Dew MA. Correlates of anxiety and depression symptoms among patients and their family caregivers prior to allogeneic hematopoietic cell transplant for hematological malignancies. Support Care Cancer. 2019 Feb;27(2):591-600. doi: 10.1007/s00520-018-4346-3. Epub 2018 Jul 19. | |
| 34875403 | Background | Posluszny DM, Bovbjerg DH, Syrjala KL, Agha M, Farah R, Hou JZ, Raptis A, Im AP, Dorritie KA, Boyiadzis MM, Dew MA. Rates and Predictors of Nonadherence to the Post-Allogeneic Hematopoietic Cell Transplantation Medical Regimen in Patients and Caregivers. Transplant Cell Ther. 2022 Mar;28(3):165.e1-165.e9. doi: 10.1016/j.jtct.2021.11.020. Epub 2021 Dec 4. |
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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.
To provide the investigators adequate time to prepare and submit the majority of publications likely to result from the research, data obtained from the study will be made publicly available no sooner than 18 months after the conclusion of the study.
Access can be requested from PI following plan description and time frame noted above
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| Supportive Care | Behavioral | Supportive Care consists of providing support to the patient and family caregiver as they manage the medical regimen after stem cell transplant |
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| 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. | 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) | 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. | 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). | 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. | 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. | 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. | baseline and 1-, 5-, 12-, and 24-weeks post-intervention |
assess satisfaction with telehealth services, 2 items rated on 1=low to 7=high scale range = 2-14; sum will be used. |
| 1-week post intervention |
| clinical outcomes | presence of graft failure, graft versus host disease, and survival | 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. | 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. | 1-, 5-, 12- and 24-weeks post-intervention |
| ID | Term |
|---|---|
| C066715 | 1-(di-(2-pyridyl)methylene)-5-salicylidenethiocarbonohydrazide |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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