Psychosocial and Behavioral Intervention for Stem Cell Transplant Patients and Their Family Caregivers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dyadic Problem Solving Training, Supportive Care.
- Who it may be relevant to
- Registry conditions: Stem Cell Transplant, Hematopoetic Stem Cell Transplant, Hematopoetic Stem Cell Transplantation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Adapting After Discharge From Allogeneic SCT: Partnering Together; Dyadic Intervention to Improve Patient-Family Caregiver Team-Based Management of the Medical Regimen After Allogeneic Hematopoietic Cell Transplantation
Overview
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
- Behavioral Dyadic 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. - Behavioral Supportive Care
Supportive Care consists of providing support to the patient and family caregiver as they manage the medical regimen after stem cell transplant
Primary outcome measures
- Health Habits Assessment - modified for stem cell transplant [Time frame: 1-, 5-, 12- and 24-weeks post-intervention]
- Perceived task efficacy [Time frame: 1-, 5-, 12- and 24-weeks post intervention]
Secondary outcome measures (9)
- Immunosuppressant blood levels [Time frame: 1-, 5-, 12- and 24-weeks post-intervention]
- Patient health care utilization [Time frame: continuous over 24 weeks post-intervention]
- Patient Health Questionnaire- 9 [Time frame: baseline and 1-,5-,12-, and 24-weeks post-intervention]
- Generalized Anxiety Disorder - 7 [Time frame: baseline and 1-, 5-, 12-, and 24-weeks post-intervention]
- Dyadic Adjustment Scale - modified [Time frame: baseline and 1-, 5-, 12-, 24-weeks post-intervention]
- Task Responsibility [Time frame: 1-, 5-, 12-, and 24-weeks post-intervention]
- Caregiver Reaction Assessment [Time frame: 1-, 5-, 12-, 24- weeks]
- Cancer and Treatment Distress Scale [Time frame: baseline and 1-, 5-, 12-, 24-weeks post-intervention]
- PROMIS - 16 v2.1 [Time frame: baseline and 1-, 5-, 12-, and 24-weeks post-intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Pittsburgh Medical Center Hillman Cancer Center — Pittsburgh
Publications
- 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. PMID 30022348
- 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. PMID 34875403
Identifiers
NCT: NCT07107165 · STUDY25020163 · R01CA268004