Psychosocial and Behavioral Intervention for Stem Cell Transplant Patients and Their Family Caregivers

Not Applicable

Recruiting

• Conditions: Stem Cell Transplant; Hematopoetic Stem Cell Transplant; Hematopoetic Stem Cell Transplantation

• Registration Number: NCT07107165
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-17
• Study First Submitted QC: 2025-07-30
• Last Update Submitted: 2025-07-30
• Study First Posted: 2025-08-06
• Last Update Posted: 2025-08-06
• Primary Completion: 2027-06
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

• Patient scheduled for 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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)
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).
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.

Trial Locations

Locations (1)

University of Pittsburgh Medical Center Hillman Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States