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

NCT07107165 | Recruiting

• 2 other identifiers: STUDY25020163R01CA268004
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Stem Cell Transplant; Hematopoetic Stem Cell Transplant; Hematopoetic Stem Cell Transplantation

Keywords

stem cell transplant; hematopoietic stem cell transplant

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (9)

• Immunosuppressant blood levels

  1-, 5-, 12- and 24-weeks post-intervention

• Patient health care utilization

  continuous over 24 weeks post-intervention

• Patient Health Questionnaire- 9

  baseline and 1-,5-,12-, and 24-weeks post-intervention

• Generalized Anxiety Disorder - 7

  baseline and 1-, 5-, 12-, and 24-weeks post-intervention

• Dyadic Adjustment Scale - modified

  baseline and 1-, 5-, 12-, 24-weeks post-intervention

Other Outcomes (5)

• Client Satisfaction Assessment - 8

  1-week post intervention

• Satisfaction with Telehealth Technology

  1-week post intervention

• clinical outcomes

  continuous over 24-weeks post-intervention

Study Arms (2)

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.

Behavioral: Dyadic Problem Solving Training

Supportive Care

ACTIVE COMPARATOR

Supportive Care will provide support to both the patient and family caregiver as they manage the medical regimen.

Behavioral: Supportive Care

Interventions

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.

Also known as: DPST

Dyadic Problem Solving Training (DPST)

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

Also known as: SC

Supportive Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing a stem cell transplant at the University of Pittsburgh Hillman Cancer Center
• years or older
• having a family caregiver age 18 years or older also willing to participate in the study
• willing to accept randomization

You may not qualify if:

• Prior history of stem cell transplant
• Non-English speaking

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Related Publications (2)

• 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 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.

  PMID: 34875403 BACKGROUND

MeSH Terms

Interventions

1-(di-(2-pyridyl)methylene)-5-salicylidenethiocarbonohydrazide; Palliative Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Donna Posluszny, PhD

CONTACT

412-623-5966; poslusznydm@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: August 6, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 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 Criteria: Access can be requested from PI following plan description and time frame noted above

Locations

US (1)