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

NCT ID: NCT07107165

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stem Cell Transplant Hematopoetic Stem Cell Transplant Hematopoetic Stem Cell Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Dyadic Problem Solving Training (DPST)

DPST will teach problem solving skills to both the patient and family caregiver as they manage the medical regimen.

Group Type EXPERIMENTAL

Dyadic Problem Solving Training

Intervention Type 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.

Supportive Care

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

Group Type ACTIVE_COMPARATOR

Supportive Care

Intervention Type BEHAVIORAL

Supportive Care consists of providing support to the patient and family caregiver as they manage the medical regimen after stem cell transplant

Interventions

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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.

Intervention Type 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

Intervention Type BEHAVIORAL

Other Intervention Names

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DPST SC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Donna Posluszny

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Pittsburgh Medical Center Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Donna Posluszny, PhD

Role: CONTACT

412-623-5966

Facility Contacts

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Donna Posluszny, PhD

Role: primary

412-623-5966

References

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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.

Reference Type BACKGROUND
PMID: 30022348 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34875403 (View on PubMed)

Other Identifiers

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R01CA268004

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY25020163

Identifier Type: -

Identifier Source: org_study_id

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