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NCT Number: NCT07107165

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location status: Recruiting

Location contact

Donna Posluszny, PhD

CONTACT

[email protected]

412-623-5966

Donna Posluszny, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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

Other names: SC

Primary outcomes

  1. Health Habits Assessment - modified for stem cell transplant

    Time frame: 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.

  2. Perceived task efficacy

    Time frame: 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 outcomes

  1. Immunosuppressant blood levels

    Time frame: 1-, 5-, 12- and 24-weeks post-intervention

    levels of immunosuppressant medication in patient's blood

  2. Patient health care utilization

    Time frame: continuous over 24 weeks post-intervention

    Counts of number of hospital readmissions, emergency room visits, and unplanned medical visits

  3. Patient Health Questionnaire- 9

    Time frame: 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.

  4. Generalized Anxiety Disorder - 7

    Time frame: 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)

  5. Dyadic Adjustment Scale - modified

    Time frame: 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.

  6. Task Responsibility

    Time frame: 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).

  7. Caregiver Reaction Assessment

    Time frame: 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.

  8. Cancer and Treatment Distress Scale

    Time frame: 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.

  9. PROMIS - 16 v2.1

    Time frame: 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.

Other outcomes

  1. Client Satisfaction Assessment - 8

    Time frame: 1-week post intervention

    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.

  2. Satisfaction with Telehealth Technology

    Time frame: 1-week post intervention

    assess satisfaction with telehealth services, 2 items rated on 1=low to 7=high scale range = 2-14; sum will be used.

  3. clinical outcomes

    Time frame: continuous over 24-weeks post-intervention

    presence of graft failure, graft versus host disease, and survival

  4. Lack of Attention from Health Care Professionals

    Time frame: 1-, 5-, 12- and 24-weeks post-intervention

    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.

  5. Worry about mistakes

    Time frame: 1-, 5-, 12- and 24-weeks post-intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Donna Posluszny, PhD

CONTACT

[email protected]

412-623-5966

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2025
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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