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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Prior history of stem cell transplant

Non-English speaking

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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

Treatment groups

208 Participants
are divided into 2 treatment groups
Group A: Dyadic Problem Solving Training (DPST)Experimental treatment 1 intervention
Group B: Supportive CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1-, 5-, 12- and 24-weeks post-intervention
2

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.

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

Secondary outcomes

1

Immunosuppressant blood levels

levels of immunosuppressant medication in patient's blood

Time frame
1-, 5-, 12- and 24-weeks post-intervention
2

Patient health care utilization

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

Time frame
continuous over 24 weeks post-intervention
3

Patient Health Questionnaire- 9

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.

Time frame
baseline and 1-,5-,12-, and 24-weeks post-intervention
4

Generalized Anxiety Disorder - 7

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)

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

Other outcomes

1

Client Satisfaction Assessment - 8

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.

Time frame
1-week post intervention
2

Satisfaction with Telehealth Technology

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

Time frame
1-week post intervention
3

clinical outcomes

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

Time frame
continuous over 24-weeks post-intervention
4

Lack of Attention from Health Care Professionals

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.

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

Sponsors and contacts

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University of Pittsburgh

Lead sponsor

National Cancer Institute (NCI)

Collaborator