NCT00766883

Problem-Solving Education for Caregivers and Patients During Stem Cell Transplant

Completed Phase 2 Last updated 17 December 2019

What this trial tests

Phase 2 trial testing Problem Solving Education in Distress in 195 participants. Completed in 15 December 2010.

Timeline

29 September 2008

Primary endpoint
15 December 2010

15 December 2010

Quick facts

Lead sponsor	National Institutes of Health Clinical Center (CC)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	195
Start date	29 September 2008
Primary completion	15 December 2010
Estimated completion	15 December 2010
Sites	1 location across United States

Drugs / interventions tested

• Problem Solving Education

Conditions studied

• Distress — all drugs for Distress →
• Hematopoietic Stem Cell Transplantation — all drugs for Hematopoietic Stem Cell Transplantation →

Sponsor

National Institutes of Health Clinical Center (CC)

Who can join

18 and older, any sex, with Distress or Hematopoietic Stem Cell Transplantation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will examine the effectiveness of problem-solving education for patients who are undergoing a stem cell transplant and their caregivers. The emotional stress of transplant extends beyond patients to their caregivers; this study will identify the type of education that will be most helpful to transplant caregivers.

Adult patients undergoing stem cell transplant at the NIH s Clinical Center and their adult caregivers are eligible for this study. The caregiver must be caring for the patient from before hospital admission for the procedure until 6 weeks following the transplant. Both patient and caregiver must be able to read and speak English.

Patients and caregivers have three education sessions (in addition to the routine transplant education provided at the Clinical Center) and complete three study questionnaires as follows:

* Questionnaires: The questionnaires vary somewhat for patient and caregiver, but include information on demographics (e.g., sex, race, marital status, education level), distress, lifestyle, relationship with the caregiver/patient, confidence level, symptoms, pain, fatigue and sleep quality. Questionnaires are completed before the patient undergoes the transplant (and before attending any education sessions), before the patient is discharged from the hospital and 6 weeks after hospital discharge.
* Education sessions: The 60-minute sessions are designed to teach problem-solving strategies by looking at problems in a new way and learning effective communication skills. The sessions are conducted before the patient is discharged from the hospital, 1 week after discharge and 3 weeks after discharge.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Distress screening in allogeneic hematopoietic stem cell (HSCT) caregivers and patients.
   Bevans M, Wehrlen L, Prachenko O, Soeken K, et al · · 2011 · cited 53× · PMID 21626610 · DOI 10.1002/pon.1906