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NCT00766883 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Hematopoietic Stem Cell Transplantation and Distress, sponsored by National Institutes of Health Clinical Center (CC).

Completed
Registry status
Phase 2
Development phase
195
Enrollment target
1
Study location

NCT00766883 is a Phase 2 study of Hematopoietic Stem Cell Transplantation and Distress that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 195 participants, below the 9,782-participant average among 26 other Hematopoietic Stem Cell Transplantation trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00766883, a Phase 2 study of Hematopoietic Stem Cell Transplantation and Distress, has completed, sponsored by National Institutes of Health Clinical Center (CC).

COMPLETED
Registry status
Phase 2
Development phase
195 participants
Enrollment target
1
Study location

Study Summary

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.

Interventions

  • BEHAVIORAL Problem Solving Education

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda

Trial Details

FieldValue
Enrollment Target 195 participants
Start Date 2008-09-29
Est. Completion 2010-12-15
Phase Phase 2

What the Registry Record Tells You About NCT00766883

The ClinicalTrials.gov registry entry for NCT00766883 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 9,782-participant average among 26 other Hematopoietic Stem Cell Transplantation trials with a reported enrollment target (98% lower). The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Hematopoietic Stem Cell Transplantation appearing as the primary indexed condition, and to 1 intervention - of which Problem Solving Education is the first listed.

NCT00766883 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00766883 about?

NCT00766883 is a clinical study titled "Problem-Solving Education for Caregivers and Patients During Stem Cell Transplant". 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...

What is the current status of trial NCT00766883?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 195 participants. The study started on 2008-09-29. Estimated completion is 2010-12-15.

What conditions does trial NCT00766883 study?

This clinical trial studies the following conditions: Hematopoietic Stem Cell Transplantation, Distress.

What interventions are being tested in trial NCT00766883?

The interventions under investigation include: Problem Solving Education (BEHAVIORAL).

Who is sponsoring clinical trial NCT00766883?

This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00766883 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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