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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00766883
First received: October 3, 2008
Last updated: June 21, 2014
Last verified: June 2014
  Purpose

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.

Condition Intervention Phase
Distress
Hematopoietic Stem Cell Transplantation
Behavioral: Problem Solving Education
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial to Determine the Effectiveness of Problem Solving Education in Caregivers and Patients During Allogeneic HSCT

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To determine the effect of a PSE intervention on self-efficacy (a sense of control of oneself) in caregivers during the experience of an allogeneic HSCT.

Secondary Outcome Measures:
  • To determine the effect of a PSE intervention on self-efficacy (a sense of control of oneself) in patients during the experience of an allogeneic HSCT.

Enrollment: 195
Study Start Date: September 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Problem Solving Education
    N/A
Detailed Description:

Allogeneic hematopoietic stem cell transplantation (HSCT) generates multiple symptoms and problems that can vary in complexity. Although it seems evident that patients and caregivers experience clinically significant levels of psychological distress, few intervention studies have been explored to address this concern in this population.

Problem-solving is an essential skill for individuals to successfully cope. Increased problem-solving skill has been shown to decrease psychological distress and may improve symptom distress and health related quality of life (QOL). The COPE (Creativity, Optimism, Planning, and Expert Information) problem-solving education (PSE) intervention has demonstrated benefit and has been reported as a positive therapy by cancer patients and their families. Only one study has reported the application of this intervention in the acute care setting and our previous pilot study has been the only one done with patients and caregivers undergoing allogeneic HSCT.

Based on the findings from our pilot study and recent published reports, this study is designed to determine preliminary efficacy of problem solving education by increasing self-efficacy in caregivers during allogeneic HSCT. In addition, this study will explore factors associated with change in caregiver self-efficacy and distress such as demographics, clinical variables, mutuality, caregiver reaction, sleep quality, fatigue and health behaviors.

This is a phase two clinical trial applying a prospective repeated measure design. Subjects will be accrued to this protocol if they agree to participation in an allogeneic HSCT at the Clinical Center, NIH, are greater than 18 years old, able to read English and able to comprehend the investigational nature of the study. Patient volunteers must have at least one caregiver throughout the study period. A sample of at least 71 caregivers is needed to adequately evaluate the effectiveness of the PSE intervention. In order to achieve a sample of 71 caregivers 50 transplant patients will be recruited.

Each caregiver (and patient) will be scheduled for three individualized PSE intervention sessions (study intervention) in addition to the usual care group education. Three surveys will be administered to all study participants. The baseline questionnaires will be administered twice; once prior to allogeneic HSCT and again directly before the first PSE, at the time of initial discharge from the hospital. The post-intervention questionnaires will be administered 6 weeks post discharge. There will be no long term follow-up after the intervention period. Questionnaires include: Distress Thermometer, Family Caregiving Inventory Mutuality Scale, Health-Promoting Lifestyle Profile II, Cancer Self-Efficacy scale, Brief Symptom Inventory, Caregiver Reaction Assessment, Pittsburgh Sleep Quality Index and the Multidimensional Fatigue Symptom Inventory-Short Form. In addition, the subjects will participate in a semi-structured interview at the end of the study and the interventionist will complete a log that tracks subject attendance, session length, and discrepancy between planned and actual session date and time. Quantitative and qualitative analysis techniques will be used in this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Patients:

  • Receiving their first allogeneic HSCT at the CC, NIH.
  • Age greater than or equal to 18 years old.
  • Ability to comprehend the investigational nature of the study and provide informed consent.
  • Able to read and speak English.
  • Adult caregiver(s) available and/or living with transplant recipient.
  • Caregiver(s) agrees to participate in the study.

Caregiver(s):

  • Age greater than or equal to 18 years old.
  • Ability to comprehend the investigational nature of the study and provide informed consent.
  • Able to read and speak English.
  • Agrees to participate in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766883

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Margaret F Bevans, Ph.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00766883     History of Changes
Other Study ID Numbers: 080220, 08-CC-0220
Study First Received: October 3, 2008
Last Updated: June 21, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Allogeneic HSCT
Psychosocial Distress
Coping
Cognitive Behavior Therapy
Self Efficacy
Allogeneic Stem Cell Transplant

ClinicalTrials.gov processed this record on July 20, 2014