Hematopoietic Stem Cell Transplantation Clinical Trial
Official title:
A Phase II Clinical Trial to Determine the Effectiveness of Problem Solving Education in Caregivers and Patients During Allogeneic HSCT
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.
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.
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