Grant Details
Grant Number: |
5R01NR005332-04 Interpret this number |
Primary Investigator: |
Dow, Karen |
Organization: |
University Of Central Florida |
Project Title: |
Quality of Life Intervention in Breast Cancer Survivors |
Fiscal Year: |
2004 |
Abstract
DESCRIPTION (provided by applicant): Problems that negatively affect quality of
life (QOL) are a major concern among more than 1.7 million breast cancer
survivors in the United States. QOL is considered a multidimensional construct
that incorporates dimensions of physical, psychological, social, and spiritual
well-being. The purpose of this study is to test the effectiveness of an
individualized, multidimensional quality of life intervention (Breast Cancer
Educational Intervention [BCEI]) on QOL for women with newly diagnosed, early
stage I or II breast cancer in the first year after initial treatment. The BCEI
is based on extensive preliminary research studies by the investigators. The
five selected QOL problems of fatigue, pain, fear of recurrence, sexuality
concerns, and meaning in illness were targeted as high priority areas based on
a preliminary study of 298 breast cancer survivors. The specific aim of this
study is to test the effectiveness of the Breast Cancer Educational
Intervention (BCEI). Three hypotheses will be tested: H1: Breast cancer
survivors will experience improved QOL as a result of the BCEI. H2: Breast
cancer survivors will experience improved QOL in the domains of physical,
psychological, social, and spiritual well-being as a result of the BCEI. H3:
The effects of the BCEI will be retained over time. The conceptual framework is
grounded in the City of Hope Quality of Life Model and principles of cancer
patient education. A two-group, repeated measures experimental design with a
waiting control group will be used to answer the study aims and research
questions. A sample of 250 women with newly diagnosed, early-stage I and II
breast cancer who are completing treatment will be recruited from two clinical
sites in Florida (M.D. Anderson Cancer Center Orlando) and California (City of
Hope National Medical Center). Subjects will be randomly assigned to the
Experimental or Waiting Control Group. The BCEI consists of a structured and
individualized QOL teaching and skills development program delivered by
advanced practice nurses using face-to-face instruction and reinforced with
written materials and audiotapes. The BCEI will be administered in three
face-to-face visits with three telephone reinforcements, and three evaluation
visits. Data collection will occur at three time points for the Experimental
Group and four time points for the Waiting Control Group using standardized
instruments. Data analysis will use multivariate t-test for two groups
(equivalent to MANOVA), and the generalized estimating equation (GEE) model.
Study findings are expected to improve our understanding of the incidence of
major QOL problems affecting breast cancer survivors, identify individually
selected interventions and their effectiveness, and determine
theoretically-based interventions that are realistic for implementation by
clinicians who provide follow up teaching, support, and surveillance of breast
cancer survivors.
Publications
None