Abstract
BACKGROUND: Hope is defined by caregivers as the inner strength to achieve future good and to continue care giving. Pilot test findings of a Living with Hope Program (LWHP) suggested it is an acceptable and feasible intervention for use by family caregivers. Although it shows promise in potentially increasing hope and quality of life, further testing and development is needed. Questions remain as to: a) what are the mechanisms through which the LWHP affects outcomes and b) how long it is effective? The overall purpose of this time series mixed method study is the further development and testing of the LWHP by:a. Determining the mechanisms of the LWHP by testing a LWHP conceptual model in which self-efficacy, and loss/grief are hypothesized intermediary variables for changes in hope, and subsequently quality of life among rural women caring for persons with advanced cancer, and;b. Exploring the longitudinal effects of the LWHP on hope, quality of life and health services utilization among rural women caring for persons with advanced cancer. METHODS/DESIGN: Using a time-series embedded mixed method design, data will be collected from 200 rural women caregivers. Following the collection of baseline and outcome variables, the intervention (LWHP) is applied to all subjects. Subjects are followed over time with repeated measures of outcome variables (1 wk, 2 wk, 3, 6 and 12 months). The journals that are completed as part of the LWHP comprise the qualitative data. Health services utilization data will be collected from the Saskatchewan Health Administrative Database for all subjects one year prior and one year after study enrolment.Path analysis will be used to test the model post LWHP, at 1 and 2 weeks. Two-factor ANCOVA will determine patterns over time and Cortazzi's narrative analysis will be used to analyze subjects journals completed as part of the LWHP. DISCUSSION: Data Collection began January 2009 and is expected to be completed within 2 years time. Monthly meetings with data collectors and site collaborators have been instrumental in revisions to the original study protocol such as identifying and adding additional study sites. TRIAL REGISTRATION: Trial Registration; Clinical Trials.Gov. NCT01081301.