GIST Clinical Trial
Official title:
Yeur-Hur Lai, PhD, RN, School of Nursing, College of Medicine, National Taiwan University
Background: Long-term or life-long oral targeted therapy might also increase patients'
distress, influencing patients' cognitive and life activity function, medication adherence
and related care needs. However, very limited information has been known about patients'
experiences.
Purpose: First, to examine the changes of perceived physical and psychological distress,
functional status, medication adherence, and unmet care needs; and second, to identify
factors related to the changes of patients' medication adherence and unmet care needs by
generalized estimating equation (GEE).
Methods: This is a two-phase study. Phase I is a cross-sectional survey study, and the second
phase is a 1-year follow-up prospective longitudinal study. Eligible subjects are CML and
GIST patients newly taking oral targeted therapy. Patients will be assessed before taking the
first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively). The patients
were assessed of their (1) symptom severity, (2) psychological distress, (3) cognitive and
life activity function, (4) adherence, (5) social support, (6) unmet care needs, and (7)
background and disease-treatment information. Data will be analyzed mainly by GEE to identify
the predictors (independent variables) of the changes in medication adherence and unmet care
needs overall the 12 months, 6 time points. After the approval of IRB, research assistants in
different data collection sites will be trained for maintaining the consistency and quality
of data collection.
Expected Outcomes and Future Implications: Although CML and GIST are not the most prevalent
cancers in Taiwan, the investigators aim to use both groups of patients groups to examine the
current status and changes of distress, adherence and care needs in patients are taking
long-term or life-long TKI derived oral targeted therapy. From Phase II study, the changes of
newly TKI targeted therapy takers' distress, adherence and care needs would be carefully and
in-depth examined. It will provide health care professionals a more comprehensive picture of
the changes in patients' distress, adherence, and care needs during taking oral targeted
therapy. The results will also provide as a basis and evidence for better development a
timing and comprehensive care models to fit and increase patients' life quality during
receiving the most advanced targeted therapy.
Prospective Panel Study, a 12-month follow-up longitudinal study. Eligible subjects are newly diagnosed CML and GIST patients who need to take targeted therapy. Patients would be assessed on the time point of before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively). Before this study conducted, the institutional review board would review the study. The research nurses will approach potential participants after their patients were initial treating oral targeted therapy and invite them to enroll in the study. Potential participants would be informed of the study purposes and interview contents. After written consent is obtained, the interview will be arranged. In order to control the quality of data collection, the investigators will train these research assistants. Research training will include ethical concerns about the collection of research data, methods of approaching eligible subjects, interviewing techniques, and pilot testing of data collection. The training will provide research assistants by the PI and Co-PI of this study. Training for research assistants. ;
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