Date of Award

12-1-2003

Degree Type

Restricted Access Thesis

Degree Name

Master of Science

Field of Study

Clinical Research Management

Department

Graduate School of Biomedical Sciences

First Advisor

Robert Kaman

Second Advisor

LaChelle Arredondo

Third Advisor

Robin Newman

Abstract

Oncology is an area of study that is greatly affected by time. Patients with cancer need safe and effective treatment immediately. For some, current treatments have not worked to eliminate their disease. Their recurrent condition reinforces the need for safer and more effective treatment. This treatment must not only destroy the cancerous cells, but it must also allow for the continuation of their lives. This life can be measured by time and quality. Ideally, both would be maximized for proper treatment, yet current science has not found this model cure. For some regimens, quality of life could be maximized at the expense of quantity of life and vice versa. Both the patient and the healthcare provider should evaluate the balance of expectations. The potential of each life should be maximized for length and quality. The investigator/physician must do everything in their power to ensure that the patient’s needs are met medically. In treatment involving recurrent cancer patients, time is of the essence. Therapy, in every form, must be given immediately to extend and improve their remaining lives. If QOL assessments can predict the outcome of retention, acknowledgement of the subject’s well-being can allow for greater insight into the physical and emotional effects of the experimental treatment. The use of this information can help future generations of cancer patients by providing data that describes the therapy. The study of “Long Term Subject Compliance and Withdrawal Rates in Gynecologic Oncology Clinical Research Studies” is necessary for the evaluation of QOL assessments to subject retention, patient care practices in research and private practice may be affected through incorporation of the QOL assessment. There are many benefits that may result if significance is found in this study. The main objective of the QOL assessment is to observe the QOL of the subject in relation to the effect of the treatment on the individual. If subject retention can be predicted from the evaluation of QOL assessments, future clinical research studies, in gynecologic oncology and beyond, may modify their protocols to include the assessments. Improved subject retention will ultimately improve the accuracy of data collection. Improved accuracy will help evaluate the outcomes of treatment for cancer patients. If the QOL assessment shows a correlation to subject retention, the survey could be used as a tool, not only to assess the patient’s well being, but also to predict withdrawal. This project could identify “at-risk” factors of the subject population. Subjects who are at-risk for withdrawal should be followed closely. Excluding subjects that meet the clinical protocol would be unethical. To protect the validity of the study and ensure ethical measures are taken, those subjects that have factors associated with drop-out should be enrolled in the study and monitored closely. The survey may give insight to the types of ancillary or palliative care that may be needed during the patient’s fight with cancer. This research hopes to identify that quality of life assessments are an integral dimension of the research practice. The care of the patient rests in the hands of the physicians providing treatment. They are responsible for the needs and best interest of the patients. Wide discrepancies between the rating of specific outcomes of treatment by the patient and physician have been noted in current literature. This study may help show that the patient driven quality of life assessment is an important aspect of patient care, and should be integrated as a common tool for the care of gynecologic oncology patients. The use of this tool outside of the research setting should also be explored. Future studies in quality of life, beyond that of gynecologic oncology, may be investigated. This study hopes to initiate further research for the quality of life assessment because the QOL assessment gives data regarding well-being from the patient’s perspective. Future studies should also research the confounding factors that may influence subject withdrawal. These additional collaborative factors may contribute to compliance or those “at-risk” for drop out. By maximizing subject retention and protecting subject safety, healthcare research can provide results that reflect the true investigational question.

Comments

W 4.5 K41L 2003

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