Background:
The purpose of this study is to explore the thoughts and feelings of women diagnosed with ovarian cancer regarding inclusion in, or exclusion from, drug trials and other cancer research.  The perceived meaning of inclusion and exclusion criteria may be very different to the researcher and the research participant.  Understanding the physical, economic, and psycho-social impact resulting from participation, or being denied participation, as a study participant can guide the researcher in planning rigorous yet humanistic protocols.
Ovarian cancer is the fifth leading cause of cancer death in women and the most deadly of the gynecologic cancers. Due to inadequate screening procedures and diagnostic tools, the disease may not be identified until it is quite advanced.  In the United States alone, 20,000 women will be diagnosed annually and more than 15,000 women will die within five years of diagnosis (American Cancer Society, 2006).  Even with the advances in cancer diagnosis and therapy, the incidence and death rate in the Western world continues to rise.
Few women diagnosed with ovarian cancer receive the benefit of quality, cutting edge healthcare by a gynecologic oncologist and the opportunity to participate in clinical trials.  Oftentimes, women participating in cancer drug trials do so because the gold standard for treatment has failed or the women do not have the financial means to access other forms of treatment.  While it is clear to the researcher why inclusion and exclusion are essential to rigorous research, ovarian cancer survivors commonly express a lack of understanding, anger, and indignation at being excluded or denied participation in drug trials
Methods:
A phenomenological approach employing online (or mailed) surveys has been designed to elicit qualitative data to address the following overarching research questions:

• What has your experience been with research protocols since being diagnosed with ovarian cancer?
  
• What do the phrases “inclusion criteria” and “exclusion criteria” mean to you?
  

Study participants must be (1) diagnosed with ovarian cancer, (2) 18 years or older, and (3) able to read, write, and speak English. Snowball sampling was used to recruit participants. Paper copies of the survey were made available for potential participants without internet access.  Enrollment of study participants will continue until common themes and patterns emerge.  Completion of the survey implies consent.  Colaizzi’s method of qualitative data analysis was used to interpret the study responses. 
Preliminary Findings:

• Women with ovarian cancer express anger, frustration, and feelings of abandonment when denied the opportunity to participate in promising clinical trials.
  
• The concepts of study inclusion and exclusion are poorly understood in the general population and lead to feelings that they are “not good enough” or that they are being denied a last opportunity for survival.
  

Conclusions and Recommendations for Practice:

• Health care providers need to educate women and their families regarding inclusion and exclusion criteria and offer additional support to those excluded from studies.
  
• Propose policy changes that would enable women to access experimental cancer drugs regardless of their qualifications to participate in a specific clinical trial