The purpose of the “Young Breast Cancer Survivors” study is to determine the needs of young breast cancer survivors (less than 45 years old). The results of this needs assessment will be used to help plan the development of these services. The investigators include Dr. Donna Williams, Dr. Denise Roubion-Johnson, Dr. Xiao-Cheng Wu and Lisa Smith at LSU Health New Orleans School of Public Health. You are invited to participate in this study because you are a woman younger than 45 who has been diagnosed with breast cancer.
You will be asked to complete a survey indicating how much certain physical, marital, sexual, and other issues have applied to you at any time since your breast cancer diagnosis. The survey includes summary scales and subscales from the Cancer Rehabilitation Evaluation System (CARES)*, which is a comprehensive assessment tool. The survey is expected to take 10 minutes and the identification (ID) number that was assigned to you at random by the Louisiana Tumor Registry (LTR) will be collected (if you live in Louisiana and were sent one.) An ID number is needed to ensure that the LTR does not contact and disturb you after you have completed the survey. All patient information will be kept confidential by the LTR and separate from your survey responses.
Your participation is voluntary and the alternative is to not participate. Your refusal to participate will involve no penalty or loss of benefits to which you are otherwise entitled. You may choose to discontinue participation at any time or not answer a question without penalty or loss of benefits to which you are otherwise entitled, and your responses will remain anonymous. Nonparticipation or choosing to withdraw from the study will in no way jeopardize your relationship with this institution in the present or future. There will be no benefit in enrolling in this study, but future breast cancer patients may benefit from services designed as a result of the study. There will be no costs to you as a result of participation in this survey.
All survey data from everyone who took part in the study will be combined, ensuring anonymity. It may be possible for someone to recognize your information even without your name, but this is unlikely. There may be some anxiety or nervousness during the testing process. No direct risks are anticipated in the study.
The results of the study may be disclosed to the funding agency, the Centers for Disease Control and Prevention. If the results of the study are published, the privacy of the participants will be protected and they will not be identified in any way. The sponsor (Centers for Disease Control and Prevention), the LSUHSC-NO Institutional Review Board, and the investigators mentioned previously and their staff may inspect and/or copy your study related records for quality assurance and data analysis.
Should you have any questions, concerns, or want to be more fully informed about the nature of the research and the results of the study, please do not hesitate to contact us on weekdays from 8:00 a.m.- 4:30 p.m. at 1-888-599-1073, or at our 24 hour number, (504) 495-5227. If you have questions about your rights, or other concerns, you may contact the Chancellor of the LSU Health New Orleans at (504) 568-4801.
* Schag, C. A., & Heinrich, R. L. (1990). Development of a comprehensive quality of life measurement tool: CARES. Oncology (Williston Park), 4(5), 135-8. © CARES Consultants 1988. Available from http://www.cancer.ucla.edu/Index.aspx?page=1221