Clinical Trial VICCBRE1301
Young and Strong: An Education and Supportive Care Intervention Study for Young Women with Breast Cancer
- Protocol No. VICCBRE1301
- Open Date: 05/07/2013
- Staging: NA
- Age Group: Adults
- Scope: National
- Objective: To Determine the effect of an education and support intervention for young women with breast cancer and their oncology providers (YWI) on attention to fertility issues compared to a physical activity comparison intervention (PAI) in a randomized controlled trial.
- Disease Sites: Breast
- Therapies: Supportive Care
- Drugs: None Specified
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: 01647607
- Secondary Protocol No: Not Specified
Sites will be randomized to the YWI or the PAI arm. After a site has been randomized and IRB approval for the study has been obtained, but prior to participant enrollment, the DFCI study team will mail printed intervention materials for providers and patients (see Section 3.4.2 for specific materials) to the Site Coordinator. All participants will be asked to complete four patient surveys during the study: a baseline survey (Appendix A1: Patient Baseline Survey) and three follow-up surveys (Appendix A2: Patient 3 month survey; Appendix A3: Patient 6 month survey; and Appendix A4: Patient 12 month survey). All survey time points will be calculated based on the date of participant enrollment. Participants will be asked to complete the brief baseline survey (Appendix A1) in clinic after providing consent but prior to receiving intervention materials. Participants will be asked to complete the follow-up surveys (Appendices A2, A3 and A4) online via SurveyGizmo, or by phone, depending on patient preference, approximately 3, 6 and 12 months post-enrollment. At the time of the baseline survey, participants will be asked to indicate their preferred method of contact for follow-up surveys (online or telephone interview). See pg. 2 of Appendix A1: Patient Baseline Survey.