Abstract P4-18-01: Sharing clinical trial results with patient participants: A project of the Dana Farber/Harvard Cancer Center (DF/HCC) breast cancer research advocacy group
Authors: Frank ES , Price KN , Colten ME , Fax RG , Levine MA , Matyka C , Dowton AA , Barry WT , Winer EP , Partridge AH 
Published: August 2014

Abstract
Background: The concept of sharing the results of clinical trials with trial participants has widespread acceptance, but there has been limited work related to the process for routinely sharing such results. The Breast Cancer Patient Advocacy Group at the DF/HCC in collaboration with breast oncologists developed tools and procedures for sharing results. A protocol to assess the impact and process of offering and sharing clinical trial summary results with participants previously enrolled in a therapeutic breast cancer clinical trial was opened March, 2013.
Methods: The phase II therapeutic trial evaluated preoperative vinorelbine/trastuzumab or docetaxol/carboplatin/trastuzumab in women with HER2+ breast cancer. 60/81 women who participated in this trial (Dec 2003-Aug 2008) were invited to participate (21 excluded: 10 deceased, 5 declined further contact, 6 from external institution). The initial invitation to participate included a response form with 4 options. Upon return of this form, participants were sent the corresponding materials. To date, 45 of the 60 (75%) have responded and 31 have returned surveys.
Participation OptionReply to invitation (N = 60)Materials SentSurveys returnedWould like to receive trial results summary and take survey35 (58%)Cover letter, trial results summary, survey30Would like to take survey but NOT receive trial results summary3 (5%)Cover letter, survey1Would like to receive trial results summary only3 (5%)Cover letter, trial results summarynaNot wish to participate4 (7%)NonenaNo response15 (25%)Re-contactna
Results: Thirty participants who received the trial results summary returned the survey. Median age at time of survey was 56 (range 40-82); 57% were college graduates; and 93% were white. With regard to impact on trial participants, 100% reported they were glad to be offered the trial results. Being offered the trial results made 40% feel much more appreciated and 17% a little more appreciated. 97% felt that clinical trial results should be offered to participants when they become available. Participants also expressed concern about what they might learn from the results summary (somewhat concerned 23%, very concerned 20%), but 93% reported reading the results did not have any effect on how often they felt anxious.
With regard to the process of offering and sharing clinical trial results, 90% were satisfied with regular mail, whereas 10% would have preferred other methods (phone or email). All reported they read the entire summary, and only 3% reported reading it was not very easy. Half of the patients responded that the summary contained the kind of information they wanted/expected. Suggested improvements included providing more details, especially on recurrence and survival information.
Conclusions: Among clinical trial participants who wanted to receive a clinical trial results summary, reading the summary did not appear to have an adverse impact. Participants felt the clinical trial results summary should be more detailed. The results from this study will serve as a pilot to inform future procedures, with the goal of offering results of all breast cancer clinical trials to interested study participants at our institution.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P4-18-01.