Abstract OT3-08-01: Interview data from women contemplating LORIS trial entry during the feasibility study
Authors: Fallowfield LJ , Matthews L , Jenkins VA , May SF , Francis A , Rae D , Wallis M 
Published: February 2018

Background: LORIS is a multi-centre, randomised (1:1) controlled trial of Surgery v Active Monitoring with annual mammography in patients with low risk ductal carcinoma in situ (DCIS). During a 2 year Feasibility Study potential patients were invited to complete the Clinical Trials Questionnaire (CTQ)1 and participate in a semi structured telephone interview about the verbal, written and DVD based trial information. The DVD was produced to complement the patient information sheet (PIS) and incorporates simple graphics and a Q&A session with women asking the Chief Investigator questions about the trial.

Aims:To examine the reasons for trial participation/rejection and obtain feedback about the clarity, timing and usefulness of the PIS and DVD in order to identify potential communication drivers and barriers to trial recruitment.

Methods: Participants completed the CTQ1 prior to randomisation and with their consent were contacted following randomisation for an interview. Women declining the trial were issued with an optional pack containing the CTQ1 and the researchers' contact details if they wanted an interview. The CTQ1 comprises16 reasons that might influence a decision to either accept or decline a trial. For each statement participants register their agreement or disagreement on a scale of 1 (strongly agree) to 5 (strongly disagree) and indicate the most important reason for their decision. Interviews explored factors such as, attitudes about randomisation, and usefulness of the trial information provided.

Results: 41 patients were randomised during feasibility; 20 surgery, 21 active monitoring, 16 patients declined the trial. 40/41(98%) acceptors and 9/16 (56%) decliners completed the CTQ1. The main reason for joining LORIS was:- “I thought the trial offered the best treatment available” 13/40 (32%) and for decling the trial was “The idea of randomisation worried me” (4/9; 44%).

35 interviews were conducted (31/41 (76%) accepted and 4/16 (25%) declined LORIS). At interview acceptors commented that the PIS was very useful and clear (84%; 26/31 & 90%; 28/31, respectively). 74% (23/31) of women who joined LORIS watched the DVD and the majority (19/23; 83%) found it “very useful” and 22 (22/23; 96%) “very easy to understand”. A third of women (10/31) said the PIS and the DVD helped them decide to participate in LORIS. Women who declined the trial had clear treatment preferences; 2/4 did not watch the DVD. Three quarters of women interviewed (19/25) watched the DVD with family members/friends and found it reassuring. One commented it was “Put in words you can understand and not be baffled by”. The most popular aspect was the Q&A session (13/25; 52%).

Conclusions:The LORIS DVD was a useful, easy to understand recruitment tool, complementing the PIS. Many women felt reassured that the content was consistent with, and added to that provided by healthcare professionals. Opinions of family and friends, worries about randomisation and personal preferences exert an influence of those declining these types of trial.

Fallowfield LJ, Jenkins V, et al. (1998) Attitudes of patients to randomised clinical trials of cancer therapy. Eur J Cancer 34(10):1554–1559.

Citation Format: Fallowfield LJ, Matthews L, Jenkins VA, May SF, Francis A, Rae D, Wallis M. Interview data from women contemplating LORIS trial entry during the feasibility study [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr OT3-08-01.