Trial of Electronic Patient Reported Outcome Measures (ePROMs) for the collection of primary endpoints in a trial of lignocaine for the prevention of post-operative pain in breast cancer surgery.

This study aims to provide data on the reliability and acceptability of using electronically captured patient reported outcome measures (ePROMs) for the collection of primary endpoint data within the first large scale, multicentre Australian and New Zealand College of Anaesthesia (ANZCA) Clinical Trials Network (CTN) clinical trial using software provided by Research Path Pty Ltd. All participants who have consented to participate in the LOLIPOP trial (Australia only), from the commencement of ePROMS substudy and application launch, will be approached for inclusion in the substudy. This substudy aims to validate the collection of patient reported chronic post-surgical pain 12 months following surgery for a primary breast cancer diagnosis via an electronic survey, as opposed to follow up phone call by a research coordinator. For the purposes of the LOLIPOP trial, the primary endpoint is defined as: The incidence of moderate or severe Chronic Post Surgical Pain (CPSP) at 1 year after surgery, as reported by the patient at follow-up review. To meet the criteria for moderate or severe CPSP at 1 year, the reported pain: a. Must be reported to be completely or partly caused by the breast surgery undertaken 1 year ago b. Must have been present for at least 3 months c. Must be reported as of “worst” intensity =4 out of 10 in the last week on the modified Brief Pain Inventory Short Form (mBPI-SF). d. Be in the area of the breast surgery performed 1 year ago or in one of the following related areas: axilla, ipsilateral side of chest wall or ipsilateral upper arm. e. Must not be clearly and exclusively attributable to another cause such as radiation therapy at or near the pain location, repeat surgery at or near the pain location, musculoskeletal injury at or near the pain location, infection at or near the pain location or recurrence of cancer at or near the pain location. The ePROMs intervention will involve an automated email and/or SMS prompt being sent to the participant requesting the completion of the primary pain endpoint survey data via an online electronic survey. This will be triggered to send in line with the completion guidelines in the Case Report Form at the 12-month anniversary of the date of the index surgery. Weekly reminders for incomplete data will then be sent on weeks 1, 2, 3 and a final reminder sent 4 weeks following the 1-year anniversary of the index surgery. It is anticipated that the survey will take no more than 5 minutes to complete. Given the duplication of data for substudy participants, the ePROMs survey is an abridged version of the full 12 month follow up survey delivered by coordinator, designed only to validate the primary endpoint of the trial. Following this final reminder, if the data remains unanswered, the participant will be marked as lost to follow up for the purposes of the sub-analysis of ePROMs data. All participants will also receive a research coordinator phone follow up for the 'standard' collection of primary outcome data. Additional questions will be asked as part of this follow up process for those additionally enrolled in the substudy: around the ease of completion of ePROMs, any problems experienced by the participant in doing so, and the patient’s preferred method of follow-up for future research.