Title: Quantifying and implementing patient preferences for the treatment of high-risk rectal cancer, including the new strategy of organ preservation: PrefCoRe project
Funder: Department of Health and Social Care

Abstract: Background: In the UK, there are over 16,000 new cases of rectal cancer p.a. For patients with high-risk tumours, treatment includes chemo-radiotherapy (CRT) followed by major surgery. There are risks of surgical complications, long-term side-effects, and a third of patients require a permanent colostomy. In the past 5-8 years, researchers have established that rectal tumours may totally regress after CRT in up to a quarter, avoiding the need for surgery. This is a new paradigm of organ preservation . This is termed clinical complete response (cCR); where patients opt to avoid surgery, this is called watch and wait (W&W). Initially, there was nervousness that avoidance of surgical resection might compromise long-term survival. However, one of the largest studies in the world addressing this question (OnCoRe project; lead: Renehan), based in NW England, showed that this approach is safe. There is a common perception among cancer doctors that organ preservation is a good thing, but there is almost no research addressing patient preferences and, no research has investigated how people balance the characteristics of these options. Moreover, there is no patient decision aid (PtDA) to assist individuals facing this choice. Yet, PtDAs have a positive effect on patient-clinician communication and enhance quality of patient decision-making. It is likely that W&W will be an option in updated (2019) NICE guidelines: there is an imminent need to support patients through these decisions. Aims: 1. To understand the factors taken into account by patients when making a decision on rectal cancer treatments (at least three pathways) 2. To develop an user-friendly patient decision aid informed on these factors (WS2) 3. To conduct preliminary tests of the tool to understand its acceptability Methods: This proposal is a collaboration between the Renehan clinical team; health economists (HE) with expertise in discrete choice experiment (DCE) surveys; a group of investigators with expertise in building PtDAs; and patients and public involvement (PPI). Over 2 years, with a HE researcher driving the project, we will undertake three workstreams (WS). WS1: we will perform an online DCE survey to understand preferences for (i) surgery alone versus CRT followed by surgery; and (ii) where cCR occurs, the options of W&W versus surgery by presenting hypothetical treatment scenarios, described by their characteristics, to at least 100 patients and 100 public participants &ndash; accessed through internet providers and patient charities, with scope to sample up to 600. WS2: we will translate the DCE information fo build a visually animated web-based PtDA, known as &ldquo;DCIDA&rdquo;. WS3: We will test the usability of this tool, using methods such as eye-tracking and System Usability Scales, and work with clinical patterns (for example, MDT networks) to identity its position in treatment pathways. PPI With our NIHR Manchester Biomedical Research Centre PPI partners, in a pilot study, we consulted 48 individuals on treatment preferences. Results showed mixed views highlighting the need for this research. We will engage PPI at the proposed DCE and PtDA stages; and at the end of the study, on plans for dissemination of the results.

Lay abstract: Background: In the UK, there are over 16,000 new cases of rectal cancer per year. Treatment includes chemotherapy and radiotherapy, followed by major surgery, especially in those patients deemed as high-risk . There are risks of surgical complications, long-term side-effects, and about a third of patients require a permanent colostomy (a bag ). In the past 5-8 years, researchers have found that rectal tumours may totally disappear after chemo-radiotherapy in 25% patients (known as a clinical complete response), avoiding the need for surgery. This is a new type of rectal cancer management known as organ preservation . Instead of surgery, patients are actively monitored, watch-and-wait , to ensure tumours have not returned. Initially, doctors were nervous that not giving patients surgery might compromise long-term survival. However, one of the largest studies in the world addressing this question and based in NW England (the OnCoRe project; lead: Renehan), showed that this approach is safe. There is a common perception among cancer doctors that organ preservation is a good thing, but there is little research addressing patient preferences. Specifically, no research has investigated how people balance the characteristics of these treatments and make decisions. There are no decision aids for this complex treatment; yet it is known that decision aids have a positive effect on patient-clinician communication and enhance quality of patient decision-making. Aims: 1. To understand the factors taken into account by patients when making a decision on rectal cancer treatments 2. To develop an electronic patient decision aid based on these factors. The second aim is key to taking this project to benefit patients within the next few years. Methods: This is a collaboration between the Renehan clinical team; health economists (investigators with expertise in building decision aids); patients and public. Over 2 years, we will undertake two levels of research. First, an online survey to understand preferences for (i) surgery alone versus chemo-radiotherapy plus surgery; and (ii) where tumours disappear after chemo-radiotherapy, the options of watch-&-wait versus surgery by presenting hypothetical treatment scenarios, described by their characteristics, to 100 patients and 100 public participants &ndash; accessed through internet providers and charities. Second, we will translate the survey information to build a web-based decision aid, known as &ldquo;DCIDA&rdquo;. PPI We conducted two online consultations with 48 people on treatment preferences. Results showed mixed views and the need for this research. We will consult patients and the public in the development of the survey and decision aid and in plans for dissemination of results. We are supported by the NIHR Manchester Biomedical Research Centre Patient and Public Involvement team. Dissemination The tool will be promoted via relevant major charities such as Bowel Cancer UK.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: CANCER AND NEOPLASMS