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Surgery is the primary component of curative treatment for patients with rectal cancer. However, patients with a clinical complete response (cCR) after neo-adjuvant treatment may avoid the morbidity and mortality of radical surgery. An organ-sparing strategy (watchful waiting) could be an oncological equivalent alternative. Comparing different treatment strategies could induce decisional conflicts to the patients. Therefore, shared-decision making between the patient and the health care professional (HCP) should take place. Shared-decision making can be facilitated by a patient decision aid (PtDA). PtDAs aim to support the patient in making thoughtful choices among treatment options and encourage the patient to take an active role in treatment-related decisions. The aim of this study was to develop a PtDA for rectal cancer patients who reach a cCR after neo-adjuvant treatment.

We developed a PtDA prototype based on a literature review and the key elements of the Ottawa Decision Support Framework. Additionally, a qualitative study was performed to review and evaluate the PtDA. An expert panel of HCP experienced in rectal cancer treatment evaluated the information for content validity using a modified Delphi procedure. For each criterion, consensus was defined as a 78% agreement. Former rectal cancer patients were also interviewed to assess acceptability, usability, clarity and patients’ information needs.

A large consensus was reached after the first Delphi round (response rate of 52%) with an item-level content validity index (I-CVI) of 0.85-1. Eleven patients were interviewed and most of them indicated that using a PtDA in clinical practice would be of added value in the decision making. Patients reported that a lot of information is given during outpatient clinics, much of which is lost. The use of a PtDA would allow the patient to review the information at home. Patients indicated that their decisional needs are centred on the impact of side effects on their quality of life and the outcome of options. Timing on when to deliver the PtDA varied (i.e. at diagnosis or after restaging). Patients made a few comments concerning lay-out, language (use of medical terms) and missing information. The PtDA was modified taking into account the remarks of patients and HCP and a second Delphi round was held. The second round (response rate of 55%) showed again a large consensus (I-CVI 0.87-1).

We developed a PtDA to support informed, values-based decision making for rectal cancer patients. This could be an acceptable and valuable tool to help patients make informed treatment choices and as an adjunct to the physician consultation. The effectiveness and implementation of this tool will be studied in future research.