Supporting Shared Decision-making About Surveillance After Breast Cancer With Personalized Recurrence Risk Calculations: Development of a Patient Decision Aid Using the International Patient Decision AIDS Standards Development Process in Combination With a Mixed Methods Design

Abstract

Background Although the treatment for breast cancer is highly personalized, posttreatment surveillance remains one-size-fits-all: annual imaging and physical examination for at least five years after treatment. The INFLUENCE nomogram is a prognostic model for estimating the 5-year risk for locoregional recurrences and second primary tumors after breast cancer. The use of personalized outcome data (such as risks for recurrences) can enrich the process of shared decision-making (SDM) for personalized surveillance after breast cancer. Objective This study aimed to develop a patient decision aid (PtDA), integrating personalized risk calculations on risks for recurrences, to support SDM for personalized surveillance after curative treatment for invasive breast cancer. Methods For the development of the PtDA, the International Patient Decision Aids Standards development process was combined with a mixed methods design inspired by the development process of previously developed PtDAs. In the development, 8 steps were distinguished: establishing a multidisciplinary steering group; definition of the end users, scope, and purpose of the PtDA; assessment of the decisional needs of end users; defining requirements for the PtDA; determining the format and implementation strategy for the PtDA; prototyping; alpha testing; and beta testing. The composed steering group convened during regular working-group sessions throughout the development process. Results The “Breast Cancer Surveillance Decision Aid” consists of 3 components that support the SDM process: a handout sheet on which personalized risks for recurrences, calculated using the INFLUENCE-nomogram, can be visualized and which contains an explanation about the decision for surveillance and a login code for a web-based deliberation tool; a web-based deliberation tool, including a patient-reported outcome measure on fear of cancer recurrence; and a summary sheet summarizing patient preferences and considerations. The PtDA was assessed as usable and acceptable during alpha testing. Beta testing is currently ongoing. Conclusions We developed an acceptable and usable PtDA that integrates personalized risk calculations for the risk for recurrences to support SDM for surveillance after breast cancer. The implementation and effects of the use of the “Breast Cancer Surveillance Decision Aid” are being investigated in a clinical trial.

Regularly scheduled physical examinations and the detection of breast cancer recurrences

“…Strategies are required to better establish which patients are at higher risk of recurrence, and whether tailored follow-up based on recurrence risk would improve the value of follow-up. Follow-up models currently under investigation include the use of personalized outcome data in shared decision making and on-demand follow-up [ 18 , 19 ]. In addition, more data is needed on whether or not follow-up strategies are meeting the broader goals of follow-up beyond detection of breast cancer recurrence and second primary tumours but also on goals such as; patient adherence to mammography, compliance to endocrine therapy and management of psychosocial stress for example [ 14 , 15 ].…”

Evaluation of the Implementation of the Dutch Breast Cancer Surveillance Decision Aid including Personalized Risk Estimates in the SHOUT-BC Study: A Mixed Methods Approach

“…Mixed methods were used to perform the process evaluation. This evaluation was embedded within the SHOUT-BC study (see Figure 1 for a graphic overview of the SHOUT-BC study) [10,18,19]. This study was conducted in accordance with local laws and regulations.…”

“…The BCS-PtDA was developed in cocreation with relevant stakeholders and consists of three components [10]: (1) a handout sheet with which post-treatment surveillance can be introduced and on which personalized risks for recurrences (estimated using the IN-FLUENCE 2.0 nomogram, https://www.evidencio.com/models/show/2238/nl (accessed…”

“…The BCS-PtDA was developed in cocreation with relevant stakeholders and consists of three components [10]: (1) a handout sheet with which post-treatment surveillance can be introduced and on which personalized risks for recurrences (estimated using the INFLU-ENCE 2.0 nomogram, https://www.evidencio.com/models/show/2238/nl (accessed on 30 December 2023)) can be visualized, (2) a web-based deliberation tool including patient information and the 6-item Cancer Worry Scale [21], and (3) a summary sheet that can support the final decision-making during the clinical consultation (Figure 2). on 30 December 2023)) can be visualized, (2) a web-based deliberation tool including patient information and the 6-item Cancer Worry Scale [21], and (3) a summary sheet that can support the final decision-making during the clinical consultation (Figure 2).…”

“…There is evidence that SDM with a PtDA can improve patient satisfaction, adherence to treatment, and support the choice of more conservative treatment options [9]. The Breast Cancer Surveillance Decision Aid (BCS-PtDA) was developed to support decision-making for four separate decisions regarding the organization of post-treatment surveillance for breast cancer survivors: (1) surveillance frequency, (2) duration, (3) examinations, and (4) how results of examinations will be discussed [10]. The BCS-PtDA incorporates personalized risk information from the INFLUENCE 2.0 nomogram [1,2], a validated prognostic model that provides personalized estimates of the 5-year risk for developing LRRs, SPs, and distant metastases during post-treatment surveillance.…”