Title: Bridging the Age Gap: Integration of quality of life outcomes into the decisionmaking of older women with early breast cancer
Funder: Department of Health and Social Care

Abstract: Development work questions: Determine whether stratified quality of life (QoL) and functional outcomes can be integrated into the Age Gap online decision tool to support shared decision making in older women Determine the optimal way to present QoL and functional outcome data to older women. Background: There is significant variation in the management of older women with breast cancer particularly in rates of surgery and chemotherapy. For some older women, non-standard therapy may be appropropriate and may reduce impacts on QoL and physical function with little detriment to survival. We have developed a sophisticated on-line tool, the Age Gap Decision Tool, which provides age, health and frailty stratified survival outcomes for older women with breast cancer based on highly accurate, validated statistical models (https://agegap.shef.ac.uk/). Evaluation of the tool in a cluster trial found it improved the quality of shared decision making. We wish to develop the tool to reflect the priorities of older women who value QoL and independence at least as strongly as survival. The existing tool only presents survival outcomes, which may not give women all of the decision support information they need. The Age Gap cohort study, collected prospective data from 3400 older women with breast cancer including post operative QoL and physical functional outcomes. We wish to integrate this into the online tool. Aim: To enhance the newly released Age Gap decision Tool to by integrating QoL and functional outcomes and evaluate its usability and efficacy in supporting shared decision making. Objectives: To explore the importance of QoL and physical frailty outcomes on treatment decision making in older women with operable breast cancer. To identify ways of presenting QoL and physical frailty outcome data in a way that is understandable and usable for older women facing treatment decisions for operable breast cancer. To modify the statistical model and algorithm already in existence to include QoL and functional outcomes in the online decision aid. To assess the usability of this decision aid in healthy older women and health care professionals (HCPs). Development work plan: Semi-structured interviews and focus groups with older women and HCPs to discuss the importance of QoL and functional outcomes and information presentation preferences including review of specially developed demonstration materials. Use the existing Age Gap data on QoL and functional outcomes, stratified by patient and treatment characteristics, to develop models to modify the current Age Gap decision tool. The modified decision tool will be piloted with older patients and HCPs at 5 UK units to determine usability and validity. Modifications will be made before Medicines and Health Regulatory Agency (MHRA) approval and re-launch. Timelines for delivery (months): 0-3: Regulatory approvals. 0-12: Build model 3-9: Qualitative interviews/focus groups 9-15: Tool development 15-21: Piloting. 22-24: MHRA approval, publication, presentation Anticipated impact and dissemination: Widespread use by UK clinicians will reduce adverse impacts of breast cancer treatment and improve shared decision making. Publication in high impact journals. International presentation. Social media platform engagement.

Lay abstract: Aims of the research: To adapt our existing on-line Decision Tool, which estimates the chances of survival after different treatments for breast cancer. The tool will be improved by adding in information about how treatments affect quality-of-life. This will include whether patients are able to carry out normal day to day activities after treatment. Background to the research: Older women with breast cancer may be offered non-standard treatment to help to reduce the risk of side effects. Older women are more likely to have other illnesses. They may be less able to tolerate standard treatments such as surgery, chemotherapy and radiotherapy. For some frailer older women surgery may be replaced with anti-oestrogen tablets only. Also, chemotherapy is often not offered to older women. For some older women, not having standard treatment may mean they have slightly worse survival from the cancer, but are less likely to suffer side effects. These treatments all cause drop in quality-of-life and may impact on their ability to perform their normal activities. We know that as women get older they value quality-of-life and physical function as much as life expectancy. At present, no decision tools give this information to help them weigh this up. We have already developed an online tool for older women with breast cancer that calculates survival outcomes if women have non-standard treatment compared to standard treatment. We would like to add quality-of-life outcomes into the tool and assess whether older women feel this is useful. Design and methods used: 1. Find out how older women would like to see quality-of-life outcomes displayed in the online tool. This will be done by interviewing older women either individually or in focus groups. We will use mock ups of how the quality-of-life data could be displayed to see which is best. We will also interview health care professionals. 2. We will use data from our previous study about quality-of-life after breast cancer treatment in 3400 older women to create a new model. This will be inserted into the existing tool to allow it to show quality of life and physical outcomes. 3. The new model will be tested with older women and healthcare professionals at 5 UK units to assess its value. Any changes will then be made before an updated tool is released for general patient use. Patient and Public Involvement: We have done extensive patient engagement to develop the existing tool and this project will have patient representatives on the steering committee to help with development, conduct, analysis and publication of the work. Dissemination: Dissemination and outcomes. The updated tool will be available freely on-line and will be published and presented in scientific papers, presentations and on social media.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: CANCER AND NEOPLASMS