Patient's Choice in the Reduction of Their Treatment in Women Over 65 Year With Breast Cancer

Collection of final treatment (WBRT, IORT or no RT) to check for potential changes after the decision was made

The patients must indicate the level of importance of the delivered information to decide their treatment strategy option by assigning a score from 0 to 10 (ie, duration of the surgery, number of radiotherapy sessions, need for additional medical examinations ...)

This encounter decision aid has been developed in collaboration with patients, radiation oncologists, communication specialists, and the US research team who developed the first EDAs. The developed EDA presents the main similarities and differences between the 3 treatment options using the main reasons to choose or decline therapeutic de-escalation elicited by the preliminary qualitative study and by previous literature on patients' preferences and information needs.

The G-CODE is a minimum set of geriatric data to be collected in cancer trials. It was developed after a Delphi consensus method with international agreement. The G-CODE has ten tools/items and a median completion time of 9 min. It allows for a minimal geriatric description of the older cancer population and standardization of geriatric data, enabling comparison across trials. The items within the G-CODE are the following: (1) social assessment: living alone or support requested to stay at home; (2) functional autonomy: Activities of Daily Living (ADL) questionnaire and short instrumental ADL questionnaire; (3) mobility: Timed Up and Go test; (4) nutrition: weight loss during the past 6 months and body mass index; (5) cognition: Mini-Cog test; (6) mood: mini- Geriatric Depression Scale and (7) comorbidity: updated Charlson Comorbidity Index. The total scale range 0-62. High score indicate better condition.

The Single Item Literacy Screener (SILS) is a single item instrument designed to identify patients who need help with reading health-related information. The instrument asks one question "How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?" with possible responses ranging from "1" (never) to "5" (always). The authors identified the cut-off point as "2" in order to capture all patients potentially in need of assistance.

The Control Preferences Scale (CPS) was developed to measure a construct that emerged from a grounded theory of how treatment decisions are made among people with life-threatening illnesses. The control preferences construct is defined as "the degree of control an individual wants to assume when decisions are being made about medical treatment." The CPS consists of five cards that each portrays a different role in treatment decision-making using a statement and a cartoon. These roles range from the individual making the treatment decisions, through the individual making the decisions jointly with the physician, to the physician making the decisions. The CPS involves subjects in making a series of paired comparisons to provide their total preference order over the five cards. These preference orders are analyzed using unfolding theory to determine the distribution of preferences in different populations and the effect of covariates on consumer preferences.

The nine-item Fear of Cancer Recurrence Inventory is a short form of the FCRI (nine-item FCRI) and corresponds to the severity subscale of the FCRI (42 items). The nine-item FCRI evaluates the presence and severity of intrusive thoughts associated with FCR. Each item is rated on a Likert scale ranging from 0 ("not at all" or "never") to 4 ("a great deal' or "all the time")

CollaboRATE is a brief patient survey focused on shared decision making. The CollaboRATE questions are as follows: (i) How much effort was made to help you understand your health issues? (ii) How much effort was made to listen to what matters most to you about your health issues? (iii) How much effort was made to include what matters most to you in choosing what to do next? CollaboRATE survey data included responses to the three CollaboRATE questions, each on a 0-9 scale, along with each respondent's age, gender and clinician

VICAN is a French national survey on life conditions of cancers survivors. In particular, the objectives are to study the labour market outcomes, the effect of cancer on an individual's employability, the psychosocial conditions impact (ie, lifestyle behaviours, perceived discrimination, family and social support) and to evaluate the physical, psychological and social needs.

The Decisional Conflict Scale (DCS) is a self-administered questionnaire that can be used to 1) diagnose a patient's decisional conflict; 2) identify the patient's decision support needs (knowledge, values clarification, support); 3) determine the quality of the decision process; and 4) evaluate the impact of decision support interventions. The DCS comprises 16 items grouped into five sub-scales: certainty, information, clarification of values, support or pressure from others, and the respondent's perception of the quality of the decision process. Each item is measured on a 5-point Likert scale (0 = strongly agree to 4 = strongly disagree). The patient's score is obtained by adding the scores (0-4) for the 16 items, dividing the sum by 16 and then multiplying it by 25

Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.

The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.

All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

This EORTC breast cancer specific questionnaire is intended to supplement the QLQ-C30. The QLQ-BR23 contains 23 items incorporating five multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning. In addition, single items assess sexual enjoyment, hair loss and future perspective. All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale. For all items but sexual functioning and sexual enjoyment, higher scores indicate more severe symptoms.

The EORTC QLQ EDL14 is a self-reporting specific questionnaire developed to assess the quality of life of elderly cancer patients. It addresses generic issues affecting older people with cancer, not covered by the QLQ-C30 or site-specific modules, and can be used in clinical studies that include older patients, regardless of tumour site of health-related quality of life elderly patients with cancer.

The questionnaire contains 14 items incorporating five scales to assess mobility, worries about others, future worries, maintaining purpose, and illness burden. In addition, two single items assess joint stiffness and family support. All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale. High scores indicate poor mobility, good family support, much worry about the future, good maintenance of autonomy and purpose, and high burden of illness.

The Decision Regret Scale is a 5-item Likert-type measure written to assess regret or remorse following a medical decision. Patients respond to the items after reading the prompt: "Please think about the decision you made about [chosen health care decision] after talking to your [doctor, surgeon, nurse, health professional, etc.]." Scores range from of 0 to 100. High scale scores represent higher regret over a health care decision.

Anxiety level Scale (ALS) is 1-item tool developed to measure patient' anxiety. The score range is from 1 to 5. A high scale score represents a higher response level (The score 5 is the level for extremely anxious).

The safety will be evaluated by toxicities assessed using the the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) which is widely accepted in the community of oncology research as the leading rating scale for adverse events.