YES Study - Newly Diagnosed/Metastatic Intervention

One item regarding vaginal dryness on the BCPT will be used and grouped by moderate, quite a bit, extreme responses to define the vaginal dryness rate at 1 year. Based on historical data (from our ongoing Young Women's Breast Cancer Study), the 1-year vaginal dryness rate for the control group is assumed to be 27%. For the Phase II randomized controlled trial component of the study,it will have 85% power to detect a 10% difference in the primary endpoint with 367 patients, and would plan to recruit 408 to account for dropout (last row of the table).

Women will be asked about their race, education, employment and financial status using items selected from the Alliance Patient Questionnaire that is currently being piloted (Alliance A191401), adapted to include an item on employment status that has been tested previously in a breast cancer population and is going to be added to the next version of the Alliance Patient Questionnaire.

Items adapted from the National Health Interview Survey29 and the Cancer Outcomes Research and Surveillance (CanCORS) Caregiver Study30 will be used to assess financial burden and to estimate out of pocket expenses attributed to their breast cancer diagnosis.

Smoking and alcohol use will be evaluated using items selected from the prior cohort study of young women with breast cancer and our prior Smoke Free Study

Physical activity will be assessed using a modified version of the Godin Leisure-Time Exercise Questionnaire (GLTEQ).This self-reported measure is used to estimate weekly frequencies of strenuous, moderate, and light activities. It has been modified to include average duration of activities. Weekly minutes of moderate and vigorous activity (MVPA) will be the main measure of physical activity; however weekly minutes of vigorous activity (MVA) and the average weekly frequency of mild, moderate and strenuous intensity exercise based on the Leisure Score Index (LSI) will also be examined to evaluate change in physical activity behaviors. The Godin measure will be administered at multiple timepoints and will be used to evaluate change in physical activity over time.

The EQ-5D-5L33, 34 is a summary measure of health status for use in evaluating health and healthcare and includes five functional dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) plus a visual analog scale (EQ-VAS) that asks participants to assess how good or bad their health is today on a 0 (worst health imaginable) -100 (best health imaginable) scale. The EQ-5D-5L will be used to generate and evaluate QALYs.

The EQ-5D-5L33, 34 is a summary measure of health status for use in evaluating health and healthcare and includes five functional dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) plus a visual analog scale (EQ-VAS) that asks participants to assess how good or bad their health is today on a 0 (worst health imaginable) -100 (best health imaginable) scale. The EQ-5D-5L will be used to generate and evaluate QALYs. T

The EQ-5D-5L33, 34 is a summary measure of health status for use in evaluating health and healthcare and includes five functional dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) plus a visual analog scale (EQ-VAS) that asks participants to assess how good or bad their health is today on a 0 (worst health imaginable) -100 (best health imaginable) scale. The EQ-5D-5L will be used to generate and evaluate QALYs.

The EQ-5D-5L33, 34 is a summary measure of health status for use in evaluating health and healthcare and includes five functional dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) plus a visual analog scale (EQ-VAS) that asks participants to assess how good or bad their health is today on a 0 (worst health imaginable) -100 (best health imaginable) scale.

The Patient Health Questionnaire (PHQ-9)35, 36 will be used to evaluate for clinically significant depression.

(see management strategy below for the suicidality question in particular). Distress and anxiety will be assessed using select items from the PRO-CTCAE as described below. We will also ask patients to indicate the face that best represents how they feel using a publicly available 5 emoji Likert scale

The Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a patient-centered, standardized self-report measure that enables patients to report symptoms and AEs. The PRO-CTCAE has demonstrated favorable validity, reliability, and responsiveness in a large heterogeneous United States sample of cancer patients undergoing treatment.37 40 PRO-CTCAE items that are salient to young women with breast cancer will be collected. The PRO-CTCAE items use conditional branching for AEs that contain multiple attributes. A modified 19-item version of the Breast Cancer Prevention Trial (BCPT) Symptom Checklist will evaluate common symptoms, including hot flashes, fatigue, sexual problems, and musculoskeletal complaints. The PROMIS 8-item Fatigue Scale will be used to assess fatigue. Sleep quality will be evaluated with the Insomnia Severity Index (ISI) as well as with a modified Self-Assessment of Sleep Survey (SASS).

Measurement of adherence to oral therapy using a 10 item self-report medication adherence measure based on work from Voils et al. among women who report currently prescribed oral hormonal or other oral therapy

AYA concerns will be measured by 14 items from the AYA HOPE Study42 follow-up questionnaire that ask patients to rate their level of concern regarding a range of AYA survivorship-focused issues, including fertility, diet and nutrition, physical activity, weight management, survivorship care, recurrence concerns, and financial concerns, and we have added genetics and body image. 3 items have been added to the AYA Concerns that ask about the desire for additional information about select issues facing young women with breast cancer including about body image/beauty, smoking, and alcohol consumption.

Anxiety and depression will be measured by the 14-item Hospital Anxiety and Depression Scale (HADS). This is a reliable and valid instrument that is well received by patients.