Improving Outcomes in Early Menopause After Cancer

Feasibility will be assessed by examining trial enrollment over the course of 10 months. The trial will be considered feasible if the study enrolls N=60 participants in 10 months, or 100% of the enrollment goal within 10 months. Thus, enrollment will be assessed by measuring the percentage of the enrollment goal at the end of 10 months.

Feasibility will be assessed by examining attrition. Attrition will be measured by the percentage of participants who drop out of the study. The intervention will be considered feasible if >80% of participants complete 6 sessions.

Feasibility will be assessed by examining participants' use of intervention strategies using a novel measure adapted for this study. Participants will be asked how often they have used the strategies presented in the intervention, with responses ranging from 0 ("Not at all") to 5 ("Every day"). Participants will also be asked about how often they have used each individual strategy or skill with responses ranging from 0 ("Not at all") to 4 ("6 or more days/week"). The intervention will be considered feasible if ≥75% of participants report use of intervention skills.

Acceptability will be assessed using the Treatment Acceptability Questionnaire (TAQ). The Treatment Acceptability Questionnaire (TAQ) is a six-item scale assessing whether participants view an intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 "very unacceptable" to 7 "very acceptable"). The intervention will be considered acceptable if >80% of participants rate the intervention as >5 out of 7 on the TAQ.

Acceptability will be assessed using the Client Satisfaction Questionnaire (CSQ). The CSQ is an 8-item self-report scale to assess participant satisfaction; each item on this scale is scored from 1 to 4, with higher scores indicating higher satisfaction. The intervention will be considered acceptable if >80% of participants rate the intervention as >3 out of 4 on the CSQ.

Knowledge will be assessed using an item pool developed for the study. Each participant will complete 10 items based on the risk-based education they received. Knowledge will be calculated as the percent of correct items (from 0% to 100%).

Symptom severity and interference will be measured via the Menopause Specific Quality of Life Questionnaire (MENQOL). The 32-item MENQOL assesses the degree of symptom interference in the past week related to four domains: physical symptoms, vasomotor symptoms, psychosocial symptoms, and sexual symptoms. For each symptom that a participant endorses, they will be asked to rate how much they have been bothered by the symptom on a 7-point scale from 0 ("Not at all bothered") to 6 ("Extremely bothered").

Symptom severity and interference will be measured via the PROMIS® Anxiety 8-item Short Form, an 8-item measure assessing symptoms of anxiety in the last week. Participants are asked to respond to items (e.g., "I felt nervous," "I felt tense") using a five-point scale ranging from 1 "never" to 5 "always".

Symptom severity and interference will be measured via the PROMIS® Depression 8-item Short Form, an 8-item measure assessing symptoms of depression in the last week. Participants are asked to respond to items (e.g., "I felt sad," "I felt helpless") using a five-point scale ranging from 1 "never" to 5 "always."

Symptom severity and interference will be measured via the Illness Intrusiveness Rating Scale (IIRS). The IIRS assesses the extent to which an illness and/ or its treatments interfere with 13 quality of life domains (e.g., health, diet, work, sex life, active recreation). Items are rated on a 7-point scale from 1 "not very much" to 7 "very much."

Decisional conflict related to menopause management will be assessed using the Decisional Conflict Scale (DCS). The DCS is a 16-item measure assessing decisional conflict. The response ranges are on a 5-point Likert scale ranging from strongly agree to strongly disagree. The minimum score is a 0 and the maximum score is 100, with higher scores indicating more decisional conflict.

Self-efficacy will be assessed using the Decision Self-Efficacy Scale, an 11-item measure which assesses self-confidence or belief in one's abilities in decision making, including shared decision making. Responses to each item range from 0 (not at all confident) to 4 (very confident).

Self-efficacy for managing symptoms will be assessed using an 8-item measure in which participants are asked to rate how confident they are that they can manage common symptoms related to menopause. Participants will be asked to rate their confidence in managing symptoms on a 10-point scale from 1 ("Not at all confident") to 10 ("Very confident").

Patient activation will be assessed using the Patient Activation Measure (PAM). The PAM is a 13-item measure used to assess survivors' knowledge, skills, and confidence that are central to managing their health and health care. Patients are asked to rate their agreement with statements about their health and health care on a 4 point scale from "strongly disagree" to "strongly agree." From these response a total PAM score is calculated on a scale of 0-100, with higher scores indicating higher levels of activation.