Helping Ovarian Cancer Patients Cope With Their Illness (HOPE)

Feasibility will be assessed by accrual rates. Feasibility will be examined by conducting frequency and descriptive statistics for enrollment rates. The benchmark for feasibility is >= 50% of screened eligible patients enroll in the study. Feasibility process outcomes will be analyzed to determine whether the intervention is feasible for future dissemination and implementation efforts and recruitment of a full-scale randomized controlled trial (RCT) as well as to determine engagement.

Feasibility will be assessed by rates of intervention completion (all three sessions of HOPE). Feasibility will be examined by conducting frequency and descriptive statistics for intervention workshop completion. The benchmark for feasibility is >= 70% of enrolled patients will complete the intervention (e.g., complete all workshop sessions). Feasibility process outcomes will be analyzed to determine whether the intervention is feasible for future dissemination and implementation efforts and recruitment of a full-scale RCT as well as to determine engagement.

Acceptability will be assessed by the TFA questionnaire, which is an 8-item questionnaire assessing acceptability of healthcare interventions across seven constructions: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness and self-efficacy. The eighth item is a general acceptability item. Items are rated on a 5-point Likert scale (e.g., 1 = strongly dislike, 5 = strongly like) and a mean is computed across all seven constructs and a single outcome is examined for the general item. A cutoff of 70% will be used to assess acceptability. If < 70% agree/rate as acceptable, this indicates modification of the protocol. If >= 70% agree/rate as acceptable, this indicates no modification of the protocol.

Distress will be assessed using two measures. (1) The Patient Health Questionnaire which is an 8-item questionnaire assessing depression on a 4-point Likert scale (0 = not at all, 3 = nearly every day). (2) The Generalized Anxiety Disorder, which is a 7-item self-report anxiety measure asking about how commonly feelings of anxiety are experienced (0 = not at all, 3 = nearly every day), will be used to assess anxiety.

QOL will be assessed using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) scale. The FACT-O is a 39-item, validated scale that assesses the five domains of QOL among ovarian cancer patients: physical, functional, social/family, emotional, and additional concerns related to ovarian cancer. All items are rated on a 5-point Likert scale (0 to 4), with higher scores indicating higher levels of QOL. Will use mixed effects models (linear and logistic). The mixed models will have a patient-level random intercept, fixed effects for time trend parameter(s), treatment and treatment x time interaction. All analyses will be intention-to-treat. Will set α=0.05 and adjust type I error using Holm's stepdown procedure.

Self-efficacy for treatment decision-making will be measured by Decision-Making Participation Self-Efficacy (DEPS) scale. The DEPS scale is a 5-item validated measure that assesses cancer patients' confidence in engaging in difference activities related to decision-making. Patients are asked to indicate how confident they are that they would be able to engage in various decision-making activities (e.g., "Tell your doctor about the option you would prefer"); items are rated on a 5-point Likert scale (1 = not at all confident, 5 = completely confident). Will use mixed effects models (linear and logistic). The mixed models will have a patient-level random intercept, fixed effects for time trend parameter(s), treatment and treatment x time interaction. All analyses will be intention-to-treat. Will set α=0.05 and adjust type I error using Holm's stepdown procedure.

Engagement in ACP will be measured by readiness for ACP using the reliable and valid Advance Care Planning Readiness Scale to assess readiness for end-of-life care conversations. This is an 8-item measure, which is scored on a Likert scale (1 = strongly disagree, 7 = strongly agree), with higher scores indicating increased overall readiness to engage in ACP by discussing and making end-of-life care decisions.

Engagement in ACP will be measured by level of engagement in ACP using the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub-scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken). Higher scores indicate greater engagement in ACP.

Engagement in ACP will be measured by documentation of ACP conversations using an 8-item measure of discussing end-of-life care, living will, health care proxy (HCP), and do-not-resuscitate (DNR) orders with family and doctor. All items are yes/no questions (yes = 1, no = 0). Items are summed to provide an overall measure of ACP conversations from 0 (no conversations) to 8 (all conversations with family and doctors).

This will be assessed by asking patients whether they have completed a Do Not Resuscitate (DNR) order, living will, or identified a health care proxy (HCP). All items are yes/no questions (yes = 1, no =0). Items are summed to provide an overall measure of 0 (no advance directives) to 3 (all advance directives completed).