Helping Ovarian Cancer Patients Cope With Their Illness (HOPE)

Fred Hutchinson Cancer Center60 enrolled

Overview

This clinical trial compares the effect of the Helping Ovarian Cancer Patients Cope with Their Disease (HOPE) intervention to usual care for the reduction of hopelessness and helplessness in patients with ovarian cancer that has come back after a period of improvement (recurrent). Patients with recurrent ovarian cancer are at high risk for increased death and poor mental health outcomes, including depression and anxiety. Ovarian cancer is the deadliest of all gynecologic cancers, with a survival rate at five years of only 50%. Most patients are diagnosed with advanced disease and have a high chance of recurrent disease that is incurable, even if upfront treatments are effective. Ovarian cancer's advanced diagnosis, high likelihood of recurrence and death, and rigorous treatment including surgery and other cancer therapies create high levels of distress and reduced quality of life (QOL). Patients with recurrent ovarian cancer report high rates of depression and anxiety and poor QOL. Due to the major distress, reduced QOL, and likelihood of death among this population, improving this patient population's QOL is a priority. Using the HOPE intervention may be effective in reducing hopelessness and helplessness in recurrent ovarian cancer patients.

OUTLINE: AIM 1: Patients complete the HOPE intervention workshop virtually or in-person. The workshop consists of 3 sessions, each held once per week and lasting 60 to 90 minutes as well as complete a survey and an interview for HOPE intervention refinement during follow up. AIM 2: Patients are randomized to 1 of 2 groups. GROUP I: Patients complete the HOPE intervention workshop virtually or in-person, with 3 sessions held once per week, each lasting 60 to 90 minutes. GROUP II: Patients receive usual care on study. Patients in both groups complete baselines and follow up assessments 5, 8, and 12 weeks after the randomization event.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Outcomes

Primary Outcomes

Accrual rates (Aim 1)

Feasibility will be assessed by accrual rates. Feasibility cutoffs will include \>= 50% of eligible patients will enroll in the study.

Time frame: At the time of enrollment

Fidelity rates (Aim 1)

Feasibility will be assessed by fidelity rates. Feasibility cutoffs will include \>= 75% of HOPE workshop sessions delivered with fidelity.

Time frame: Up to 28 days

Rates of intervention completion (Aim 1)

Feasibility will be assessed by rates of intervention completion (all three sessions of Helping Ovarian Cancer Patients Cope with Their Disease \[HOPE\]). Feasibility cutoffs will include 70% of enrolled patients will complete all workshop sessions.

Time frame: Up to 28 days

Acceptability of the HOPE intervention (Aim 1)

Acceptability will be assessed by the Theoretical Framework of Acceptability (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. Scores on the TFA questionnaire will be calculated using the total mean score of seven TFA items. A single-item score will be used for the remaining eighth item, which is a general item assessing acceptability. In this study, will use a cutoff of \>= 70% agreeing (or rating as confident, liking, acceptable) as being acceptable for use.

Time frame: Up to 28 days

Overall satisfaction (Aim 1)

Satisfaction will be assessed by using three items assessing overall satisfaction (How satisfied are you? How likely are you to recommend to someone? How likely would you participate in this workshop knowing what it is like now?). A cutoff score of \>= 7 (out of 10) will be used as a cutoff for each satisfaction item.

Time frame: Up to 28 days

Change in hopelessness/helplessness (Aim 2)

Hopelessness/helplessness will be measured by the helplessness/hopelessness subscale of the Mental Adjustment to Cancer (MAC) scale. The MAC scale is a widely used, 40-item scale that assesses patients' psychological responses to cancer. Items are given as statements (e.g., "I feel that life is hopeless") and patients report their agreement using a 4-point Likert-scale (1 = definitely does not apply to me, 2 = does not apply to me, 3 = applies to me, 4 = definitely applies to me).

Time frame: Baseline to 12 weeks post-randomization

Secondary Outcomes

Accrual rates (Aim 2)

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.

Time frame: At the time of enrollment

Rates of intervention completion (Aim 2)

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.

Time frame: Up to 35 days

Acceptability of the HOPE intervention (Aim 2)

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.

Time frame: 5-weeks post-randomization

Change in distress (Aim 2)

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.

Change in quality of life (QOL) (Aim 2)

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.