Clinical trial NCT06666218: Helping Ovarian Cancer Patients Cope With Their Illness (HOPE)
Official title: Helping Ovarian Cancer Patients Cope With Their Disease (HOPE) - Phase 2
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Recurrent Ovarian Carcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 18 years of age or older
* English speaking
* Able to provide informed consent
* Current diagnosis of recurrent epithelial ovarian cancer (regardless of the amount of time since the diagnosis, given the poor prognosis of this illness with a median survival time of less than 2 years)

Exclusion Criteria:

* Patients with non-invasive gynecologic disease (i.e., dysplasia)

Primary outcomes:
measure: Accrual rates (Aim 1)
timeFrame: At the time of enrollment
measure: Fidelity rates (Aim 1)
timeFrame: Up to 28 days
measure: Rates of intervention completion (Aim 1)
timeFrame: Up to 28 days
measure: Acceptability of the HOPE intervention (Aim 1)
timeFrame: Up to 28 days
measure: Overall satisfaction (Aim 1)
timeFrame: Up to 28 days
measure: Change in hopelessness/helplessness (Aim 2)
timeFrame: Baseline to 12 weeks post-randomization
Secondary outcomes:
measure: Accrual rates (Aim 2)
timeFrame: At the time of enrollment
measure: Rates of intervention completion (Aim 2)
timeFrame: Up to 35 days
measure: Acceptability of the HOPE intervention (Aim 2)
timeFrame: 5-weeks post-randomization
measure: Change in distress (Aim 2)
timeFrame: Baseline to 5 weeks post-randomization
measure: Change in quality of life (QOL) (Aim 2)
timeFrame: Baseline to 5 weeks post-randomization
measure: Change in self-efficacy for treatment decision-making (Aim 2)
timeFrame: Baseline to 5 weeks post-randomization
measure: Change in readiness for advance care planning (ACP) (Aim 2)
timeFrame: Baseline to 5 weeks post-randomization
measure: Change in level of engagement in advance care planning (ACP) (Aim 2)
timeFrame: Baseline to 5 weeks post-randomization
measure: Change in documentation of advance care planning (ACP) conversations (Aim 2)
timeFrame: Baseline to 5 weeks post-randomization
measure: Change in completion of advance care directives (Aim 2)
timeFrame: Baseline to 5 weeks post-randomization
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Megan J. Shen, PhD
role: PRINCIPAL_INVESTIGATOR
References: