Helping Ovarian Cancer Patients Cope With Their Illness (HOPE)

NCT ID: NCT06666218

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-24
• Study Completion Date: 2027-01-31

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.

Conditions

Recurrent Ovarian Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Aim 1 (HOPE intervention workshop, survey, interview)

Patients complete the HOPE intervention workshop virtually or in person. The workshop consists of three weekly sessions, each lasting 60 to 90 minutes, along with a survey and an interview for HOPE Intervention refinement during follow up.

Group Type: EXPERIMENTAL

Behavioral Intervention

Intervention Type: BEHAVIORAL

Complete the HOPE intervention workshop

Electronic Health Record Review

Intervention Type: OTHER

Ancillary studies

Interview

Intervention Type: OTHER

Complete an interview

Survey Administration

Intervention Type: OTHER

Complete a survey

Aim 2, Group I (HOPE intervention workshop)

Patients complete the HOPE intervention workshop either virtually or in person, with three weekly sessions, each lasting 60 to 90 minutes.

Group Type: EXPERIMENTAL

Behavioral Intervention

Intervention Type: BEHAVIORAL

Complete the HOPE intervention workshop

Electronic Health Record Review

Intervention Type: OTHER

Ancillary studies

Survey Administration

Intervention Type: OTHER

Ancillary studies

Aim 2, Group II (usual care)

Patients receive usual care on study.

Group Type: ACTIVE_COMPARATOR

Electronic Health Record Review

Intervention Type: OTHER

Ancillary studies

Survey Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Behavioral Intervention

Complete the HOPE intervention workshop

Intervention Type: BEHAVIORAL

Electronic Health Record Review

Ancillary studies

Intervention Type: OTHER

Interview

Complete an interview

Intervention Type: OTHER

Survey Administration

Complete a survey

Intervention Type: OTHER

Survey Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Behavior Conditioning Therapy; Behavior Modification; Behavior or Lifestyle Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Megan J. Shen, PhD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Countries

United States

Other Identifiers

NCI-2024-08640

Identifier Type: REGISTRY

Identifier Source: secondary_id

20682

Identifier Type: OTHER

Identifier Source: secondary_id

RG1124787

Identifier Type: -

Identifier Source: org_study_id