Helping Ovarian Cancer Patients Cope With Their Illness (HOPE)

NCT06666218 | Suspended

• 3 other identifiers: RG1124787NCI-2024-0864020682
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Ovarian Carcinoma

Outcome Measures

Primary Outcomes (6)

• Accrual rates (Aim 1)

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

  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.

  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.

  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.

  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.

  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).

  Baseline to 12 weeks post-randomization

Secondary Outcomes (10)

• Accrual rates (Aim 2)

  At the time of enrollment

• Rates of intervention completion (Aim 2)

  Up to 35 days

• Acceptability of the HOPE intervention (Aim 2)

  5-weeks post-randomization

• Change in distress (Aim 2)

  Baseline to 5 weeks post-randomization

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

  Baseline to 5 weeks post-randomization

Study Arms (3)

Aim 1 (HOPE intervention workshop, survey, interview)

EXPERIMENTAL

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.

Behavioral: Behavioral Intervention; Other: Electronic Health Record Review; Other: Interview; Other: Survey Administration

Aim 2, Group I (HOPE intervention workshop)

EXPERIMENTAL

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

Behavioral: Behavioral Intervention; Other: Electronic Health Record Review; Other: Survey Administration

Aim 2, Group II (usual care)

ACTIVE COMPARATOR

Patients receive usual care on study.

Other: Electronic Health Record Review; Other: Survey Administration

Interventions

Behavioral Intervention BEHAVIORAL

Complete the HOPE intervention workshop

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Lifestyle Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Aim 1 (HOPE intervention workshop, survey, interview); Aim 2, Group I (HOPE intervention workshop)

Electronic Health Record Review OTHER

Ancillary studies

Aim 1 (HOPE intervention workshop, survey, interview); Aim 2, Group I (HOPE intervention workshop); Aim 2, Group II (usual care)

Interview OTHER

Complete an interview

Aim 1 (HOPE intervention workshop, survey, interview)

Survey Administration OTHER

Complete a survey

Aim 1 (HOPE intervention workshop, survey, interview)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Behavior Therapy; Interviews as Topic

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Megan J. Shen, PhD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: February 24, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)