Helping Ovarian Cancer Patients Cope With Their Illness (HOPE)

Fred Hutchinson Cancer Center (FHCC)

Status

Suspended

Conditions

Recurrent Ovarian Carcinoma

Treatments

Behavioral: Behavioral Intervention

Other: Interview

Other: Electronic Health Record Review

Other: Survey Administration

Study type

Interventional

Funder types

Other

Identifiers

NCT06666218

RG1124787

NCI-2024-08640 (Registry Identifier)

20682

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 3 patient groups

Aim 1 (HOPE intervention workshop, survey, interview)

Experimental group

Description:

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.

Treatment:

Other: Survey Administration

Other: Electronic Health Record Review

Other: Interview

Behavioral: Behavioral Intervention

Aim 2, Group I (HOPE intervention workshop)

Experimental group

Description:

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

Treatment:

Other: Survey Administration

Other: Electronic Health Record Review