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Trial Title:
Helping Ovarian Cancer Patients Cope With Their Illness (HOPE)
NCT ID:
NCT06666218
Condition:
Recurrent Ovarian Carcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Behavioral Intervention
Description:
Complete the HOPE intervention workshop
Arm group label:
Aim 1 (HOPE intervention workshop, survey, interview)
Arm group label:
Aim 2, Group I (HOPE intervention workshop)
Other name:
Behavior Conditioning Therapy
Other name:
Behavior Modification
Other name:
Behavior or Lifestyle Modifications
Other name:
Behavior Therapy
Other name:
Behavioral Interventions
Other name:
Behavioral Modification
Other name:
Behavioral Therapy
Other name:
Behavioral Treatment
Other name:
Behavioral Treatments
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Aim 1 (HOPE intervention workshop, survey, interview)
Arm group label:
Aim 2, Group I (HOPE intervention workshop)
Arm group label:
Aim 2, Group II (usual care)
Intervention type:
Other
Intervention name:
Interview
Description:
Complete an interview
Arm group label:
Aim 1 (HOPE intervention workshop, survey, interview)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Complete a survey
Arm group label:
Aim 1 (HOPE intervention workshop, survey, interview)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Aim 2, Group I (HOPE intervention workshop)
Arm group label:
Aim 2, Group II (usual care)
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.
Criteria for 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)
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fred Hutch/University of Washington Cancer Consortium
Address:
City:
Seattle
Zip:
98109
Country:
United States
Contact:
Last name:
Megan J. Shen, PhD
Phone:
206-667-4172
Email:
mshen2@fredhutch.org
Investigator:
Last name:
Megan J. Shen, PhD
Email:
Principal Investigator
Start date:
February 1, 2025
Completion date:
January 31, 2027
Lead sponsor:
Agency:
Fred Hutchinson Cancer Center
Agency class:
Other
Source:
Fred Hutchinson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06666218
