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.
Additional locations may be listed on ClinicalTrials.gov for NCT06666218.
Locations matching your search criteria
United States
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumStatus: Temporarily closed to accrual
Contact: Megan J Shen
Phone: 206-667-4172
PRIMARY OBJECTIVES:
I. To evaluate the levels of feasibility of the adapted version of the HOPE intervention. (Aim 1)
II. To evaluate the levels of acceptability of the adapted version of the HOPE intervention. (Aim 1)
III. To evaluate the levels of satisfaction of the adapted version of the HOPE intervention. (Aim 1)
IV. To examine potential efficacy of the HOPE intervention to reduce patients’ hopelessness/helplessness. (Aim 2)
SECONDARY OBJECTIVES:
I. To evaluate the levels of feasibility of the adapted version of the HOPE intervention. (Aim 2)
II. To evaluate the levels of acceptability of the adapted version of the HOPE intervention. (Aim 2)
III. To examine potential efficacy of the HOPE intervention to improve quality of life (QOL). (Aim 2)
IV. To examine potential efficacy of the HOPE intervention to improve self-efficacy for treatment decision-making. (Aim 2)
V. To examine potential efficacy of the HOPE intervention to improve engagement in advance care planning (ACP). (Aim 2)
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 baseline and follow up assessments 5, 8, and 12 weeks after the randomization event.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorMegan J Shen
