NCT05786456

e-Health Intervention (Day-by-Day) for the Management of Fear of Progression in Women With Stage III or IV Gynecologic Cancer: A Pilot Study

Novel e-Health Intervention for Fear of Progression in Women With Gynecologic Cancer: A Pilot Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies how well an electronic (e)-health intervention (day-by-day) woks in managing fears or worries about cancer growing, spreading, or getting worse (progression) in patients with stage III or IV gynecologic cancer. Fear and worries about cancer progression or recurrence (coming back) are common concerns. This may contribute to concerns related to illness, worries, and uncertainty about the future. Day by Day is adapted from a program called "Conquer Fear" which was shown to benefit patients with early-stage cancer. Day-by-day intervention may help refocus patient thoughts and help patients learn skills to manage anxiety and fears.

Detailed description

PRIMARY OBJECTIVES: I. Will adapt the intervention into a hybrid format including two group and three web based self-study sessions. (Phase 1) II. To determine the feasibility and acceptability of a new hybrid e-health intervention to manage fear of progression (FOP) in patients with stage III or IV gynecologic (GYN) cancer. (Phase 2) SECONDARY OBJECTIVE: I. To explore the preliminary efficacy of day-by-day (DBD) on reducing FOP (primary outcome) and improving secondary outcomes of distress, anxiety, depression, metacognitions, and mindfulness. (Exploratory) OUTLINE: PHASE I (DEVELOPMENT): Patients complete surveys and participate in focus groups. PHASE II (DBD): Patients receive DBD intervention consisting of group and web-based self-study sessions and check-in calls on study. Patients also watch videos and receive handouts to reinforce the group sessions.

Conditions

• Malignant Female Reproductive System Neoplasm
• Stage III Cervical Cancer AJCC v8
• Stage III Ovarian Cancer AJCC v8
• Stage III Uterine Corpus Cancer AJCC v8
• Stage III Vaginal Cancer AJCC v8
• Stage III Vulvar Cancer AJCC v8
• Stage IV Cervical Cancer AJCC v8
• Stage IV Ovarian Cancer AJCC v8
• Stage IV Uterine Corpus Cancer AJCC v8
• Stage IV Vaginal Cancer AJCC v8
• Stage IV Vulvar Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Discussion	Participate in group and web-based self-study sessions
OTHER	Informational Intervention	Receive handouts
OTHER	Media Intervention	View videos
OTHER	Questionnaire Administration	Ancillary studies
BEHAVIORAL	Telephone-Based Intervention	Participate in check-in calls

Timeline

• Start date: 2024-07-19
• Primary completion: 2026-12-15
• Completion: 2026-12-15
• First posted: 2023-03-27
• Last updated: 2026-01-28

Locations

1 site across 1 country: United States