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

Not Applicable

Active, not recruiting

• Conditions: Malignant Female Reproductive System Neoplasm; Stage III Ovarian Cancer AJCC v8; Stage IV Vaginal Cancer AJCC v8; Stage III Uterine Corpus Cancer AJCC v8; Stage IV Uterine Corpus Cancer AJCC v8; Stage IV Vulvar Cancer AJCC v8; Stage III Cervical Cancer AJCC v8; Stage III Vaginal Cancer AJCC v8; Stage III Vulvar Cancer AJCC v8; Stage IV Cervical Cancer AJCC v8
• Interventions: Procedure: Discussion; Other: Informational Intervention; Other: Media Intervention; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention

• Registration Number: NCT05786456
• Lead Sponsor: City of Hope Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2023-03-10
• Study First Submitted QC: 2023-03-24
• Study First Posted: 2023-03-27
• Study Start: 2024-07-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-06-20
• Study Completion: 2025-06-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 23

Inclusion Criteria

• Women with stage III or IV GYN cancer (ovarian, endometrial, cervical, vulvar/vaginal);at least 3 months from initial diagnosis
• Age: >= 18 years
• Score >= 34 on the Fear of Progression Short-Form, indicating dysfunctional levels
• Ability to read and understand English
• Patients in remission or with progressive disease are eligible

Exclusion Criteria

• Enrolled in hospice
• Severe depression as assessed by Patient Health Questionnaire (PHQ-9)
• Non-English speaking
• Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Care (DBD)	Informational Intervention	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.
Supportive Care (DBD)	Discussion	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.
Supportive Care (DBD)	Media Intervention	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.
Supportive Care (DBD)	Questionnaire Administration	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.
Supportive Care (DBD)	Telephone-Based Intervention	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of recruitment (enrollment rate)	Up to 6 weeks	Defined by attendance, attrition, and skills practice adherence. Website acceptability is based on the System Usability Scale, log-in activity, activity completion rate, and most frequently visited site content.

Secondary Outcome Measures

Name	Time	Method
Fear of progression (FOP)	Up to 12 weeks	FOP will be assessed using FOP Questionnaire-Short Form (SF) at baseline (T1), weeks (T2), and 12 weeks (T3). FOP-Q-SF consists of 12 items scored on a 5-point Likert scale (1=never to 5=very often); scores range from 12-60 with higher levels indicating greater FOP. Researchers have used a cut-off of 34 and above to indicate dysfunctional FOP.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States