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

NCT05786456 — Not applicable, Active not recruiting, 23 participants, City of Hope Medical Center

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT05786456
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, supportive care
Enrollment	23 (Actual)
Sponsor	City of Hope Medical Center (Other); collaborators: National Cancer Institute (NCI)
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	Discussion, Informational Intervention, Media Intervention, Questionnaire Administration, Telephone-Based Intervention (Procedure, other, behavioral)
Dates	start 2024-07-19, primary completion 2026-12-15 (estimated), completion 2026-12-15 (estimated), first posted 2023-03-27, last updated 2026-01-28
Locations	1 site in United States

-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.

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
Supportive Care (DBD)	Experimental	Procedure: Discussion; Other: Informational Intervention; Other: Media Intervention; Other: Questionnaire Administration; Behavioral: 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.

Discussion (Procedure), also known as Discuss: Participate in group and web-based self-study sessions
Informational Intervention (Other): Receive handouts
Media Intervention (Other): View videos
Questionnaire Administration (Other): Ancillary studies
Telephone-Based Intervention (Behavioral): Participate in check-in calls

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: Female, ages: 18 Years to any

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)

+Locations (1)

Facility	City	Country	Status
City of Hope Medical Center	Duarte, California	United States

+Investigators

Anne Reb, Principal investigator, City of Hope Medical Center

+Funding

NIH grants: P30CA033572