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

Sponsor

City of Hope Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05786456

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

19.1

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Procedure: Discussion Other: Informational Intervention Other: Media Intervention Other: Questionnaire Administration Behavioral: Telephone-Based Intervention	N/A

Detailed Description

PRIMARY OBJECTIVES:

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:

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 Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jun 15, 2023

Anticipated Primary Completion Date :

Jan 15, 2025

Anticipated Study Completion Date :

Jan 15, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Supportive Care (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.	Procedure: Discussion Participate in group and web-based self-study sessions Other Names: Discuss Other: Informational Intervention Receive handouts Other: Media Intervention View videos Other: Questionnaire Administration Ancillary studies Behavioral: Telephone-Based Intervention Participate in check-in calls

Arm

Intervention/Treatment

Experimental: Supportive Care (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.

Procedure: Discussion

Participate in group and web-based self-study sessions

Other Names:

Discuss

Other: Informational Intervention

Receive handouts

Other: Media Intervention

View videos

Other: Questionnaire Administration

Ancillary studies

Behavioral: Telephone-Based Intervention

Participate in check-in calls

Outcome Measures

Primary Outcome Measures

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

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 Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)