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

Study Overview
=================
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.

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

Conditions
-----------------
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, 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

Intervention / Treatment
-----------------
* Procedure: Discussion
* Other: Informational Intervention
* Other: Media Intervention
* Other: Questionnaire Administration
* Behavioral: Telephone-Based Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care (DBD)<br>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<br>* Participate in group and web-based self-study sessions<br>* Other names: Discuss;Other: Informational Intervention<br>* Receive handouts<br>Other: Media Intervention<br>* View videos<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Behavioral: Telephone-Based Intervention<br>* Participate in check-in calls<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of recruitment (enrollment rate) | 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. | Up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of progression (FOP) | 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. | Up to 12 weeks |