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

N/AActive Not RecruitingNCT05786456

City of Hope Medical Center23 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Interventions

DiscussionPROCEDURE

Participate in group and web-based self-study sessions

Informational InterventionOTHER

Receive handouts

Media InterventionOTHER

View videos

Questionnaire AdministrationOTHER

Ancillary studies

Telephone-Based InterventionBEHAVIORAL

Participate in check-in calls

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: Up to 6 weeks

Secondary Outcomes

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.

Time frame: Up to 12 weeks