Novel e-Health Intervention for Fear of Progression in Women With Gynecologic Cancer: A Pilot Study
Overview
- Phase
- N/A
- Intervention
- Discussion
- Conditions
- Malignant Female Reproductive System Neoplasm
- Sponsor
- City of Hope Medical Center
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Feasibility of recruitment (enrollment rate)
- Status
- Active, Not Recruiting
- Last Updated
- 3 months ago
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.
Investigators
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)
Arms & Interventions
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.
Intervention: Discussion
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.
Intervention: Informational Intervention
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.
Intervention: Media Intervention
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.
Intervention: Questionnaire Administration
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.
Intervention: Telephone-Based Intervention
Outcomes
Primary Outcomes
Feasibility of recruitment (enrollment rate)
Time Frame: 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)