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

Malignant Female Reproductive System Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05786456
• Other study ID #: 22683
• Secondary ID: NCI-2023-0030922
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: December 20, 2024

Study information

• Verified date: April 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 20, 2024
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Genital Neoplasms, Female
• Malignant Female Reproductive System Neoplasm
• Ovarian Neoplasms
• 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
• Uterine Cervical Neoplasms
• Vaginal Neoplasms
• Vulvar Neoplasms

Intervention

Procedure:
• Discussion
Participate in group and web-based self-study sessions

Other:
• Informational Intervention
Receive handouts
• Media Intervention
View videos
• Questionnaire Administration
Ancillary studies

Behavioral:
• Telephone-Based Intervention
Participate in check-in calls

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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