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

NCT05786456 | Active Not Recruiting DMC

• 3 other identifiers: 22683NCI-2023-00309P30CA033572
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage III Ovarian Cancer AJCC v8; Malignant Female Reproductive System Neoplasm; Stage III Cervical 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Fear of progression (FOP)

  Up to 12 weeks

Study Arms (1)

Supportive Care (DBD)

EXPERIMENTAL

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; Other: Informational Intervention; Other: Media Intervention; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention

Interventions

Discussion PROCEDURE

Participate in group and web-based self-study sessions

Also known as: Discuss

Supportive Care (DBD)

Informational Intervention OTHER

Receive handouts

Supportive Care (DBD)

Media Intervention OTHER

View videos

Supportive Care (DBD)

Questionnaire Administration OTHER

Ancillary studies

Supportive Care (DBD)

Telephone-Based Intervention BEHAVIORAL

Participate in check-in calls

Supportive Care (DBD)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Ovarian Neoplasms; Vaginal Neoplasms; Vulvar Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Vaginal Diseases; Vulvar Diseases

Study Officials

• Anne Reb

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 27, 2023
• Study Start: July 19, 2024
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

US (1)