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Active, not recruitingNCT05786456Updated Jan 28, 2026

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

An interventional study of Discussion and Informational Intervention in Malignant Female Reproductive System Neoplasm, Stage III Cervical Cancer AJCC v8 and Stage III Ovarian Cancer AJCC v8, sponsored by City of Hope Medical Center. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.

Sponsored by City of Hope Medical Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
  • 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
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 23 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    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.

    Procedure: Discussion · Other: Informational Intervention · Other: Media Intervention · Other: Questionnaire Administration · Behavioral: Telephone-Based Intervention

Interventions

  • ProcedureDiscussion

    Participate in group and web-based self-study sessions

    Also known as: Discuss

  • OtherInformational Intervention

    Receive handouts

  • OtherMedia Intervention

    View videos

  • OtherQuestionnaire Administration

    Ancillary studies

  • BehavioralTelephone-Based Intervention

    Participate in check-in calls

06

What researchers measure

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.

    Time frame: Up to 6 weeks

Secondary outcomes

  1. 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

07

Study locations

1 site
  • City of Hope Medical Center
    Duarte, California 91010, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05786456
Lead sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Mar 27, 2023
Start date
Jul 19, 2024
Primary completion
Dec 15, 2026 (estimated)
Completion
Dec 15, 2026 (estimated)
Last update
Jan 28, 2026

Study contacts

Anne Reb
principal investigator · City of Hope Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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