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
NCT ID: NCT05786456
Last Updated: 2026-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
23 participants
INTERVENTIONAL
2024-07-19
2026-12-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Discussion
Participate in group and web-based self-study sessions
Informational Intervention
Receive handouts
Media Intervention
View videos
Questionnaire Administration
Ancillary studies
Telephone-Based Intervention
Participate in check-in calls
Interventions
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Discussion
Participate in group and web-based self-study sessions
Informational Intervention
Receive handouts
Media Intervention
View videos
Questionnaire Administration
Ancillary studies
Telephone-Based Intervention
Participate in check-in calls
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Anne Reb
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Other Identifiers
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NCI-2023-00309
Identifier Type: REGISTRY
Identifier Source: secondary_id
22683
Identifier Type: OTHER
Identifier Source: secondary_id
22683
Identifier Type: -
Identifier Source: org_study_id
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