Study Stopped
slow accrual
Virtual Mental Health Intervention to Address Fear of Progression for Women With High Risk or Stage III-IV Gynecologic or Breast Cancer
An E-Health Intervention for Fear of Progression in Women With Gynecologic or Breast Cancer
4 other identifiers
interventional
N/A
1 country
12
Brief Summary
This clinical trial tests feasibility, acceptability and how well a virtual mental health intervention, compared to enhanced usual care consisting of an educational intervention, works to address fear of progression for women with high risk or stage III-IV gynecologic or breast cancer. Worrying about cancer coming back or progression is natural for cancer patients. Many cancer patients face stress and uncertainty as they live longer and attend regular check-ups. A supportive program can help to develop skills to feel calmer and more resilient during uncertain times and better manage feelings of fear. The virtual mental health intervention may be a feasible, acceptable and effective may to address fear of progression for women with high risk or stage III-IV gynecologic or breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2026
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2025
CompletedFirst Posted
Study publicly available on registry
November 10, 2025
CompletedStudy Start
First participant enrolled
July 16, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2026
Study Completion
Last participant's last visit for all outcomes
July 16, 2026
February 4, 2026
February 1, 2026
Same day
October 16, 2025
February 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Fear of cancer progression (FOP-SF)
FOP-SF consists of 12 items pertaining to 4 subscales: affective reactions; partnership/family; occupation; loss of autonomy. Scores range from 12-60; higher levels indicate greater FOP; a cut-off of 34 and above indicates dysfunctional FOP levels. The FOP-SF has been validated in a large sample of breast and mixed cancer patients (a=.87) patients who completed a rehabilitation program (a=.90). The correlation between the long and short form of the questionnaires is r=0.92. Validity has been demonstrated by correlation with HADS anxiety (r=.65 to .71), GAD anxiety (r=.57) and depression (r=.49). In a descriptive FOP study in 135 English-speaking cancer survivors, the FOP-SF showed high internal consistency (a=0.88) and was correlated with similar constructs: Intrusions (r=.72), metacognitive beliefs (r=0.62); death anxiety (r=0.67) (Curran et al., 2020).
Baseline, 6 weeks, up to 12 weeks
Secondary Outcomes (4)
Cancer-related distress - Impact of Event Scale-R (IES-R)
Baseline, 6 weeks, Up to 12 weeks
Anxiety - PROMIS - Anxiety 8-a
Baseline, 6 weeks, Up to 12 weeks
Metacognitive Beliefs - Metacognitions questionnaire (MCQ-18)
Baseline, 6 weeks, Up to 12 weeks
Mindfulness - Five Facet Mindfulness Questionnaire (FFMQ-15)
Baseline, 6 weeks, Up to 12 weeks
Study Arms (2)
Arm I (Fear of progression intervention)
EXPERIMENTALPatients receive access to the Day by Day platform that includes patient partner videos, testimonials, handouts and a community forum. Patients may optionally utilize these resources for 6 weeks. Patients attend online group sessions, over 60 minutes, for every other week for 3 sessions and complete online educational sessions on values clarification, managing worry and unhelpful thoughts, and skills practices to promote healthy coping on alternate weeks for 3 sessions. Patients complete a check in call, for 15-20 minutes, at week 3-4. Patients are asked to practice the skills including attention training, mindfulness, worry postponement, guided imagery and other practices from the intervention for 10-12 minutes, at least 6 days per week for and track their practice on the Day to Day platform for 6 weeks. Patients may be loaned a tablet if needed for 6 weeks.
Arm II (Educational intervention)
ACTIVE COMPARATORPatients receive access to the Empower Hope platform. Patients attend online group sessions, over 60 minutes, for every other week for 3 sessions and complete online educational sessions on clinical trial participation, identifying reliable online information, healthy living on nutrition and activity/exercise and coping with fatigue on alternate weeks for 3 sessions. Patients complete a check in call, for 15-20 minutes, at week 3-4. Patients may be loaned a tablet if needed for 6 weeks.
Interventions
Attend online group sessions
Receive access to patient partner videos, testimonials, handouts and a community forum
Receive access to Day to Day platform
Ancillary studies
Ancillary studies
Receive a tablet
Eligibility Criteria
You may qualify if:
- Women with stage III or IV GYN (ovarian, endometrial, cervical, vulvar/vaginal) or breast cancer who are at least 2 months from initial diagnosis
- Women with high-risk disease e.g., carcinosarcoma; ovarian cancer stage II or grade III histology; endometrioid endometrial cancer stage II or III; grade III with LVI or deep invasion; serous, clear cell or undifferentiated histologies; triple negative breast cancer
- Score ≥ 34 on the Fear of Progression Short-Form, indicating dysfunctional levels
- Age 18 or older; able to read and understand English
- Patients in remission or with progressive disease
You may not qualify if:
- Enrolled in hospice
- Major 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- City of Hope Medical Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (12)
City of Hope at Arcadia
Arcadia, California, 91007, United States
City of Hope Medical Center
Duarte, California, 91010, United States
City of Hope at Irvine Lennar
Irvine, California, 92618, United States
City of Hope Antelope Valley
Lancaster, California, 93534, United States
City of Hope at Long Beach Worsham
Long Beach, California, 90808, United States
City of Hope at Long Beach Elm
Long Beach, California, 90813, United States
City of Hope Mission Hills
Mission Hills, California, 91345, United States
City of Hope - Santa Clarita
Santa Clarita, California, 91355, United States
City of Hope at Simi Valley
Simi Valley, California, 93065, United States
City of Hope at Thousand Oaks
Thousand Oaks, California, 91361, United States
City of Hope South Bay
Torrance, California, 90503, United States
City of Hope Upland
Upland, California, 91786, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Reb
City of Hope Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- Following completion of baseline questionnaires and the intake call, the clinical research assistant will be informed of the group assignment. The study team is blinded to assignment until this point. The study participants will be blinded to group assignment (single-blind).
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2025
First Posted
November 10, 2025
Study Start (Estimated)
July 16, 2026
Primary Completion (Estimated)
July 16, 2026
Study Completion (Estimated)
July 16, 2026
Last Updated
February 4, 2026
Record last verified: 2026-02