Virtual Mental Health Intervention to Address Fear of Progression for Women With High Risk or Stage III-IV Gynecologic or Breast Cancer

February 2, 2026 updated by: City of Hope Medical Center

An E-Health Intervention for Fear of Progression in Women With Gynecologic or Breast Cancer

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To determine the feasibility and acceptability of a blended e-health intervention to manage fear of progression (FOP) in patients with stage III or IV gynecologic (GYN) or breast cancer.

SECONDARY OBJECTIVE:

I. To determine the effects of the intervention on reducing fear of cancer progression (FOP) (primary outcome) and improving secondary outcomes of distress, anxiety, metacognitions, and mindfulness.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients 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: Patients 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.

After completion of study intervention, patients are followed up at 12 weeks.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Arcadia, California, United States, 91007
        • City of Hope at Arcadia
      • Duarte, California, United States, 91010
        • City of Hope Medical Center
      • Irvine, California, United States, 92618
        • City of Hope at Irvine Lennar
      • Lancaster, California, United States, 93534
        • City of Hope Antelope Valley
      • Long Beach, California, United States, 90813
        • City of Hope at Long Beach Elm
      • Long Beach, California, United States, 90808
        • City of Hope at Long Beach Worsham
      • Mission Hills, California, United States, 91345
        • City of Hope Mission Hills
      • Santa Clarita, California, United States, 91355
        • City of Hope - Santa Clarita
      • Simi Valley, California, United States, 93065
        • City of Hope at Simi Valley
      • Thousand Oaks, California, United States, 91361
        • City of Hope at Thousand Oaks
      • Torrance, California, United States, 90503
        • City of Hope South Bay
      • Upland, California, United States, 91786
        • City of Hope Upland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (Fear of progression intervention)
Patients 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.
Other: Survey Administration
Ancillary studies
Other: Interview
Ancillary studies
Behavioral: Behavioral Intervention
Attend online group sessions
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments
  • Behavioral
Behavioral: Behavioral Intervention
Complete online educational sessions
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments
  • Behavioral
Behavioral: Behavioral Intervention
Complete check in call
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments
  • Behavioral
Behavioral: Behavioral Intervention
Complete daily skills practice
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments
  • Behavioral
Other: Educational Intervention
Receive access to patient partner videos, testimonials, handouts and a community forum
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Other: Educational Intervention
Attend online group sessions
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Other: Educational Intervention
Complete online education sessions
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Other: Internet-Based Intervention
Receive access to Day to Day platform
Other: Internet-Based Intervention
Receive access to the Empower Hope platform
Other: Virtual Technology Intervention
Receive a tablet
Other Names:
  • Virtual Reality Intervention
  • Virtual Technology
Active Comparator: Arm II (Educational intervention)
Patients 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.
Other: Survey Administration
Ancillary studies
Other: Interview
Ancillary studies
Behavioral: Behavioral Intervention
Attend online group sessions
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments
  • Behavioral
Behavioral: Behavioral Intervention
Complete online educational sessions
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments
  • Behavioral
Behavioral: Behavioral Intervention
Complete check in call
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments
  • Behavioral
Behavioral: Behavioral Intervention
Complete daily skills practice
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments
  • Behavioral
Other: Educational Intervention
Receive access to patient partner videos, testimonials, handouts and a community forum
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Other: Educational Intervention
Attend online group sessions
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Other: Educational Intervention
Complete online education sessions
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Other: Internet-Based Intervention
Receive access to Day to Day platform
Other: Internet-Based Intervention
Receive access to the Empower Hope platform
Other: Virtual Technology Intervention
Receive a tablet
Other Names:
  • Virtual Reality Intervention
  • Virtual Technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear of cancer progression (FOP-SF)
Time Frame: Baseline, 6 weeks, up to 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer-related distress - Impact of Event Scale-R (IES-R)
Time Frame: Baseline, 6 weeks, Up to 12 weeks
The IES-R measures cancer-related distress. It consists of 22-likert-scale items representing 3 subscales: Intrusion; Avoidance; and Hyperarousal. Items are scored on a 0-4 response format. Total scores range from 0-88. A score of 24 or greater indicates clinical levels of distress. It demonstrates good internal consistency; a=.79-.92. The IES has been used in several studies with cancer patients. It has been found to be sensitive to change in these interventions (Butow et al. 2017).
Baseline, 6 weeks, Up to 12 weeks
Anxiety - PROMIS - Anxiety 8-a
Time Frame: Baseline, 6 weeks, Up to 12 weeks
This measures fear, worry, hyperarousal, and related somatic symptoms (Cella et al., 2010). It consists of 8 items scored on a 0-5 response format. Scores are standardized to continuous T scores with a mean of 50 and SD of 10; higher scores reflect higher distress. PROMIS T score thresholds for anxiety are less than 55 normal; 55-64 mild; 65-74 moderate; greater than or equal to 75 severe. Validity was established in a large sample of patients with chronic illnesses, including cancer. Construct validity was demonstrated using the anxiety scale from the MASQ as the convergent measure (r=.80) and the CES-D as the divergent measure (r=.75).
Baseline, 6 weeks, Up to 12 weeks
Metacognitive Beliefs - Metacognitions questionnaire (MCQ-18)
Time Frame: Baseline, 6 weeks, Up to 12 weeks
The MCQ assesses different beliefs about worry. We will use 18 items from three subscales of the parent MCQ-30 questionnaire a) positive beliefs about worry; b) negative beliefs about worry; and c) need to control thoughts. Items are scored on a 1-4 Likert scale. Subscale scores range from 6-24. Higher scores indicate more dysfunctional metacognitions. Internal consistency was a=.93 for the total score and ranged from .72-.93 for the subscale scores. It has been validated in cancer patients showing good convergent validit7 (Cook et al., 2014). Internal consistency of the subscales ranged from .73-.89 (pre-treatment) and .79-.91 (post-treatment).
Baseline, 6 weeks, Up to 12 weeks
Mindfulness - Five Facet Mindfulness Questionnaire (FFMQ-15)
Time Frame: Baseline, 6 weeks, Up to 12 weeks
FFMQ-15 assesses 5 facets of mindfulness: Observing, Describing, Acting with awareness, non-reactivity to inner experience, and non-judging of inner experience. Items are rated on a 5-point Likert scale ranging from 1-5 scale (never/ rarely to very often). Three items comprise each subscale. Subscale scores range from 3-15. Higher scores indicate greater mindfulness skills engagement. The measure is sensitive to change over the course of mindfulness-based cognitive therapy (Chambers et al., 2017). For scoring, the Observing subscale score is excluded based on psychometric testing data from previous research. The total FFMQ score is calculated by summing the 4 subscale scores. For the subscales, internal consistency is adequate (a=.66-.83) (Baer et al., 2006). The FFMQ has been used in studies of advanced cancer patients.
Baseline, 6 weeks, Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Anne Reb, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 16, 2026

Primary Completion (Estimated)

July 16, 2026

Study Completion (Estimated)

July 16, 2026

Study Registration Dates

First Submitted

October 16, 2025

First Submitted That Met QC Criteria

November 5, 2025

First Posted (Actual)

November 10, 2025

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24425 (Other Identifier: CITY OF Hope Medical Center)
  • P30CA033572 (U.S. NIH Grant/Contract)
  • NCI-2025-07274 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • R21CA293326 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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