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

NCT ID: NCT07226102

Last Updated: 2025-11-10

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-19

Study Completion Date

2026-07-16

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IV Breast Cancer AJCC v8 Endometrial Carcinoma Endometrial Endometrioid Adenocarcinoma Female Reproductive System Neoplasm Stage II Ovarian Cancer AJCC v8 Stage III Ovarian Cancer AJCC v8 Stage III Vaginal Cancer AJCC v8 Stage III Vulvar Cancer AJCC v8 Stage IV Ovarian Cancer AJCC v8 Stage IV Vaginal Cancer AJCC v8 Stage IV Vulvar Cancer AJCC v8 Triple-Negative Breast Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers
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).

Study Groups

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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.

Group Type EXPERIMENTAL

Behavioral Intervention

Intervention Type BEHAVIORAL

Attend online group sessions

Behavioral Intervention

Intervention Type BEHAVIORAL

Complete online educational sessions

Behavioral Intervention

Intervention Type BEHAVIORAL

Complete check in call

Behavioral Intervention

Intervention Type BEHAVIORAL

Complete daily skills practice

Educational Intervention

Intervention Type OTHER

Receive access to patient partner videos, testimonials, handouts and a community forum

Internet-Based Intervention

Intervention Type OTHER

Receive access to Day to Day platform

Interview

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Virtual Technology Intervention

Intervention Type OTHER

Receive a tablet

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.

Group Type ACTIVE_COMPARATOR

Behavioral Intervention

Intervention Type BEHAVIORAL

Complete check in call

Educational Intervention

Intervention Type OTHER

Attend online group sessions

Educational Intervention

Intervention Type OTHER

Complete online education sessions

Internet-Based Intervention

Intervention Type OTHER

Receive access to the Empower Hope platform

Interview

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Virtual Technology Intervention

Intervention Type OTHER

Receive a tablet

Interventions

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Behavioral Intervention

Attend online group sessions

Intervention Type BEHAVIORAL

Behavioral Intervention

Complete online educational sessions

Intervention Type BEHAVIORAL

Behavioral Intervention

Complete check in call

Intervention Type BEHAVIORAL

Behavioral Intervention

Complete daily skills practice

Intervention Type BEHAVIORAL

Educational Intervention

Receive access to patient partner videos, testimonials, handouts and a community forum

Intervention Type OTHER

Educational Intervention

Attend online group sessions

Intervention Type OTHER

Educational Intervention

Complete online education sessions

Intervention Type OTHER

Internet-Based Intervention

Receive access to Day to Day platform

Intervention Type OTHER

Internet-Based Intervention

Receive access to the Empower Hope platform

Intervention Type OTHER

Interview

Ancillary studies

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Virtual Technology Intervention

Receive a tablet

Intervention Type OTHER

Other Intervention Names

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Behavior Conditioning Therapy Behavior Modification Behavior or Life Style Modifications Behavior Therapy Behavioral Behavioral Interventions Behavioral Modification Behavioral Therapy Behavioral Treatment Behavioral Treatments Behavior Conditioning Therapy Behavior Modification Behavior or Life Style Modifications Behavior Therapy Behavioral Behavioral Interventions Behavioral Modification Behavioral Therapy Behavioral Treatment Behavioral Treatments Behavior Conditioning Therapy Behavior Modification Behavior or Life Style Modifications Behavior Therapy Behavioral Behavioral Interventions Behavioral Modification Behavioral Therapy Behavioral Treatment Behavioral Treatments Behavior Conditioning Therapy Behavior Modification Behavior or Life Style Modifications Behavior Therapy Behavioral Behavioral Interventions Behavioral Modification Behavioral Therapy Behavioral Treatment Behavioral Treatments Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Virtual Reality Intervention Virtual Technology

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Reb

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope at Arcadia

Arcadia, California, United States

Site Status

City of Hope Medical Center

Duarte, California, United States

Site Status

City of Hope at Irvine Lennar

Irvine, California, United States

Site Status

City of Hope Antelope Valley

Lancaster, California, United States

Site Status

City of Hope at Long Beach Worsham

Long Beach, California, United States

Site Status

City of Hope at Long Beach Elm

Long Beach, California, United States

Site Status

City of Hope Mission Hills

Mission Hills, California, United States

Site Status

City of Hope - Santa Clarita

Santa Clarita, California, United States

Site Status

City of Hope at Simi Valley

Simi Valley, California, United States

Site Status

City of Hope at Thousand Oaks

Thousand Oaks, California, United States

Site Status

City of Hope South Bay

Torrance, California, United States

Site Status

City of Hope Upland

Upland, California, United States

Site Status

Countries

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United States

Facility Contacts

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Anne Reb

Role: primary

Anne Reb

Role: primary

Anne Reb

Role: primary

Anne Reb

Role: primary

Anne Reb

Role: primary

Anne Reb

Role: primary

Anne Reb

Role: primary

Anne Reb

Role: primary

Anne Reb

Role: primary

Anne Reb

Role: primary

Anne Reb

Role: primary

Anne Reb

Role: primary

Other Identifiers

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NCI-2025-07274

Identifier Type: REGISTRY

Identifier Source: secondary_id

24425

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R21CA293326

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24425

Identifier Type: -

Identifier Source: org_study_id