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

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.

Conditions

• 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

Interventions

OTHER

Internet-Based Intervention

Receive access to Day to Day platform

OTHER

Internet-Based Intervention

Receive access to the Empower Hope platform

OTHER

Interview

Ancillary studies

OTHER

Survey Administration

Ancillary studies

OTHER

Virtual Technology Intervention

Receive a tablet

BEHAVIORAL

Behavioral Intervention

Attend online group sessions

BEHAVIORAL

Behavioral Intervention

Complete online educational sessions

BEHAVIORAL

Behavioral Intervention

Complete check in call

BEHAVIORAL

Behavioral Intervention

Complete daily skills practice

OTHER

Educational Intervention

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

OTHER

Educational Intervention

Attend online group sessions

OTHER

Educational Intervention

Complete online education sessions

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Anne Reb · City of Hope Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-16

Primary Completion

2026-07-16

Completion

2026-07-16

Countries

• United States

Study Locations