NCT07226102

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

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

Type	Name	Description
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
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

Timeline

• Start date: 2026-07-16
• Primary completion: 2026-07-16
• Completion: 2026-07-16
• First posted: 2025-11-10
• Last updated: 2026-02-04

Locations

12 sites across 1 country: United States