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

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.

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.

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)