Virtual Mental Health Intervention for Breast Cancer

Not yet recruiting at 11 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Hospice, Major depression, Non-English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a virtual mental health program in helping women with high-risk or advanced gynecologic or breast cancer manage their fear of recurrence or progression. Participants will either use a specialized online platform with various mental health resources or receive educational sessions to support their well-being. Women who have had stage III or IV gynecologic or breast cancer for at least two months and experience significant fear about their cancer's progression may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to access innovative mental health resources tailored to participants' needs.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this virtual mental health intervention is safe for women with high risk or stage III-IV gynecologic or breast cancer?

A previous study found a virtual mental health program to be safe and easy for patients to use. Research shows that these online programs can help reduce negative feelings in breast cancer patients. Another study on a similar program found it practical and acceptable for users, with no major safety issues reported. While digital programs don't always improve quality of life, they generally pose no significant risks. This suggests that using a virtual mental health program is unlikely to cause harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Mental Health Intervention for breast cancer because it provides a novel way to address mental health challenges like fear of disease progression, using accessible online tools. Unlike traditional in-person therapy, this intervention offers a flexible virtual platform with patient partner videos, group sessions, and skills practices that patients can access from the comfort of their homes. Additionally, it focuses on teaching specific coping strategies, such as mindfulness and worry postponement, which are tailored to help patients manage anxiety more effectively. This approach not only makes mental health support more accessible but also empowers patients by integrating technology into their care, potentially enhancing their overall wellbeing.

What evidence suggests that this virtual mental health intervention is effective for addressing fear of progression in breast cancer patients?

Research has shown that digital tools can effectively reduce anxiety and depression in breast cancer patients. In this trial, participants in Arm I will receive a virtual mental health intervention aimed at reducing the fear of cancer progression. This intervention includes access to the Day by Day platform, which features patient partner videos, testimonials, and a community forum. Additionally, a review of several studies showed that internet-based programs can improve mental health in these patients. Participants in Arm II will receive an educational intervention through the Empower Hope platform, focusing on clinical trial participation and healthy living. Virtual reality has also been explored and shows promise in easing negative emotions. Overall, evidence suggests that online mental health programs can effectively manage fear and stress for those with cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Anne Reb

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for women with high risk or advanced stage gynecologic cancers (like ovarian, uterine, endometrial, vaginal, and vulvar) or breast cancer. It's designed to help those who are dealing with fear about their cancer progressing.

Inclusion Criteria

Score ≥ 34 on the Fear of Progression Short-Form, indicating dysfunctional levels

My cancer is either in remission or getting worse.

I am 18 or older and can read and understand English.

Exclusion Criteria

Enrolled in hospice

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)

I have been diagnosed with major depression based on the PHQ-9.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a virtual mental health intervention or educational intervention for 6 weeks

6 weeks

3 online group sessions, 3 online educational sessions, 1 check-in call

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Follow-up assessments at 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Mental Health Intervention

Trial Overview The study tests a virtual mental health program against an educational intervention. The goal is to see if the online support helps women manage anxiety about cancer recurrence better than just learning more about their condition.

How Is the Trial Designed?

Group I: Arm I (Fear of progression intervention) Experimental Treatment 6 Interventions

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 II: Arm II (Educational intervention) Active Control 6 Interventions

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.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07226102

Virtual Mental Health Intervention to Address Fear of ... This clinical trial tests feasibility, acceptability and how well a virtual mental health intervention, compared to enhanced usual care ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2841243

E-Health Intervention for Fear of Cancer Recurrence This randomized clinical trial examines the efficacy of a therapist-guided e-health intervention to reduce fear of cancer recurrence in a ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12352589/

Digital Interventions and Mental Health Outcomes in Patients ... This study aims to (1) characterize digital interventions targeting mental health outcomes in patients with cancer; (2) quantify their ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2352013225000201

Psychological effects of virtual reality intervention on breast ... To explore the efficacy and safety of virtual reality (VR) in relieving negative emotions in patients with breast cancer with different personalities. Methods.

5. oncologynurseadvisor.com oncologynurseadvisor.com/news/digital-approaches-improved-mental-health-outcomes-breast-cancer/

Digital Approaches Improved Mental Health Outcomes in ... A meta-analysis of studies demonstrated that internet-based interventions could reduce anxiety and depression in patients with breast cancer.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11997674/

Psychological effects of virtual reality intervention on breast ... To explore the efficacy and safety of virtual reality (VR) in relieving negative emotions in patients with breast cancer with different personalities.

7. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-13639-6

Assessing the impact of a self-guided digital intervention for ... This pilot, randomised waitlist-controlled trial aimed to evaluate the feasibility, acceptability, and safety of iConquerFear, a self-guided online FCR ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0272735824001417

Are digital psychological interventions for ... The results showed that the digital intervention did not lead to a significant improvement in psychological distress and quality of life for cancer patients.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9454975/

Digital and Interactive Health Interventions Minimize the ... Conclusions: Right at the end of therapy, DIHIs are effective at improving UE function, pain, anxiety, depression, and QoL in women with BC. VRBT has a greater ...