126 Participants NeededMy employer runs this trial

Blended e-Health Intervention for Breast and Gynecologic Cancers

Recruiting at 10 trial locations
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: City of Hope Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a tech-supported program designed to help women with gynecologic or breast cancer manage their fear of the cancer worsening. High fear levels can lead to stress, depression, and increased healthcare costs. The program, called the Blended e-Health Intervention, includes group and online sessions that teach skills to manage worry and encourage positive coping behaviors. Women with stage III or IV gynecologic or breast cancer, or specific types of early-stage cancer, who struggle with fear might be a good fit for this trial. As an unphased trial, this study offers participants a unique opportunity to access innovative support strategies tailored to their needs.

What prior data suggests that this blended e-health intervention is safe for women with gynecologic or breast cancer?

Research shows that eHealth programs, like the one in this trial, are usually easy for patients to handle. Studies have found that these programs can enhance various aspects of a patient's well-being, including quality of life and mental health. In these studies, no major safety issues emerged. Patients often report positive experiences and few, if any, negative effects. This suggests that the blended eHealth approach is safe for most people. While individual experiences may vary, the evidence so far indicates a low risk of negative effects.12345

Why are researchers excited about this trial?

Researchers are excited about the Blended e-Health Intervention for breast and gynecologic cancers because it combines digital tools with traditional mindfulness practices, offering a holistic approach to cancer care. Unlike standard treatments, which often focus solely on medical procedures and drugs, this intervention integrates online sessions, community support, and mindfulness exercises to address emotional and mental well-being. The Mindful Living Program emphasizes attention training and worry management, while the Navigating Cancer Program offers structured guidance and support. This innovative approach aims to enhance quality of life and emotional resilience, providing a much-needed complement to conventional cancer treatments.

What evidence suggests that this trial's treatments could be effective for improving fear of progression in women with gynecologic or breast cancer?

This trial will compare two different eHealth programs for breast and gynecologic cancer patients. Studies have shown that eHealth programs can effectively improve breast cancer patients' quality of life, fatigue, and emotional stress. Research indicates that these programs lead to small to moderate improvements in anxiety, depression, and overall health-related quality of life. Specifically, a blended eHealth program may help reduce the fear of cancer recurrence in women with gynecologic or breast cancer. This type of program combines online resources with group sessions to teach skills like mindfulness and goal-setting, which are important for managing worry and encouraging positive coping behaviors. Mindfulness practices included in these programs have been found to reduce stress and depressive symptoms, especially benefiting those who feel more distressed. Participants in this trial will be assigned to either the Mindful Living Program or the Navigating Cancer Program, each offering unique approaches to support and skill-building.12345

Who Is on the Research Team?

AR

Anne Reb

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for women diagnosed with breast or gynecologic cancers (such as ovarian, uterine, cervical, vaginal, or vulvar cancer) who are experiencing fear about their cancer getting worse. Participants should be able to take part in online and phone-based sessions.

Inclusion Criteria

Score ≥ 34 on the Fear of Progression Short-Form, indicating dysfunctional levels
I am currently being treated, monitored, or have no evidence of disease.
I am at least 18 years old and can read and understand English.
See 1 more

Exclusion Criteria

Enrolled in hospice
Ongoing uncontrolled active psychiatric condition that would interfere with study conduct, including mood disorders, psychosis disorders, substance use, or major depression as assessed by PHQ-9
Non-English speaking
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 18 months

Treatment

Participants engage in a 6-week blended e-health intervention with group and online sessions to manage fear of progression

6 weeks
3 group sessions (in-person or virtual), 3 online sessions

Follow-up

Participants are monitored for changes in fear of progression, anxiety, metacognitions, mindfulness, and cancer-specific distress

6 weeks
1 follow-up assessment at week 12

What Are the Treatments Tested in This Trial?

Interventions

  • Blended e-Health Intervention

Trial Overview

The study tests a blended e-health program combining remote group meetings and online activities designed to help women manage fears about their cancer progressing. The intervention includes goal setting and coping skills training compared to usual supportive care.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (Mindful Living Program)Experimental Treatment4 Interventions
Group II: Arm II (Navigating Cancer Program)Active Control4 Interventions

Find a Clinic Near You

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

Cook and Move for Your Life, an eHealth intervention ...

In summary, we found that an online intervention delivered twice monthly over 6 months to early-stage breast cancer survivors successfully ...

Electronic Health Interventions for Patients With Breast Cancer

Overall, eHealth interventions were effective for improving patient-reported outcomes (quality of life, self-efficacy, fatigue, and psychologic distress),

Effectiveness of eHealth interventions in long-term follow-up ...

eHealth interventions were associated with small to moderate improvements in fatigue, anxiety, depression, HRQoL, and treatment adherence,

A Blended e-Health Intervention to Improve Fear of ...

A blended e-health intervention may be an effective way to improve FOP in women with gynecologic or breast cancer.

A Blended e-Health Intervention to Improve Fear of ...

A blended e-health intervention may be an effective way to improve FOP in women with gynecologic or breast cancer.