A Blended e-Health Intervention to Improve Fear of Progression in Women With Gynecologic or Breast Cancer

Recruiting now · Not applicable

Conditions studied: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Breast Carcinoma, Breast Mixed Epithelial/Mesenchymal Metaplastic Carcinoma, Endometrial Carcinoma, Malignant Female Reproductive System Neoplasm, Ovarian Carcinoma, Ovarian Carcinosarcoma, Stage III Cervical Cancer AJCC v8, Stage III Vaginal Cancer AJCC v8, Stage III Vulvar Cancer AJCC v8, Stage IV Cervical Cancer AJCC v8, Stage IV Vaginal Cancer AJCC v8, Stage IV Vulvar Cancer AJCC v8, Triple-Negative Breast Carcinoma, Uterine Corpus Carcinosarcoma

In brief

This clinical trial studies whether an intervention supported by technology (blended e-health intervention) works to improve fear of progression (FOP) in women with gynecologic or breast cancer. FOP is the fear patients experience from the possibility that their cancer could grow, spread, or get worse. Managing FOP is a leading unmet concern of cancer patients. High levels of FOP are associated with distress, depression, and increased health care costs, despite this, access to resources to address FOP remain limited. The blended e-health intervention in this trial offers remote group sessions along with online sessions to help patients access the information. Session content incorporates values-based goal setting and skills practices to manage unhelpful beliefs about worry and promote helpful coping behaviors. The sessions may help patients recognize unhelpful thoughts and behaviors which reinforce worry. A blended e-health intervention may be an effective way to improve FOP in women with gynecologic or breast cancer.

Key facts

Study ID

NCT07741968

Run by

City of Hope Medical Center

People needed

126

Starts

2027-02-22

Expected to finish

2028-01-16

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women with stage III or IV GYN (ovarian, endometrial, cervical, vulvar/vaginal) or breast cancer who are at least 2 months from initial diagnosis OR Women with stage I or II endometrial, ovarian, or breast cancer with carcinosarcoma histology OR Women with stage I or II 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 can be on active treatment or surveillance. They can be no evidence of disease (NED), recurrent or with progressive disease

You may not qualify if…

• Enrolled in hospice
• Ongoing uncontrolled active psychiatric condition that, in the opinion of the investigator, would interfere in the conduct of the study (e.g., mood disorders, psychosis disorders, or substance use), Major depression as assessed by Patient Health Questionnaire-9 (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)
• Current participation in a mind-body or mindfulness education program within the past six weeks

Where it is running

• City of Hope at Arcadia — Arcadia, California, United States (enrolling)
• City of Hope Medical Center — Duarte, California, United States (enrolling)
• City of Hope at Seacliff — Huntington Beach, California, United States (enrolling)
• City of Hope at Irvine Lennar — Irvine, California, United States (enrolling)
• City of Hope Antelope Valley — Lancaster, California, United States (enrolling)
• City of Hope at Long Beach Elm — Long Beach, California, United States (enrolling)
• City of Hope at Santa Clarita — Santa Clarita, California, United States (enrolling)
• City of Hope at Simi Valley — Simi Valley, California, United States (enrolling)
• City of Hope at South Pasadena — South Pasadena, California, United States (enrolling)
• City of Hope at Upland — Upland, California, United States (enrolling)
• City of Hope at West Covina — West Covina, California, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.