A Blended e-Health Intervention to Improve Fear of Progression in Women With Gynecologic or Breast Cancer
Recruiting · NCT07741968 · Interventional (participants receive a specific treatment) · Lead sponsor: City of Hope Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 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
Exclusion criteria
- 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
11 locations listed across 1 US state.
- City of Hope at Arcadia - Arcadia, California, United States
- City of Hope Medical Center - Duarte, California, United States
- City of Hope at Seacliff - Huntington Beach, California, United States
- City of Hope at Irvine Lennar - Irvine, California, United States
- City of Hope Antelope Valley - Lancaster, California, United States
- City of Hope at Long Beach Elm - Long Beach, California, United States
- City of Hope at Santa Clarita - Santa Clarita, California, United States
- City of Hope at Simi Valley - Simi Valley, California, United States
- City of Hope at South Pasadena - South Pasadena, California, United States
- City of Hope at Upland - Upland, California, United States
- City of Hope at West Covina - West Covina, California, United States