Recruiting

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

ClinicalTrials.gov IDNCT07741968

PhaseNA

Enrollment126

SponsorCity of Hope Medical Center

Age18 Years

SexFEMALE

I'm interested View official listing

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

About this study

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.

Interventions

Other: Best Practice — Participate in Navigating Cancer Program
Other: Interview — Ancillary studies
Other: Supportive Care — Participate in Mindful Living Program
Other: Supportive Care — Complete skills practice
Other: Supportive Care — Receive access to videos and website
Other: Survey Administration — Ancillary studies
Behavioral: Telephone-Based Intervention — Receive check-in call

Primary outcomes

Recruitment rate (Feasibility of enrollment) (Up to 18 months)
Attrition rate (Intervention feasibility) (Up to 6 weeks)
Percentage of Attendance/Sessions Completed (Up to 6 weeks)
System Usability Scale survey (Acceptability) (At week 6 (T2))
Engagement measures (Up to 6 weeks)
Themes From Open-Ended System Usability Scale Responses and Open-Ended Exit Interview Questions (Up to 14 months)
Change in fear of progression (At baseline (T1), 6 weeks (T2), and 12 weeks (T3))

Eligibility information

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

Study locations

City of Hope at Arcadia, Arcadia, California 91007 United States
City of Hope Medical Center, Duarte, California 91010 United States
City of Hope at Seacliff, Huntington Beach, California 92648 United States
City of Hope at Irvine Lennar, Irvine, California 92618 United States
City of Hope Antelope Valley, Lancaster, California 93534 United States
City of Hope at Long Beach Elm, Long Beach, California 90813 United States
City of Hope at Santa Clarita, Santa Clarita, California 91355 United States
City of Hope at Simi Valley, Simi Valley, California 93065 United States
City of Hope at South Pasadena, South Pasadena, California 91030 United States
City of Hope at Upland, Upland, California 91786 United States

Showing 10 of 11 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.