What this study is
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.
What's being tested
- Best Practice
Intervention · OTHER
Participate in Navigating Cancer Program
- Interview
Intervention · OTHER
- Supportive Care
Intervention · OTHER
Participate in Mindful Living Program
- Supportive Care
Intervention · OTHER
Complete skills practice
- Supportive Care
Intervention · OTHER
Receive access to videos and website
- Survey Administration
Intervention · OTHER
- Telephone-Based Intervention
Intervention · BEHAVIORAL
Receive check-in call
Both Interview and Survey Administration
Ancillary studies
Study details
- Official title
- An e-Health Intervention for Fear of Progression in Women With Gynecologic or Breast Cancer
- Sponsor
- City of Hope Medical Center
- Conditions
- 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
- Enrolling
- 126 people
- Starts
- 2026-09-09
- Est. completion
- 2028-08-06
- Design
- Triple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (11)
11 openContact for every open site
- Anne Reb, MD · Contact6262184673areb@coh.org
City of Hope at Arcadia
Arcadia, California, United States
RecruitingCity of Hope Medical Center
Duarte, California, United States
- Anne Reb · Principal investigator
RecruitingCity of Hope at Seacliff
Huntington Beach, California, United States
RecruitingCity of Hope at Irvine Lennar
Irvine, California, United States
- Anne Reb · Principal investigator
RecruitingCity of Hope Antelope Valley
Lancaster, California, United States
RecruitingCity of Hope at Long Beach Elm
Long Beach, California, United States
RecruitingCity of Hope at Santa Clarita
Santa Clarita, California, United States
RecruitingCity of Hope at Simi Valley
Simi Valley, California, United States
RecruitingCity of Hope at South Pasadena
South Pasadena, California, United States
RecruitingCity of Hope at Upland
Upland, California, United States
RecruitingCity of Hope at West Covina
West Covina, California, United States
Recruiting
Study team
Sponsor
City of Hope Medical Center
Study ID 260057
Principal investigator
Anne Reb
City of Hope Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.