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

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 6 months later Jan 16, 2028 → Aug 6, 2028
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Record History

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  1. Primary and study completion pushed from Jan 16, 2028 to Aug 6, 2028 Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 7 entries
    • Start date changed from estimate of Feb 22, 2027 to Sep 9, 2026
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Site contacts updated at 11 of 11 sites
  2. Recruitment opened
    • Trial sites expanded: 2 → 11 locations
    v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
City of Hope Medical Center
411 trials monitored
See 53 trials at risk
Breast Cancer
5,455 trials monitored
See 306 trials at risk
Ovarian Cancer
1,341 trials monitored
See 94 trials at risk
Sarcoma
1,027 trials monitored
See 70 trials at risk
and 3 more diseases
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.
Trial Details
NCT Number NCT07741968
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 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 +10 more
Related terms Breast Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms, Triple Negative Breast Neoplasms, Uterine Cervical Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
Enrollment 126 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov