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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07741968
Status
Not Yet Recruiting

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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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

First listed
Aug 3, 2026
Start date
Feb 22, 2027
Status verified
Jul 2026
Primary completion
Jan 16, 2028
Completion
Jan 16, 2028

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm I (Mindful Living Program)
    Patients participate in the Mindful Living Program over 6 weeks consisting of group sessions over 60 minutes each during weeks 1, 3, and 6 and online sessions during weeks 2, 4, and 5. Patients also practice skills related to attention training, detached mindfulness, worry postponement, guided imagery, and other mindfulness practices 10-12 minutes daily for 6 days a week. Additionally, patients receive a check-in call over 15-20 minutes at week 3-4 and access to videos as well as a website containing a journal, community forum, and resource library on study.
  • Active Comparator: Arm II (Navigating Cancer Program)
    Patients participate in the Navigating Cancer Program over 6 weeks consisting of group sessions over 60 minutes each during weeks 1, 3, and 6 and online sessions during weeks 2, 4, and 5. Patients also receive a check-in call over 15-20 minutes at week 3-4.

Primary Outcome Measure

Recruitment rate (Feasibility of enrollment) [ Time Frame: Up to 18 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Anne Reb (PRINCIPAL_INVESTIGATOR)
City of Hope at Irvine LennarIrvineCalifornia92618
Anne Reb (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

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By condition
Breast cancerEndometrial cancerOvarian cancer
By specialty
OncologyBreast oncologyWomen's healthGynecologic oncology
By research site
City of Hope Medical Center· Duarte, CACity of Hope at Irvine Lennar· Irvine, CA

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