NCT07741968 A Blended e-Health Intervention to Improve Fear of Progression in Women With Gynecologic or Breast Cancer
| NCT ID | NCT07741968 |
| Status | Recruiting |
| Phase | — |
| Sponsor | City of Hope Medical Center |
| Condition | Anatomic Stage I Breast Cancer AJCC v8 |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2027-02-22 |
| Primary Completion | 2028-01-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 126 participants in total. It began in 2027-02-22 with a primary completion date of 2028-01-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Anne Reb
PRINCIPAL INVESTIGATOR
City of Hope Medical Center
Frequently Asked Questions
Who can join the NCT07741968 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Anatomic Stage I Breast Cancer AJCC v8. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07741968 currently recruiting?
Yes, NCT07741968 is actively recruiting participants. Visit ClinicalTrials.gov or contact City of Hope Medical Center to inquire about joining.
Where is the NCT07741968 trial being conducted?
This trial is being conducted at Arcadia, United States, Duarte, United States, Huntington Beach, United States, Irvine, United States and 7 additional locations.
Who is sponsoring the NCT07741968 clinical trial?
NCT07741968 is sponsored by City of Hope Medical Center. The principal investigator is Anne Reb at City of Hope Medical Center. The trial plans to enroll 126 participants.
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