Recruiting

Blended E-Health Intervention

Sponsor:

City of Hope Medical Center

Code:

NCT07741968

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

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Best Practice

Interview

Supportive Care

Supportive Care

Supportive Care

Study Details

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.

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

Study ID

NCT07741968

Start date

Feb 22, 2027

Status verified date

Aug, 2026

Completion date

Jan 16, 2028

Anticipated

Primary completion date

Jan 16, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

126 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Best Practice

Participate in Navigating Cancer Program

Interview

Ancillary studies

Supportive Care

Participate in Mindful Living Program

Supportive Care

Complete skills practice

Supportive Care

Receive access to videos and website

Survey Administration

Ancillary studies

Telephone-Based Intervention

Receive check-in call

Primary outcome measure

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

Central Contacts and Locations

Locations

City of Hope at Arcadia

Recruiting

Arcadia, California, United States, 91007

Contacts

Anne Reb, MD

626-218-4673areb@coh.org

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Anne Reb

626-218-4673areb@coh.org

Principal Investigator:

Anne Reb

City of Hope at Seacliff

Recruiting

Huntington Beach, California, United States, 92648

Contacts

Anne Reb, MD

626-218-4673areb@coh.org

City of Hope at Irvine Lennar

Recruiting

Irvine, California, United States, 92618

Contacts

Anne Reb

626-218-4673areb@coh.org

Principal Investigator:

Anne Reb

City of Hope Antelope Valley

Recruiting

Lancaster, California, United States, 93534

Contacts

Anne Reb

626-218-4673areb@coh.org

City of Hope at Long Beach Elm

Recruiting

Long Beach, California, United States, 90813

Contacts

Anne Reb, MD

626-218-4673areb@coh.org

City of Hope at Santa Clarita

Recruiting

Santa Clarita, California, United States, 91355

Contacts

Anne Reb, MD

626-218-4673areb@coh.org

City of Hope at Simi Valley

Recruiting

Simi Valley, California, United States, 93065

Contacts

Anne Reb

626-218-4673areb@coh.org

City of Hope at South Pasadena

Recruiting

South Pasadena, California, United States, 91030

Contacts

Anne Reb, MD

626-218-4673areb@coh.org

Anne Reb, MD

6262184673areb@coh.org

City of Hope at Upland

Recruiting

Upland, California, United States, 91786

Contacts

Anne Reb, MD

626-218-4673areb@coh.org

City of Hope at West Covina

Recruiting

West Covina, California, United States, 91790

Contacts

Anne Reb, MD

626-218-4673areb@coh.org

More Information

Sponsor

City of Hope Medical Center

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-08-10.