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

City of Hope

Status: Enrolling

Conditions: Anatomic Stage IV Breast Cancer AJCC v8; Malignant Female Reproductive System Neoplasm; Triple-Negative Breast Carcinoma; Stage III Cervical Cancer AJCC v8; Stage III Vulvar Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Ovarian Carcinoma; Anatomic Stage I Breast Cancer AJCC v8; Endometrial Carcinoma; Stage IV Vulvar Cancer AJCC v8; Uterine Corpus Carcinosarcoma; Ovarian Carcinosarcoma; Anatomic Stage III Breast Cancer AJCC v8; Breast Mixed Epithelial/Mesenchymal Metaplastic Carcinoma; Stage IV Cervical Cancer AJCC v8; Breast Carcinoma; Stage IV Vaginal Cancer AJCC v8; Stage III Vaginal Cancer AJCC v8

Treatments: Other: Interview; Behavioral: Telephone-Based Intervention; Other: Best Practice; Other: Supportive Care; Other: Survey Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07741968

260057 (Other Identifier)

R21CA293326 (U.S. NIH Grant/Contract)

P30CA033572 (U.S. NIH Grant/Contract)

NCI-2026-04005 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVE:

I. To determine the feasibility and acceptability of a blended e-health intervention to manage FOP in patients with stage III or IV gynecologic (GYN) or breast cancer.

SECONDARY (EXPLORATORY) OBJECTIVE:

I. To determine the effects of the intervention on reducing fear of cancer progression (FOP) (primary outcome) and improving secondary outcomes of distress, anxiety, metacognitions, and mindfulness.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: 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.

ARM II: 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.

After completion of study intervention, patients are followed up at week 12.

Enrollment: 126 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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126 participants in 2 patient groups

Arm I (Mindful Living Program)

Experimental group

Description:

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.

Treatment:

Other: Survey Administration

Other: Supportive Care

Other: Supportive Care

Behavioral: Telephone-Based Intervention

Other: Interview

Other: Supportive Care

Arm II (Navigating Cancer Program)

Active Comparator group

Description:

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.

Treatment:

Other: Survey Administration

Other: Best Practice

Behavioral: Telephone-Based Intervention

Other: Interview