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

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
• 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

Interventions

OTHER

Best Practice

Participate in Navigating Cancer Program

OTHER

Interview

Ancillary studies

OTHER

Supportive Care

Participate in Mindful Living Program

OTHER

Supportive Care

Complete skills practice

OTHER

Supportive Care

Receive access to videos and website

OTHER

Survey Administration

Ancillary studies

BEHAVIORAL

Telephone-Based Intervention

Receive check-in call

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Anne Reb · City of Hope Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2027-02-22

Primary Completion

2028-01-16

Completion

2028-01-16

Countries

• United States

Study Locations