Health Trials

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

ConditionsAnatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Breast CarcinomaBreast Mixed Epithelial/Mesenchymal Metaplastic CarcinomaEndometrial CarcinomaMalignant Female Reproductive System NeoplasmOvarian CarcinomaOvarian CarcinosarcomaStage III Cervical Cancer AJCC v8Stage III Vaginal Cancer AJCC v8Stage III Vulvar Cancer AJCC v8Stage IV Cervical Cancer AJCC v8Stage IV Vaginal Cancer AJCC v8Stage IV Vulvar Cancer AJCC v8Triple-Negative Breast CarcinomaUterine Corpus Carcinosarcoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCity of Hope Medical Center

About this trial

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

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Best Practice
  • Interview
  • Supportive Care
  • Supportive Care
  • Supportive Care
  • Survey Administration
  • Telephone-Based Intervention

Treatment groups

126 Participants
are divided into 2 treatment groups

Sponsors and collaborators

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov