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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
The statistician will generate a password-protected randomization list to ensure blinding. The study team is blinded to assignment until this point. The study participants will be blinded to group assignment.

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Other: Interview
    Ancillary studies
  • Other: Supportive Care
    Participate in Mindful Living Program
    Other names:
    • Supportive Therapy
    • Symptom Management
    • Therapy, Supportive
  • Other: Supportive Care
    Complete skills practice
    Other names:
    • Supportive Therapy
    • Symptom Management
    • Therapy, Supportive
  • Other: Supportive Care
    Receive access to videos and website
    Other names:
    • Supportive Therapy
    • Symptom Management
    • Therapy, Supportive
  • Other: Survey Administration
    Ancillary studies
  • Behavioral: Telephone-Based Intervention
    Receive check-in call
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.
  • Other: Best Practice
    Participate in Navigating Cancer Program
    Other names:
    • standard of care
    • standard therapy
  • Other: Interview
    Ancillary studies
  • Other: Survey Administration
    Ancillary studies
  • Behavioral: Telephone-Based Intervention
    Receive check-in call

Recruiting Locations

City of Hope at Arcadia
Arcadia, California 91007
Contact:
Anne Reb, MD
626-218-4673
areb@coh.org

City of Hope Medical Center
Duarte, California 91010
Contact:
Anne Reb
626-218-4673
areb@coh.org

City of Hope at Seacliff
Huntington Beach, California 92648
Contact:
Anne Reb, MD
626-218-4673
areb@coh.org

City of Hope at Irvine Lennar
Irvine, California 92618
Contact:
Anne Reb
626-218-4673
areb@coh.org

City of Hope Antelope Valley
Lancaster, California 93534
Contact:
Anne Reb
626-218-4673
areb@coh.org

City of Hope at Long Beach Elm
Long Beach, California 90813
Contact:
Anne Reb, MD
626-218-4673
areb@coh.org

City of Hope at Santa Clarita
Santa Clarita, California 91355
Contact:
Anne Reb, MD
626-218-4673
areb@coh.org

City of Hope at Simi Valley
Simi Valley, California 93065
Contact:
Anne Reb
626-218-4673
areb@coh.org

City of Hope at South Pasadena
South Pasadena, California 91030
Contact:
Anne Reb, MD
626-218-4673
areb@coh.org

City of Hope at Upland
Upland, California 91786
Contact:
Anne Reb, MD
626-218-4673
areb@coh.org

City of Hope at West Covina
West Covina, California 91790
Contact:
Anne Reb, MD
626-218-4673
areb@coh.org

More Details

Status
Recruiting
Sponsor
City of Hope Medical Center

Study Contact

Detailed 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.