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

Official title

An e-Health Intervention for Fear of Progression in Women With Gynecologic or Breast Cancer

Overview

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.

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.

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

Primary outcome measures

• 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)]

Secondary outcome measures (4)

• Change in cancer-specific distress [Time frame: At baseline (T1), 6 weeks (T2) and 12 weeks (T3).]
• Change in Anxiety (PROMIS Anxiety 8a): [Time frame: At Baseline (T1), 6 weeks (T2) and 12 weeks (T3).]
• Change in metacognitions [Time frame: At Baseline (T1), 6 weeks (T2) and 12 weeks (T3).]
• Change in mindfulness [Time frame: At Baseline T1, 6 weeks (T2) and 12 weeks (T3)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Supportive care

Study locations

United States · 2 centers

• City of Hope Medical Center — Duarte
• City of Hope at Irvine Lennar — Irvine

Identifiers

NCT: NCT07741968 · 260057 · NCI-2026-04005 · 260057 · P30CA033572 · R21CA293326

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗