NCT07741968 · City of Hope Medical Center
A Blended e-Health Intervention to Improve Fear of Progression in Women With Gynecologic or Breast Cancer
What this study is 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.
View original scientific description
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.
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
Recruitment rate will be sufficient if at least 45% of invited patients complete the screening questionnaire and are enrolled. Descriptive statistics will be used to analyze feasibility measures.
Attrition rate (Intervention feasibility)
Time frame: Up to 6 weeks
Attrition will be acceptable if the percentage of enrolled subjects who drop out does not exceed 30% by week 6. Descriptive statistics will be used to analyze feasibility measures.
Percentage of Attendance/Sessions Completed
Time frame: Up to 6 weeks
Percentage of Attendance: Defined as the proportion of enrolled participants who attend the intervention sessions according to the study protocol. Feasibility will be evaluated based on participant attendance and will be considered successful if predefined feasibility criteria are met. Sessions Completed: Defined as the average number of intervention sessions completed by participants during the study period. This measure will be used to assess participant engagement with the intervention. Feasibility will be considered successful if predefined feasibility criteria are met.
System Usability Scale survey (Acceptability)
Time frame: At week 6 (T2)
The System Usability Scale is a validated measure of system usability with scores ranging from 0 to 100, where higher scores indicate greater perceived usability. The mean score will be calculated among participants who complete the assessment. Acceptability and usability will be considered successful if the mean score meets predefined study criteria.
Engagement measures
Time frame: Up to 6 weeks
Number of Log-ins: Defined as the average number of times participants log in to the study website during the study period. Page Views: Defined as the average number of website pages viewed by participants during the study period. Total Time on Site: Defined as the average total time participants spend on the study website during the study period. Skills Video Access: Defined as the average number of times participants access skills practice videos during the study period. Time Spent Viewing Skills Videos: Defined as the average total time participants spend viewing skills practice videos during the study period. Most Frequently Visited Content: Defined as the website content or pages accessed most frequently by participants during the study period, measured by access frequency.
Themes From Open-Ended System Usability Scale Responses and Open-Ended Exit Interview Questions
Time frame: Up to 14 months
Defined as themes identified from participants' responses to open-ended System Usability Scale questions. Qualitative data will be analyzed using conventional content analysis to identify common perceptions, experiences, and suggestions regarding website usability. Defined as themes identified from participants' responses to open-ended exit interview questions. Qualitative data will be analyzed using conventional content analysis to identify participants' experiences, perceived benefits, barriers to engagement, and recommendations for improvement.
Change in fear of progression
Time frame: At baseline (T1), 6 weeks (T2), and 12 weeks (T3)
Measured using the Fear of Progression Questionnaire. Total scores range from 12 to 60, with higher scores indicating greater fear of cancer progression. Change from baseline will be assessed.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Arcadia, California
- Duarte, California
- Huntington Beach, California
- Irvine, California
- Lancaster, California
- Long Beach, California
- Santa Clarita, California
- Simi Valley, California
- South Pasadena, California
- Upland, California
- West Covina, California
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 10, 2026 · Source of record for eligibility and locations