An interventional study of Best Practice and Interview in Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage III Breast Cancer AJCC v8, sponsored by City of Hope Medical Center. Recruiting at 11 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by City of Hope Medical Center · Not applicable, Interventional, and Supportive care
Among 89 studies in Breast Neoplasms by City of Hope Medical Center — 17 open to participants now, 39 under way, 1 of them phase 3. Breast Neoplasms · City of Hope Medical Center.
Among the 89 studies in Breast Neoplasms by City of Hope Medical Center, this one is the 9th largest by planned enrollment of the 76 interventional ones, is one of 5 that started in 2026, is one of 33 with no phase, reaches primary completion later than 32 of the 38 other live ones, and was the 87th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 126 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →17 of the 89 studies in Breast Neoplasms by City of Hope Medical Center are open now, in 1 country. Each count lists the studies.
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →89 studies; the count open now beside each. This study's row is marked.
First in 1994; this study’s year is marked. 5 started in 2026.
Median enrollment 36 across the 76 interventional studies, 219 across the 12 observational. Of the 43 that completed or were terminated, 14 (33%) have results posted.
City of Hope Medical Center is the lead sponsor of 677 studies on the registry; 181 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 12 (39%) have results posted.
13 of the studies in Breast Neoplasms by City of Hope Medical Center that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04661982City of Hope Medical CenterLong Term Follow-Up in Patients With Stage 0-IIIC Breast Cancer | 2026-11-24 |
| NCT01992432City of Hope Medical CenterBrain Functional MRI in Older Women With Breast Cancer (Brain fMRI-BC) | 2026-11-30 |
| NCT01450020City of Hope Medical CenterPeer Navigator Education in Improving Survivorship Care in African American Breast Cancer Survivors | 2027-01-01 |
| NCT01824745City of Hope Medical CenterSurvivorship Care Planning in Improving the Quality of Life in Breast Cancer Survivors | 2027-01-01 |
| NCT07664579City of Hope Medical CenterInvestigating the Feasibility and Acceptability of an Innovative Interdisciplinary Supportive Care Program: Couples Coping Together Against Cancer | 2027-01-04 |
Among the 89 studies in Breast Neoplasms by City of Hope Medical Center, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 · Other: Supportive Care · Other: Survey Administration · Behavioral: Telephone-Based Intervention
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 · Other: Interview · Other: Survey Administration · Behavioral: Telephone-Based Intervention
Participate in Navigating Cancer Program
Also known as: standard of care, standard therapy
Ancillary studies
Participate in Mindful Living Program
Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive
Complete skills practice
Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive
Receive access to videos and website
Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive
Ancillary studies
Receive check-in call
Recruitment rate (Feasibility of enrollment)
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.
Time frame: Up to 18 months
Attrition rate (Intervention feasibility)
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.
Time frame: Up to 6 weeks
Percentage of Attendance/Sessions Completed
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.
Time frame: Up to 6 weeks
System Usability Scale survey (Acceptability)
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.
Time frame: At week 6 (T2)
Engagement measures
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.
Time frame: Up to 6 weeks
Themes From Open-Ended System Usability Scale Responses and Open-Ended Exit Interview Questions
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.
Time frame: Up to 14 months
Change in fear of progression
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.
Time frame: At baseline (T1), 6 weeks (T2), and 12 weeks (T3)
Change in cancer-specific distress
Measured using a cancer-specific distress instrument. Total scores range from 0 to 88, with higher scores indicating greater cancer-related distress. Change from baseline will be assessed.
Time frame: At baseline (T1), 6 weeks (T2) and 12 weeks (T3).
Change in Anxiety (PROMIS Anxiety 8a):
Measured using the PROMIS Anxiety 8a scale. Scores range from 37.1 to 83.1, with higher scores indicating greater anxiety. Change from baseline will be assessed.
Time frame: At Baseline (T1), 6 weeks (T2) and 12 weeks (T3).
Change in metacognitions
Measured using the Metacognitions Questionnaire. Subscale scores range from 6 to 24, with higher scores indicating more dysfunctional beliefs about worry and metacognitive processes. Change from baseline will be assessed
Time frame: At Baseline (T1), 6 weeks (T2) and 12 weeks (T3).
Change in mindfulness
Measured using the Five Facet Mindfulness Questionnaire (FFMQ). Total scores range from 12 to 60, with higher scores indicating greater engagement with mindfulness skills and mindful awareness. Change from baseline will be assessed.
Time frame: At Baseline T1, 6 weeks (T2) and 12 weeks (T3)
Started Sep 2026 (actual). Primary completion is estimated for Aug 2028, 22 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 22 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 16, 2026: start Feb 2027 → Sep 2026, primary completion Jan 2028 → Aug 2028 and completion Jan 2028 → Aug 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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