Anatomic Stage I Breast Cancer AJCC v8NCT07741968
A Blended e-Health Intervention to Improve Fear of Progression in Women With Gynecologic or Breast Cancer
A study testing Best Practice, Interview and Supportive Care in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by City of Hope Medical Center at 11 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- What is being tested?
- Best Practice, Interview and Supportive Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 11 sitesUnited States
- Study dates
- 9 Sep 2026to 6 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
City of Hope at Arcadia
Arcadia, California, 91007
Anne Reb, MD, 6262184673, areb@coh.org
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Anne Reb, 6262184673, areb@coh.org
Anne Reb
- Recruiting
City of Hope at Seacliff
Huntington Beach, California, 92648
Anne Reb, MD, 6262184673, areb@coh.org
- Recruiting
City of Hope at Irvine Lennar
Irvine, California, 92618
Anne Reb, 6262184673, areb@coh.org
Anne Reb
- Recruiting
City of Hope Antelope Valley
Lancaster, California, 93534
Anne Reb, 6262184673, areb@coh.org
- Recruiting
City of Hope at Long Beach Elm
Long Beach, California, 90813
Anne Reb, MD, 6262184673, areb@coh.org
- Recruiting
City of Hope at Santa Clarita
Santa Clarita, California, 91355
Anne Reb, MD, 6262184673, areb@coh.org
- Recruiting
City of Hope at Simi Valley
Simi Valley, California, 93065
Anne Reb, 6262184673, areb@coh.org
- Recruiting
City of Hope at South Pasadena
South Pasadena, California, 91030
Anne Reb, MD, 6262184673, areb@coh.org
- Recruiting
City of Hope at Upland
Upland, California, 91786
Anne Reb, MD, 6262184673, areb@coh.org
- Recruiting
City of Hope at West Covina
West Covina, California, 91790
Anne Reb, MD, 6262184673, areb@coh.org
About this study
Official title: An e-Health Intervention for Fear of Progression in Women With Gynecologic or Breast Cancer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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
- Being tested
- Best Practice, Interview, Supportive Care, Survey Administration, Telephone-Based Intervention
- Medical subject headings
- Breast Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Participate in Navigating Cancer Program
InterviewOther
Ancillary studies
Supportive CareOther
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Participate in Mindful Living Program
Supportive CareOther
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Complete skills practice
Supportive CareOther
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Receive access to videos and website
Survey AdministrationOther
Ancillary studies
Telephone-Based InterventionBehavioural
Receive check-in call
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Mindful Living Program) | Experimental | 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. Receives: Other: Interview; Other: Supportive Care; Other: Survey Administration; Behavioral: Telephone-Based Intervention |
| Arm II (Navigating Cancer Program) | Active comparator | 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. Receives: Other: Best Practice; Other: Interview; Other: Survey Administration; Behavioral: Telephone-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline (T1), 6 weeks (T2), and 12 weeks (T3)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: At Baseline T1, 6 weeks (T2) and 12 weeks (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start9 Sep 2026
- Primary completion6 Aug 2028 (estimated)
- Study completion6 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Anne Reb, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741968
- Sponsor's protocol ID
- 260057
- Other IDs
- NCI-2026-04005, 260057, P30CA033572, R21CA293326
- Status last verified
- Oct 2026
- First submitted
- 10 Jun 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An e-Health Intervention for Fear of Progression in Women With Gynecologic or Breast Cancer
- ClinicalTrials.gov ID
- NCT07741968
- Acronym / sponsor ID
- 260057
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- 6 Aug 2028 (estimated)
- Study completion
- 6 Aug 2028 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Mindful Living Program) | Experimental | Other: Interview, Other: Supportive Care, Other: Survey Administration, Behavioral: Telephone-Based InterventionPatients 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 (Navigating Cancer Program) | Active comparator | Other: Best Practice, Other: Interview, Other: Survey Administration, Behavioral: Telephone-Based InterventionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyParticipate in Navigating Cancer Program | Other | Arm II (Navigating Cancer Program) |
| InterviewAncillary studies | Other | Arm I (Mindful Living Program), Arm II (Navigating Cancer Program) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveParticipate in Mindful Living Program | Other | Arm I (Mindful Living Program) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveComplete skills practice | Other | Arm I (Mindful Living Program) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveReceive access to videos and website | Other | Arm I (Mindful Living Program) |
| Survey AdministrationAncillary studies | Other | Arm I (Mindful Living Program), Arm II (Navigating Cancer Program) |
| Telephone-Based InterventionReceive check-in call | Behavioural | Arm I (Mindful Living Program), Arm II (Navigating Cancer Program) |
Primary outcome
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.
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne Reb principal investigator
City of Hope Medical Center
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Interview and Supportive Care in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by City of Hope Medical Center at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (Feasibility of enrollment) (time frame: Up to 18 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.