Anatomic Stage 0 Breast Cancer AJCC v8YESNCT04906200
Web-Based Symptom Monitoring and Self-Management Portal (YES) for Adolescent and Young Adult Breast Cancer Survivors
A study testing Best Practice, Internet-Based Intervention and Survey Administration in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 3 sites in United States.
Trial summary
This clinical trial compares a web-based patient-reported symptom monitoring and self management portal, the Young, Empowered \& Strong (YES), to standard therapy in managing symptoms in adolescent and young adult breast cancer survivors. Read more about this study
- Who is it for?
- Ages 15 to 39 years, women only
- Conditions the study is for
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
- What is being tested?
- Best Practice, Internet-Based Intervention and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Jun 2021to 31 Dec 2026
- 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 15 to 39 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female
- Age 15-39 years at diagnosis of a stage 0-III breast cancer
- Within 3 years of breast cancer diagnosis
- No known evidence of breast cancer recurrence (local or distant) or second primary breast cancer
- No prior history of new other malignancy since their breast cancer diagnosis (other than non-melanoma skin cancer)
- Able to speak, understand and read English
Show all 10Show fewer
- Cognitively able to complete the study requirements
- Ability to access medical records from treating hospital
- Willing to provide cell phone number and/or email address, and willing to receive email and/or text messages from the study team either with their own smartphone or one provided by the study team if they do not have their own to use
- Pregnant survivors are also eligible for this protocol, given that fertility and pregnancy are important AYA issues
Who cannot join
- Individuals under age 15 or over age 42
- Stage IV or metastatic breast cancer
- Males with breast cancer are not being recruited to this protocol. In the AYA age group, only a miniscule proportion of breast cancers occur in males. For this reason, the YES portal intervention materials have been targeted for young women
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Randomized Controlled Trial of Young, Empowered &Amp; Strong (YES), a Web-Based Patient-Reported Symptom Monitoring and Self-Management Portal for Adolescent and Young Adult Breast Cancer Survivors
This clinical trial compares a web-based patient-reported symptom monitoring and self management portal, the Young, Empowered \& Strong (YES), to standard therapy in managing symptoms in adolescent and young adult breast cancer survivors. YES is a web-based portal (website) to help monitor issues or symptoms women with breast cancer may experience. The YES portal may improve the quality of life of young breast cancer survivors. The YES portal may help manage symptoms and provide useful information/resources.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the efficacy of the YES intervention compared to usual care in improving quality of life (QOL), as measured by the Quality of Life in Adult Cancer Survivors (QLACS) at 6-months (primary outcome).
II. To determine the efficacy of the YES intervention compared to usual care in reducing specific adolescent and young adult (AYA) breast cancer (BC) concerns and symptoms at 6-months.
III. To determine the sustainability of the effects of YES on AYA concerns, symptoms, and QOL at 9 months, after the completion of the 6-month active intervention period.
EXPLORATORY OBJECTIVE:
- To explore potential moderators and mediators of intervention efficacy, and to explore the potential effects of the intervention on inflammatory and other biomarkers including genetic profiles.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP A: Patients receive access to the YES portal for 9 months. Patients also complete surveys at baseline and 3, 6, and 9 months.
GROUP B: Patients receive usual care for 9 months. Patients also complete surveys at baseline and 3, 6, and 9 months. After 9 months, patients may also receive access to the YES portal for 3 months.
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
- Being tested
- Best Practice, Internet-Based Intervention, Survey Administration
- Medical subject headings
- Breast Carcinoma In Situ
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
Receive usual care
Internet-Based InterventionOther
Receive access to YES portal
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| Group A (YES portal) | Experimental | Patients receive access to YES portal for 9 months. Patients also complete surveys at baseline and 3, 6, and 9 months. Receives: Other: Internet-Based Intervention; Other: Survey Administration |
| Group B (usual care) | Active comparator | Patients receive usual care for 9 months. Patients also complete surveys at baseline and 3, 6, and 9 months. After 9 months, patients may also receive access to YES portal for 3 months. Receives: Other: Best Practice; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the Young, Empowered & Strong (YES) intervention in improving quality of life (QOL)
Will determine the efficacy of the YES intervention compared to usual care in improving QOL, as measured by the Quality of Life in Adult Cancer Survivors Scale at 6-months (primary outcome). The QLACS contains 47 items scored on a 1 (never) to 7 (always) scale. The 47 items are grouped into 12 domains (7 generic and 5 cancer-specific). A QLACS generic summary score is calculated by adding the 7 constituent domain scores, so that a lower score (range: 31-143) corresponds to higher QOL. A QLACS cancer-specific summary score (range: 16-99) is calculated by adding the constituent domain scores of all but the "benefits" domain. The benefits domain is scored separately (range: 4-28).
Measured: Up to 6 months
Secondary outcomes (3)
Efficacy of the YES intervention in reducing specific adolescent and young adult (AYA) breast confident (BC) concerns and symptoms at 6-months compared to baseline.
AYA concerns and symptoms will be measured by items from the AYA HOPE Study questionnaire that asks patients to indicate their need for information regarding a range of AYA survivorship-focused issues, including fertility, diet and nutrition, physical activity, weight management, survivorship care, recurrence concerns, and financial support for medical care. Symptoms assessed include sexual problems, anxiety, fatigue, stress, depression, sleep problems, hot flashes, and musculoskeletal complaints. Changes in concerns and symptoms will be examined using the frequencies of the report of needs and symptoms between baseline and 6 months. Lower frequencies of concerns and symptoms, as compared to their baseline levels, both indicate better outcomes.
Measured: Up to 6 months
Sustainability of the effects of YES on AYA concerns and symptoms
Frequencies of AYA concerns for information and frequencies of symptoms at 9 months will be compared to the same frequencies at 6 months (the end of the intervention period). Better outcomes will be the same or lower frequencies of AYA concerns and symptoms at 9 months, as compared to the 6-month assessment point.
Measured: Up to 9 months post-baseline, after the completion of the 6-month active intervention period
Quality of Life (QOL)
Determine the Sustainability of the effects of YES on participants' quality of life, as measured by the generic (range: 31-143) and cancer-specific (range: 16-99) summary scores of the Quality of Life in Adult Cancer Survivors scale, from month 6 to month 9. Sustainability will be determined by both subscale scores maintaining the same or lower scores at 9 months as compared to their respective scores at month 6.
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start28 Jun 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anatomic Stage 0 Breast Cancer AJCC v8Studies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Naughton, Ohio State University Comprehensive Cancer Center
- Investigators
- Michelle Naughton, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906200
- Sponsor's protocol ID
- OSU-21035
- Other IDs
- NCI-2021-03962, U01CA246648
- Acronym
- YES
- Status last verified
- Feb 2026
- First submitted
- 13 May 2021
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dibble KE, Rosenberg SM, Snow C, Kirkner GJ, Tayob N, Contreras M, Roma ND, DeGraffinreid CR, Nolan TS, Hershman DL, Naughton M, Partridge AH. Young, Empowered & strong (YES): a study protocol paper for a randomized controlled trial of an mHealth symptom monitoring and self-management intervention for adolescent and young adult (AYA) breast cancer survivors. BMC Public Health. 2025 Jan 11;25(1):126. doi: 10.1186/s12889-025-21288-4.
PubMed 39799291
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Young, Empowered &Amp; Strong (YES), a Web-Based Patient-Reported Symptom Monitoring and Self-Management Portal for Adolescent and Young Adult Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT04906200
- Acronym / sponsor ID
- YES / OSU-21035
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Dana-Farber Cancer Institute, Columbia University
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 May 2021 (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 compares a web-based patient-reported symptom monitoring and self management portal, the Young, Empowered \& Strong (YES), to standard therapy in managing symptoms in adolescent and young adult breast cancer survivors. YES is a web-based portal (website) to help monitor issues or symptoms women with breast cancer may experience. The YES portal may improve the quality of life of young breast cancer survivors. The YES portal may help manage symptoms and provide useful information/resources.
Detailed description
PRIMARY OBJECTIVES:
- To determine the efficacy of the YES intervention compared to usual care in improving quality of life (QOL), as measured by the Quality of Life in Adult Cancer Survivors (QLACS) at 6-months (primary outcome).
II. To determine the efficacy of the YES intervention compared to usual care in reducing specific adolescent and young adult (AYA) breast cancer (BC) concerns and symptoms at 6-months.
III. To determine the sustainability of the effects of YES on AYA concerns, symptoms, and QOL at 9 months, after the completion of the 6-month active intervention period.
EXPLORATORY OBJECTIVE:
- To explore potential moderators and mediators of intervention efficacy, and to explore the potential effects of the intervention on inflammatory and other biomarkers including genetic profiles.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP A: Patients receive access to the YES portal for 9 months. Patients also complete surveys at baseline and 3, 6, and 9 months.
GROUP B: Patients receive usual care for 9 months. Patients also complete surveys at baseline and 3, 6, and 9 months. After 9 months, patients may also receive access to the YES portal for 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (YES portal) | Experimental | Other: Internet-Based Intervention, Other: Survey AdministrationPatients receive access to YES portal for 9 months. Patients also complete surveys at baseline and 3, 6, and 9 months. |
| Group B (usual care) | Active comparator | Other: Best Practice, Other: Survey AdministrationPatients receive usual care for 9 months. Patients also complete surveys at baseline and 3, 6, and 9 months. After 9 months, patients may also receive access to YES portal for 3 months. |
Who may qualify
- Ages
- 15 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Female
- Age 15-39 years at diagnosis of a stage 0-III breast cancer
- Within 3 years of breast cancer diagnosis
- No known evidence of breast cancer recurrence (local or distant) or second primary breast cancer
- No prior history of new other malignancy since their breast cancer diagnosis (other than non-melanoma skin cancer)
Key exclusion criteria (3 listed)
- Individuals under age 15 or over age 42
- Stage IV or metastatic breast cancer
- Males with breast cancer are not being recruited to this protocol. In the AYA age group, only a miniscule proportion of breast cancers occur in males. For this reason, the YES portal intervention materials have been targeted for young women
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 therapyReceive usual care | Other | Group B (usual care) |
| Internet-Based InterventionReceive access to YES portal | Other | Group A (YES portal) |
| Survey AdministrationComplete survey | Other | Group A (YES portal), Group B (usual care) |
Primary outcome
Efficacy of the Young, Empowered & Strong (YES) intervention in improving quality of life (QOL)
Time frame: Up to 6 months
Will determine the efficacy of the YES intervention compared to usual care in improving QOL, as measured by the Quality of Life in Adult Cancer Survivors Scale at 6-months (primary outcome). The QLACS contains 47 items scored on a 1 (never) to 7 (always) scale. The 47 items are grouped into 12 domains (7 generic and 5 cancer-specific). A QLACS generic summary score is calculated by adding the 7 constituent domain scores, so that a lower score (range: 31-143) corresponds to higher QOL. A QLACS cancer-specific summary score (range: 16-99) is calculated by adding the constituent domain scores of all but the "benefits" domain. The benefits domain is scored separately (range: 4-28).
3 secondary outcomes
Efficacy of the YES intervention in reducing specific adolescent and young adult (AYA) breast confident (BC) concerns and symptoms at 6-months compared to baseline.
Time frame: Up to 6 months
Sustainability of the effects of YES on AYA concerns and symptoms
Time frame: Up to 9 months post-baseline, after the completion of the 6-month active intervention period
Quality of Life (QOL)
Time frame: Up to 9 months
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 19 Feb 2026.
- Background: PubMed 39799291Dibble KE, Rosenberg SM, Snow C, Kirkner GJ, Tayob N, Contreras M, Roma ND, DeGraffinreid CR, Nolan TS, Hershman DL, Naughton M, Partridge AH. Young, Empowered & strong (YES): a study protocol paper for a randomized controlled trial of an mHealth symptom monitoring and self-management intervention for adolescent and young adult (AYA) breast cancer survivors. BMC Public Health. 2025 Jan 11;25(1):126. doi: 10.1186/s12889-025-21288-4.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Michelle Naughton, PhD principal investigator
Ohio State University Comprehensive Cancer Center
3 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, Internet-Based Intervention and Survey Administration in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 3 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 10 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the Young, Empowered & Strong (YES) intervention in improving quality of life (QOL) (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04906200, which also lists 1 linked publication.
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 19 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.