- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04906200
Web-Based Symptom Monitoring and Self-Management Portal (YES) for Adolescent and Young Adult Breast Cancer Survivors (YES)
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
Study Overview
Status
Conditions
- 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
- Anatomic Stage IIB Breast Cancer AJCC v8
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Anatomic Stage IIIB Breast Cancer AJCC v8
- Anatomic Stage IIIC Breast Cancer AJCC v8
- Prognostic Stage I Breast Cancer AJCC v8
- Prognostic Stage IA Breast Cancer AJCC v8
- Prognostic Stage IB Breast Cancer AJCC v8
- Prognostic Stage II Breast Cancer AJCC v8
- Prognostic Stage IIA Breast Cancer AJCC v8
- Prognostic Stage IIB Breast Cancer AJCC v8
- Prognostic Stage III Breast Cancer AJCC v8
- Prognostic Stage IIIA Breast Cancer AJCC v8
- Prognostic Stage IIIB Breast Cancer AJCC v8
- Prognostic Stage IIIC Breast Cancer AJCC v8
- Anatomic Stage 0 Breast Cancer AJCC v8
- Prognostic Stage 0 Breast Cancer AJCC v8
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. 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:
I. 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 to 2 groups.
GROUP A: Patients receive access to 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 YES portal for 3 months.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Dana Farber Cancer Institute
-
Contact:
- Ann Partridge, M.D.
- Phone Number: 617-582-7942
- Email: Ann_Partridge@dfci.harvard.edu
-
Contact:
- Craig Snow, MHA
- Phone Number: 617-582-7942
- Email: craig_snow@dfci.harvard.edu
-
Principal Investigator:
- Ann H Partridge, MD
-
-
New York
-
New York, New York, United States, 10032
- Recruiting
- Columbia University Medical Center
-
Contact:
- Dawn Hershman, MD, MS
- Phone Number: 212-305-1945
- Email: dlh23@cumc.columbia.edu
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Recruiting
- Ohio State University Comprehensive Cancer Center
-
Contact:
- Michelle Naughton, PhD
- Phone Number: 614-293-6390
- Email: Michelle.Naughton@osumc.edu
-
Principal Investigator:
- Michelle Naughton, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A (YES portal)
Patients receive access to YES portal for 9 months.
Patients also complete surveys at baseline and 3, 6, and 9 months.
|
Complete survey
Receive access to YES portal
|
Active Comparator: Group B (usual care)
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.
|
Receive usual care
Other Names:
Complete survey
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
|
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.
|
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
|
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.
|
Up to 9 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Potential effects of the intervention on inflammatory and other biomarkers and genetic profiles
Time Frame: Baseline and 6 months
|
We will measure pro- and anti-inflammatory cytokines (IL1β, IL6, IL8, IL10, TNF- α, and CRP) from participants' blood samples.
We will also evaluate pro-inflammatory cytokine genes using microarray-based genome-wide transcriptional profiling to identify genes that show differential expression in leukocytes, aiming to accurately identify activation of specific transcription control pathways, including the pro-inflammatory NF-kB and decreased GR signaling.
These pathways are hypothesized to underlie increased inflammatory activity, which may be more sensitive to our intervention than circulating cytokines, with improved symptom control and improved quality of life.
|
Baseline and 6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michelle Naughton, PhD, Ohio State University Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSU-21035
- NCI-2021-03962 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U01CA246648 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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