Breast Cancer, Breast Cancer - Female, Breast Carcinoma, ER Positive Breast Cancer, PR-Positive Breast Cancer
Conditions
Keywords
Breast cancer, Breast cancer female, Breast carcinoma, ER+, SHIELD
Brief summary
This research is being done to pilot an intervention which aims to test a new web- and mobile application ("app")-based supportive care tool (SHIELD portal) and to assess the feasibility of enrolling female breast cancer patients with hormone receptor-positive disease long-term endocrine treatment.
Detailed description
This research study is a single-arm intervention pilot study to assess the feasibility of enrolling female breast cancer patients with hormone receptor-positive disease prescribed long-term endocrine treatment. The SHIELD portal is designed to help monitor the frequency and variation in cancer and treatment-related issues and to share self-management information and resources to those interested in particular issues or who indicate a specific concern, symptom or side effect on measures designed to assess and track salient symptoms. Research study procedures include screening for eligibility, in-clinic and virtual approaches for recruitment, gaining access and using the SHIELD web- and mobile app-based supportive care portal, and completing of survey assessments on the SHIELD portal. Participation in this research study is expected to last 3 months. It is expected that 30 people will take part in this research study.
Interventions
BEHAVIORALSHIELD portal
All participants will receive access to the SHIELD portal. The portal includes educational modules, symptom and side effect tracking, tailored informational resources, and health behavior tools. Participants can access the portal via smartphone, tablet, or computer. The portal is HIPAA compliant and HITRUST certified.
Sponsors
Dana-Farber Cancer Institute
Breast Cancer Research Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Feasibility single-arm pilot study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
Participants will be eligible if they meet the following eligibility criteria: * Female * Age 18-49 years at diagnosis of a stage 0-IIIa, HR+ breast cancer * Premenopausal * In active treatment (including long-term endocrine therapy) at the time of enrollment * Able to speak, understand and read English * Access to a US-based mobile phone number * Cognitively able to complete study requirements * Ability to access medical records from treating hospital (DFCI) * Willing to provide cell phone number and/or email address and willing to receive email, mobile push notifications, and/or text messages from the study team
Exclusion criteria
Participants will be ineligible if they meet any of the following criteria: * Individuals under age 18 or over age 50 at initial breast cancer diagnosis * Stage IV or metastatic breast cancer * Pregnant patients * Individuals who do not have a US mobile phone number * Males with breast cancer are not being recruited to this protocol. In the adolescent and young adult (AYA) age group, only a miniscule proportion of breast cancers occur in males. Additionally, this pilot focuses on breast cancer treatment utilizing OFS and ET, both of which do not apply to males. For this reason, the SHIELD portal intervention materials have been targeted for young women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment Yield | up to 3 weeks | Enrollment yield is defined as the proportion of participants approached for the study intervention (SHIELD, Supporting Health Including Endocrine Treatment for Long Duration) who enroll. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment Completion Rate | Up to 3 months | Assessment completion rate is defined as the proportion of assessments completed to assessments offered. |
| Patient Information Resources Access Rate | Up to 3 months | Patient information resources access rate is defined as the proportion of patient information resources accessed to the total number delivered. |
| SHIELD Portal Access | Up to 3 months | The number of times the SHIELD portal is accessed per month. |
Countries
United States
Contacts
CONTACTAnn H Partridge, MD, MPH
CONTACTKate Dibble, Ph.D.
PRINCIPAL_INVESTIGATORAnn H Partridge, MD, MPH
Dana-Farber Cancer Institute
Outcome results
None listed