Supporting Health Including Endocrine Treatment for Long Duration

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorDana-Farber Cancer Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • SHIELD portal

    Behavioral

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: SHIELD Portal InterventionalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Enrollment Yield

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.

Time frame
up to 3 weeks

Secondary outcomes

1

Assessment Completion Rate

Assessment completion rate is defined as the proportion of assessments completed to assessments offered.

Time frame
Up to 3 months
2

Patient Information Resources Access Rate

Patient information resources access rate is defined as the proportion of patient information resources accessed to the total number delivered.

Time frame
Up to 3 months
3

SHIELD Portal Access

The number of times the SHIELD portal is accessed per month.

Time frame
Up to 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dana-Farber Cancer Institute

Lead sponsor

Breast Cancer Research Foundation

Collaborator