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Supporting Health Including Endocrine Treatment for Long Duration

Supporting Health Including Endocrine Treatment for Long Duration: A Pilot Intervention

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 49 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests SHIELD, a website and phone app that offers support during breast cancer care. It is for women who have not gone through menopause and have breast cancer that uses hormones to grow. The study also checks how practical it is to enroll women receiving long-term hormone treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Female and age 18–49 when diagnosed with stage 0–IIIa breast cancer that uses hormones to grow.
  • Have not gone through menopause.
  • Getting cancer treatment when joining, including long-term hormone treatment.
  • Can speak, understand, and read English.
  • Have access to a U.S. mobile phone number.
  • Can understand and complete study tasks.
  • Can access medical records from the treating hospital, DFCI.
  • Willing to share a cell phone number or email address and receive study emails, app alerts, or text messages.

Who can't join

  • Under age 18 or over age 50 when first diagnosed with breast cancer. Note: the entry rules above say age 18–49.
  • Have stage IV breast cancer, or cancer that has spread to distant parts of the body.
  • Are pregnant.
  • Do not have a U.S. mobile phone number.
  • Are male.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

MA