Supporting Health Including Endocrine Treatment for Long Duration

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое SHIELD 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.

Первичные конечные точки

• Enrollment Yield [Срок оценки: up to 3 weeks]

Вторичные конечные точки (3)

• Assessment Completion Rate [Срок оценки: Up to 3 months]
• Patient Information Resources Access Rate [Срок оценки: Up to 3 months]
• SHIELD Portal Access [Срок оценки: Up to 3 months]

Критерии участия

Критерии включения

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

Критерии исключения

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
• Patients with breast cancer who are not being treated with ET
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Dana-Farber Cancer Institute — Boston

Идентификаторы

NCT: NCT07482384 · 25-771

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗