Status:

COMPLETED

Effect of PACK Health Support Program on Patient Reported Outcomes in Patients With Breast Cancer

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Carcinoma

Breast Ductal Carcinoma In Situ

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

This trial studies the effect of an electronic health (eHealth) support program called PACK Health on patient reported health outcomes in patients with breast cancer. PACK Health monitors breast cance...

Detailed Description

PRIMARY OBJECTIVE: I. To evaluate the effect of an eHealth coaching program on the self-reported global health of women with breast cancer, as measured by the National Institutes of Health (NIH) Pati...

Eligibility Criteria

Inclusion

  • Age 18 years and older
  • Able to read, speak and consent in English.
  • Individuals with a diagnosis of:
  • First time diagnosis of invasive breast cancer,
  • Ductal carcinoma in situ (DCIS),
  • Recurrent breast cancer off all therapy prior to recurrence
  • Currently starting or undergoing active treatment
  • Internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments.

Exclusion

  • Male patients (due to the small number of male breast cancer patients treated annually).
  • Individuals for whom there is documentation of inability to provide consent in the medical record.
  • Patients who were previously enrolled on protocol 2016-0761.

Key Trial Info

Start Date :

July 31 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 27 2023

Estimated Enrollment :

287 Patients enrolled

Trial Details

Trial ID

NCT04022772

Start Date

July 31 2019

End Date

July 27 2023

Last Update

August 7 2023

Active Locations (1)

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1

M D Anderson Cancer Center

Houston, Texas, United States, 77030