Post-Treatment Surveillance in Breast Cancer: Bringing CER to the Alliance

December 22, 2022 updated by: University of Wisconsin, Madison

Post-Treatment Surveillance in Breast Cancer: Bringing Cost Effectiveness Research (CER) to the Alliance

Nearly three million living women have survived breast cancer. Physicians rely on clinical practice guidelines to make decisions on follow-up care. Among other things, the goal is to monitor for recurrence or side effects of treatment among survivors. It is unclear whether these guidelines represent the best approach for any given patient as they do not account for differences in disease or patient preferences and may not consider recent advances in imaging and treatment options. We seek to develop a new approach to surveillance following breast cancer treatment which will be more patient-centered and effective than the existing one-size-fits-all approach and will consider individual risk factors.

Study Overview

Status

Completed

Conditions

Detailed Description

Our project involves three primary goals:

  1. Use existing data from clinical trials sponsored by one of the leading cancer cooperative groups to evaluate how risk of recurrence and side effects of treatment vary based on patient and cancer characteristics.
  2. Use existing data to evaluate the effectiveness of the latest imaging technology for improving survival in patients previously treated for breast cancer.
  3. Engage cancer survivors, providers, and health outcomes researchers in the development of an improved patient-centered approach to guide post-treatment care, as well as identification of the highest priority strategies for prospective randomized trials.

Methods Our methods have been developed based on input from patients and other stakeholders who identified the need for a large-scale observational study. The goal is to produce timely results, and guide the development of an improved approach to surveillance that recognizes individual patient risk factors and allows for design of future prospective studies. This study analyzes recurrence data and treatment side effects on over 22,000 patients involved in past clinical trials on breast cancer care. The project also involves the analysis of existing data (n=15,000 patients) from a national cancer registry (National Cancer Database) to evaluate whether new imaging technology, beyond mammography, are able to detect recurrence earlier and improve survival. Finally, we will engage cancer survivors, health care providers, and researchers to develop new guidance for the care and monitoring of breast cancer survivors, and to guide and prioritize future prospective trials.

Study Type

Observational

Enrollment (Actual)

34359

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin-Madison School of Medicine and Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Research Aim 1: Patients who have participated in 1 of 15 closed clinical trials; Research Aim 2: National Cancer Database (NCDB); Research Aim 3: Purposive sample of breast cancer survivor, breast cancer treatment provider, and cancer health services researcher stakeholders

Description

Inclusion Criteria:

  • Women (all Aims)
  • Diagnosis of breast cancer (Aims 1 & 2)
  • American Joint Committee on Cancer (AJCC) stages I-III (Aim 1) AJCC stages II-III (Aim 2)
  • Patient, health care provider, and researcher stakeholders (Aim 3)

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Alliance for Clinical Trials Database
Use existing data from clinical trials sponsored by one of the leading cancer cooperative groups to evaluate how risk of recurrence and side effects of treatment vary based on patient and cancer characteristics.
National Cancer Database
Use existing data to evaluate the effectiveness of the latest imaging technology for detecting recurrence and improving survival in patients previously treated for breast cancer.
Stakeholder Engagement
Engage cancer survivors, providers, and health outcomes researchers in the development of an improved patient-centered approach to guide post-treatment care, as well as identification of the highest priority strategies for prospective randomized trials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Recurrence
Time Frame: 5 Years from Diagnosis
Data elements include the date and site of recurrence, type of recurrence (e.g., local/regional or distant recurrence), and progression.
5 Years from Diagnosis
Time to Toxicity/Side Effects of Treatment
Time Frame: Within relevant timeframe of legacy clinical trial. Most trials include 2-year follow-up

Legacy clinical trials contain detailed data on treatment toxicity and complications. Most trials include 2-year follow-up to determine the prevalence and time to presentation for each of the following toxicities: lymphedema, cardiotoxicity, and pneumonitis

Safety Issue?:

No
Within relevant timeframe of legacy clinical trial. Most trials include 2-year follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Death
Time Frame: Within 5 years from time of diagnosis
Within 5 years from time of diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

Patient-Centered Outcomes Research Institute
M.D. Anderson Cancer Center
Alliance for Clinical Trials in Oncology
Dana-Farber Cancer Institute
University of North Carolina, Chapel Hill
Harvard University
American College of Surgeons

Investigators

  • Principal Investigator: Caprice C Greenberg, MD MPH, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

June 19, 2014

First Submitted That Met QC Criteria

June 20, 2014

First Posted (Estimate)

June 23, 2014

Study Record Updates

Last Update Posted (Estimate)

December 26, 2022

Last Update Submitted That Met QC Criteria

December 22, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-0742 (Other Grant/Funding Number: Swedish Research Council for Health,Working Life and Welfare)
  • SMPH/SURGERY/SURG ONC (Other Identifier: UW Madison)
  • A539713 (Other Identifier: UW Madison)
  • CE-1304-6543 (Other Grant/Funding Number: Patient Centered Outcomes Research Institute)
  • UW14041 (Other Identifier: University of Wisconsin Carbone Cancer Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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