Assessment of Cancer Concerns at the End of Treatment (ACE)

April 2, 2020 updated by: Abramson Cancer Center of the University of Pennsylvania
This study will describe patient-reported symptom burden and concerns, quality of life (QOL), and health behaviors of breast cancer(BC) survivors who have completed initial treatments (e.g., surgery, chemotherapy, and/or radiotherapy), assess the feasibility of using a web-based platform to collect patient-reported outcome (PRO) data, and evaluate provider satisfaction following delivery of an electronic health record (HER)/EPIC summary of these PROs. Secondary aims will estimate differences in referral to available services between those providers exposed to the PRO summary and historical controls. BC survivors who have completed initial treatment and present within the first year following treatment for an end of treatment (EOT)/survivorship focused visit will be the focus of this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

332

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of The University of Pennsylvania

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Breast cancer survivors

Description

Inclusion Criteria:

  1. Diagnosed with invasive, non-metastatic BC (Stage I, II, or III) without hematogenous or distant metastases
  2. Have completed initial treatment (chemotherapy, radiotherapy, and/or surgery). May still be receiving hormonal or targeted therapy (e.g., tamoxifen, aromatase inhibitors).
  3. Within 1 year of completing primary treatment
  4. Scheduled for an EOT visit
  5. Age 18 years or older
  6. Can understand written English
  7. Have internet access and a working email address

Exclusion Criteria:

  1. Diagnosed with non-invasive (Stage 0/DCIS) or metastatic (Stage IV) cancer or hematogenous or distant metastatic disease
  2. No working email address -

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Completion of Questionnaire
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Investigators

  • Principal Investigator: Linda Jacobs, CRNP, PhD, Abramson Cancer Center of The University of Pennsylvania

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

July 1, 2014

Primary Completion (Actual)

January 19, 2018

Study Completion (Actual)

January 19, 2018

Study Registration Dates

First Submitted

July 31, 2015

First Submitted That Met QC Criteria

July 31, 2015

First Posted (Estimate)

August 3, 2015

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 2, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • UPCC 13114

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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