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

NCT02514486 | Completed DMC

• 1 other identifier: UPCC 13114
• Study Type: observational
• Target: 332
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer(BC) Survivors

Outcome Measures

Primary Outcomes (1)

• Completion of Questionnaire

  2 years

Interventions

Questionnaire BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Breast cancer survivors

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Linda Jacobs, CRNP, PhD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2015
• First Posted: August 3, 2015
• Study Start: July 1, 2014
• Primary Completion: January 19, 2018
• Study Completion: January 19, 2018
• Last Updated: April 3, 2020

Record last verified: 2019-12

Locations

US (1)