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

Breast Cancer(BC) Survivors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02514486
• Other study ID #: UPCC 13114
• Status: Completed
• Start date: July 2014
• Est. completion date: January 19, 2018

Study information

• Verified date: December 2019
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: January 19, 2018
• Est. primary completion date: January 19, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Breast Cancer(BC) Survivors

Intervention

Behavioral:
• Questionnaire

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of Questionnaire		2 years