Impact of Individualized Radiotherapy Plan Review in Patients Receiving Adjuvant Radiotherapy for Breast Cancer

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02366806
• Lead Sponsor: University of California, Davis

Brief Summary

This study is being conducted to investigate the effect of a more in-depth education plan for patients with breast cancer. Patients will be randomized to receive either the standard education plan during their breast cancer treatment or they will receive in-depth education about their breast cancer treatment. In order to see what kind of effect the different education plans have, patients will fill out three identical questionnaires during the course of treatment.

Detailed Description

This study will be a prospective study of women receiving adjuvant radiation therapy for management of breast cancer at the University of California Davis. All patients will be staged according to the American Joint Committee on Cancer Seventh edition. Primary disease treatment information including surgical approach and utilization of adjuvant chemotherapy will be evaluated.

All patients will have a validated quality of life assessment (FACIT-TS-PS) completed at three time points during their radiation therapy process. The patients will be randomized at the time of completion of radiation plan approval by the treating radiation oncologist in a one to one fashion to either proceed with standard education or more extensive plan review. The radiation oncology quality assurance (QA) process will be blinded to the randomization of the patient.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2015-02-06
• Study First Submitted QC: 2015-02-11
• Study First Posted: 2015-02-19
• Primary Completion: 2017-04-07
• Study Completion: 2017-04-07
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-26
• Last Update Posted: 2020-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Satisfaction measure	3 months	Questions on the survey will be analyzed to see if patients are more satisfied with the in-depth education compared to the standard education.

Secondary Outcome Measures

Name	Time	Method
Time measure	3 Months	The amount of time in the clinic office will be analyzed for the in-depth education plan as compared to the standard education plan.
Change in satisfaction over time	3 months	Questions on the survey will be analyzed from baseline to the end of treatment to see if there are differences over time between the in-depth education group and the standard education group.

Trial Locations

Locations (1)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States