Breast Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

Inclusion Criteria

Diagnosis of invasive breast cancer
AJCC stage 1, 2, 3 breast carcinoma
Patient deemed clinically appropriate for adjuvant breast or chest wall radiation following surgery
Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
Patient must provide study specific informed consent prior to study entry
Breast implants allowed

Exclusion Criteria

Stage 4 breast cancer
Ductal carcinoma in situ
Patients treated with radiation for palliative intent
Prior treatment with radiation therapy to the ipsilateral breast or chest wall
Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to study entry
Prior invasive or in-situ carcinoma of the breast (-prior LCIS is eligible)
Diagnosis of DCIS

Study is for people with:

Breast Cancer

Estimated Enrollment:

72

Study ID:

NCT02366806

Recruitment Status:

Completed

Sponsor:

University of California, Davis

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There is 1 Location for this study

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UC Davis Medical Center
Sacramento California, 95817, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

72

Study ID:

NCT02366806

Recruitment Status:

Completed

Sponsor:


University of California, Davis

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