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

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.

Inclusion Criteria

1. Diagnosis of invasive breast cancer

2. AJCC stage 1, 2, 3 breast carcinoma

3. Patient deemed clinically appropriate for adjuvant breast or chest wall radiation
following surgery

4. Women of childbearing potential must be non-pregnant and non-lactating and willing to
use medically acceptable form of contraception during radiation therapy

5. Patient must provide study specific informed consent prior to study entry

6. Breast implants allowed

Exclusion Criteria

1. Stage 4 breast cancer

2. Ductal carcinoma in situ

3. Patients treated with radiation for palliative intent

4. Prior treatment with radiation therapy to the ipsilateral breast or chest wall

5. 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

6. Prior invasive or in-situ carcinoma of the breast (-prior LCIS is eligible)

7. Diagnosis of DCIS