Breast Cancer
Conditions
Keywords
Breast Cancer, AJCC Stage 1, 2, 3, Educational Design, Radiation Therapy Treatment
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.
Interventions
None listed
Sponsors
University of California, Davis
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed