Clinical trial NCT02366806: Impact of Individualized Radiotherapy Plan Review in Patients Receiving Adjuvant Radiotherapy for Breast Cancer
Official title: Impact of Individualized Radiotherapy Plan Review in Patients Receiving Adjuvant Radiotherapy for Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer
AJCC Stage 1, 2, 3
Educational Design
Radiation Therapy Treatment
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2015-02-19
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study is for women with breast cancer. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Satisfaction measure
timeFrame: 3 months
Secondary outcomes:
measure: Time measure
timeFrame: 3 Months
measure: Change in satisfaction over time
timeFrame: 3 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: UC Davis
name: Megan Daly, MD
role: PRINCIPAL_INVESTIGATOR
References: