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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02366806
• Other study ID #: 587842
• Secondary ID: CCRO035
• Status: Completed
• Start date: April 2014
• Est. completion date: April 7, 2017

Study information

• Verified date: October 2020
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 7, 2017
• Est. primary completion date: April 7, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	UC Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction measure	Questions on the survey will be analyzed to see if patients are more satisfied with the in-depth education compared to the standard education.	3 months
Secondary	Time measure	The amount of time in the clinic office will be analyzed for the in-depth education plan as compared to the standard education plan.	3 Months
Secondary	Change in satisfaction over time	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.	3 months