Impact of Individualized Radiotherapy Plan Review in Patients Receiving Adjuvant Radiotherapy for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02366806|
Recruitment Status : Recruiting
First Posted : February 19, 2015
Last Update Posted : May 8, 2018
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Impact of Individualized Radiotherapy Plan Review in Patients Receiving Adjuvant Radiotherapy for Breast Cancer|
|Actual Study Start Date :||April 2014|
|Estimated Primary Completion Date :||February 2027|
|Estimated Study Completion Date :||February 2027|
A. Standard radiotherapy discussion including rationale, number of fractions, side effects, +/- beam arrangements, potential and likely short and long-term toxicity, status checks, skin care, nursing and physician accessibility B. Radiotherapy plan review to include, but not limited to: beam arrangement, total dose, dose per fraction, target area(s), description of isodose lines, DVH review and discussion of prescription constraints for OARs
- Satisfaction measure [ Time Frame: 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.
- Time measure [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02366806
|Contact: Jyoti Mayadev, MDfirstname.lastname@example.org|
|Contact: Megan Daly, MDemail@example.com|
|United States, California|
|UC Davis Medical Center||Recruiting|
|Sacramento, California, United States, 95817|
|Principal Investigator: Jyoti Mayadev, MD|
|Sub-Investigator: Megan Daly, MD|
|Principal Investigator:||Jyoti Mayadev, MD||UC Davis|