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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
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease
Breast Cancer

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.


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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort
In-Depth Education
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Jyoti Mayadev, MD 916-724-8269 jyoti.mayadev@ucdmc.ucdavis.edu
Contact: Megan Daly, MD 916-724-5428 megan.daly@ucdmc.ucdavis.edu

Locations
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United States, California
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Principal Investigator: Jyoti Mayadev, MD         
Sub-Investigator: Megan Daly, MD         
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Jyoti Mayadev, MD UC Davis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02366806     History of Changes
Other Study ID Numbers: 587842
CCRO035 ( Other Identifier: UC Davis )
First Posted: February 19, 2015    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

Keywords provided by University of California, Davis:
Breast Cancer
AJCC Stage 1, 2, 3
Educational Design
Radiation Therapy Treatment

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases