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

NCT02366806 | Completed

• 2 other identifiers: 587842CCRO035
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; AJCC Stage 1, 2, 3; Educational Design; Radiation Therapy Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time measure

  3 Months

• Change in satisfaction over time

  3 months

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosis of invasive breast cancer
• AJCC stage 1, 2, 3 breast carcinoma
• Patient deemed clinically appropriate for adjuvant breast or chest wall radiation following surgery
• Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
• Patient must provide study specific informed consent prior to study entry
• Breast implants allowed

You may not qualify if:

• Stage 4 breast cancer
• Ductal carcinoma in situ
• Patients treated with radiation for palliative intent
• Prior treatment with radiation therapy to the ipsilateral breast or chest wall
• 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
• Prior invasive or in-situ carcinoma of the breast (-prior LCIS is eligible)
• Diagnosis of DCIS

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Megan Daly, MD

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: February 19, 2015
• Study Start: April 1, 2014
• Primary Completion: April 7, 2017
• Study Completion: April 7, 2017
• Last Updated: October 28, 2020

Record last verified: 2020-10

Locations

US (1)