Back to resultsAnalysis of Patient Understanding of Radiation Therapy Among Patients With Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Survey questionnaire
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients 18 years or older with non-invasive or invasive breast cancer receiving consultation at the breast radiation oncology clinic for radiotherapy recommendations
Exclusion Criteria:
- Patients under 18 years old or receiving palliative care
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients Who are Anticipated to Receive Definitive Treatment
Arm Description
Outcomes
Primary Outcome Measures
post-consultation telephone questionnaire
assess patient understanding and use of visual aids specifically in radiation oncology consultations
Secondary Outcome Measures
correlations between patient survey score as a measure of patient understanding
Patients will also be asked to rate the ease of understanding of visual aids provided and their utility in facilitating patient understanding of radiation oncology concepts. It will be analyzed via ANOVA to investigate the association of various factors to the patient's total score. Each participant's interview will be scored based on the following scoring system: Correct"=1point; "Incorrect" = 0 point.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05114525
Brief Title
Analysis of Patient Understanding of Radiation Therapy Among Patients With Breast Cancer
Official Title
Analysis of Patient Understanding of Radiation Therapy Among Patients With Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
October 12, 2021 (Actual)
Study Completion Date
October 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to conduct a descriptive feasibility study of assessing how patients retain and understand information regarding radiation therapy obtained from an initial consult visit. This study will also pilot the use of visual aids and assess their utility to patients during a consult. The study will provide a baseline to conduct larger studies that will later incorporate additional patient education tools to assess changes in patient understanding of information received in radiation oncology patient consultations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients Who are Anticipated to Receive Definitive Treatment
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Survey questionnaire
Intervention Description
The survey questionnaire will include semi-structured questions about patient demographics and patient understanding of the risks and benefits of radiation, different treatment options, the treatment process, utility of visual aid presentation and information gathering preference using a semi-structured questionnaire
Primary Outcome Measure Information:
Title
post-consultation telephone questionnaire
Description
assess patient understanding and use of visual aids specifically in radiation oncology consultations
Time Frame
10 days
Secondary Outcome Measure Information:
Title
correlations between patient survey score as a measure of patient understanding
Description
Patients will also be asked to rate the ease of understanding of visual aids provided and their utility in facilitating patient understanding of radiation oncology concepts. It will be analyzed via ANOVA to investigate the association of various factors to the patient's total score. Each participant's interview will be scored based on the following scoring system: Correct"=1point; "Incorrect" = 0 point.
Time Frame
10 days following consultation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients 18 years or older with non-invasive or invasive breast cancer receiving consultation at the breast radiation oncology clinic for radiotherapy recommendations
Exclusion Criteria:
Patients under 18 years old or receiving palliative care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Horst
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Analysis of Patient Understanding of Radiation Therapy Among Patients With Breast Cancer
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