Standard Verbal Counseling With or Without a Pictorial Educational Tool for the Reduction of Psychological Morbidity in Patients With Stage 0-IIIA Breast Cancer Receiving Radiation Therapy, COPE Study
Primary Purpose
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counseling
Educational Intervention
Questionnaire
Sponsored by
About this trial
This is an interventional supportive care trial for Anatomic Stage 0 Breast Cancer AJCC v8
Eligibility Criteria
Inclusion Criteria:
- Breast cancer patients diagnosed with stage 0-IIIA disease who are planned to receive adjuvant hypofractionated or standard fractionated radiation treatment
- Patients must have the ability to read and understand English
Exclusion Criteria:
- Patients who are planned for ultra-hypofractionated radiation treatment
- Patients who are planned for partial breast radiation treatment
- Patients who are planned to receive concurrent radiosensitizing chemotherapy
Sites / Locations
- OHSU Knight Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm I (counseling, photo guide)
Arm II (counseling)
Arm Description
Patients undergo verbal counseling and view a photo guide. Patients also complete questionnaires at 2 weeks, 6 and 12 months.
Patients undergo verbal counseling. Patients also complete questionnaires at 2 weeks, 6 and 12 months.
Outcomes
Primary Outcome Measures
Change in patient reported anxiety and depression
Will use items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (CTCAE). Depression and anxiety will be analyzed as binary outcomes. Will compare questionnaire scores for anxiety and depression between the two groups. Scores will be reported as descriptive using CTCAE grading scale ranging from "mild" (1) to "life threatening" (4).
Secondary Outcome Measures
Cosmesis expectations versus self-reported experiences
Assessed through a custom survey.
Full Information
NCT ID
NCT04993313
First Posted
July 9, 2021
Last Updated
March 28, 2023
Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT04993313
Brief Title
Standard Verbal Counseling With or Without a Pictorial Educational Tool for the Reduction of Psychological Morbidity in Patients With Stage 0-IIIA Breast Cancer Receiving Radiation Therapy, COPE Study
Official Title
A Randomized Trial of Standard Verbal Counseling With or Without a Pictorial Educational Tool to Reduce Psychological Morbidity in Women Receiving Breast Radiation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science 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
This clinical trial studies the effect of standard verbal counseling with or without a pictorial educational tool for the reduction of psychological morbidity in patients with stage 0-IIIA breast cancer receiving radiation therapy. Beginning radiation therapy for breast cancer can be stressful. Education about what to expect often reduces the stress, anxiety, and depression experienced by these patients. This study is being done to see how effective photos are in reducing stress, anxiety, and depression associated with radiation therapy for patients with breast cancer.
Detailed Description
PRIMARY OBJECTIVE:
I. Assessment of patient reported anxiety and depression, confidence with information, and side effect expectations of radiation therapy following counseling with or without photo guide at pre-treatment, 2 weeks, 6 months, and 12 months.
SECONDARY OBJECTIVE:
I. Efficacy of intervention to impart reasonable expectations of the side effect burden of radiation therapy (RT).
EXPLORATORY OBJECTIVE:
I. Picture Guide book.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo verbal counseling and view a photo guide. Patients also complete questionnaires at 2 weeks, 6 and 12 months.
ARM II: Patients undergo verbal counseling. Patients also complete questionnaires at 2 weeks, 6 and 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage 0 Breast Cancer AJCC v8, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Breast Carcinoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I (counseling, photo guide)
Arm Type
Experimental
Arm Description
Patients undergo verbal counseling and view a photo guide. Patients also complete questionnaires at 2 weeks, 6 and 12 months.
Arm Title
Arm II (counseling)
Arm Type
Active Comparator
Arm Description
Patients undergo verbal counseling. Patients also complete questionnaires at 2 weeks, 6 and 12 months.
Intervention Type
Other
Intervention Name(s)
Counseling
Other Intervention Name(s)
Counseling Intervention
Intervention Description
Undergo verbal counseling
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
View photo guide
Intervention Type
Behavioral
Intervention Name(s)
Questionnaire
Other Intervention Name(s)
Questionnaires
Intervention Description
Complete questionnaires
Primary Outcome Measure Information:
Title
Change in patient reported anxiety and depression
Description
Will use items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (CTCAE). Depression and anxiety will be analyzed as binary outcomes. Will compare questionnaire scores for anxiety and depression between the two groups. Scores will be reported as descriptive using CTCAE grading scale ranging from "mild" (1) to "life threatening" (4).
Time Frame
Baseline to 12 months
Secondary Outcome Measure Information:
Title
Cosmesis expectations versus self-reported experiences
Description
Assessed through a custom survey.
Time Frame
Up to 12 months
Other Pre-specified Outcome Measures:
Title
Accurate knowledge of radiation therapy side effects
Description
Assessed through a custom survey. This will be assessed using a custom questionnaire that assesses the patient's perception of their own understanding of radiation-related side effects.
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Breast cancer patients diagnosed with stage 0-IIIA disease who are planned to receive adjuvant hypofractionated or standard fractionated radiation treatment
Patients must have the ability to read and understand English
Exclusion Criteria:
Patients who are planned for ultra-hypofractionated radiation treatment
Patients who are planned for partial breast radiation treatment
Patients who are planned to receive concurrent radiosensitizing chemotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl Post
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl Post
Phone
503-494-8652
Email
postc@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Carl Post
12. IPD Sharing Statement
Learn more about this trial
Standard Verbal Counseling With or Without a Pictorial Educational Tool for the Reduction of Psychological Morbidity in Patients With Stage 0-IIIA Breast Cancer Receiving Radiation Therapy, COPE Study
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