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
A Randomized Trial of Standard Verbal Counseling With or Without a Pictorial Educational Tool to Reduce Psychological Morbidity in Women Receiving Breast Radiation Therapy
2 other identifiers
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2021
CompletedFirst Posted
Study publicly available on registry
August 6, 2021
CompletedStudy Start
First participant enrolled
March 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
April 1, 2026
March 1, 2026
5 years
July 9, 2021
March 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Baseline to 12 months
Secondary Outcomes (1)
Cosmesis expectations versus self-reported experiences
Up to 12 months
Other Outcomes (1)
Accurate knowledge of radiation therapy side effects
Up to 12 months
Study Arms (2)
Arm I (counseling, photo guide)
EXPERIMENTALPatients undergo verbal counseling and view a photo guide. Patients also complete questionnaires at 2 weeks, 6 and 12 months.
Arm II (counseling)
ACTIVE COMPARATORPatients undergo verbal counseling. Patients also complete questionnaires at 2 weeks, 6 and 12 months.
Interventions
View photo guide
Undergo verbal counseling
Complete questionnaires
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OHSU Knight Cancer Institutelead
- Oregon Health and Science Universitycollaborator
Study Sites (1)
OHSU Knight Cancer Institute
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carl Post
OHSU Knight Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 9, 2021
First Posted
August 6, 2021
Study Start
March 18, 2022
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
February 28, 2027
Last Updated
April 1, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Immediately following publication. No end date.
- Access Criteria
- Proposals should be directed to xxx@yyy. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link: https://www.ohsu.edu/octri/redcap-your-complete-solution-online-databases-and-surveys-research)
All of the individual participant data collected during the trial, after deidentification, will be shared with anyone who wishes to access the data following a request proposal. Types of analyses included will be based on the approved proposal.