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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-06325 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00020501 | Other Identifier | OHSU Knight Cancer Institute |
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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (counseling, photo guide) | Experimental | Patients undergo verbal counseling and view a photo guide. Patients also complete questionnaires at 2 weeks, 6 and 12 months. |
|
| Arm II (counseling) | Active Comparator | Patients undergo verbal counseling. Patients also complete questionnaires at 2 weeks, 6 and 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counseling | Other | Undergo verbal counseling |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmesis expectations versus self-reported experiences | Assessed through a custom survey. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Accurate knowledge of radiation therapy side effects | 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. | Up to 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl Post | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
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.
Immediately following publication. No end date.
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)
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| Educational Intervention | Other | View photo guide |
|
|
| Questionnaire | Behavioral | Complete questionnaires |
|
|
| ID | Term |
|---|---|
| D000071960 | Breast Carcinoma In Situ |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D002662 | Child Health Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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