Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Breast Carcinoma, Prognostic Stage 0 Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8
Conditions
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.
Interventions
OTHERCounseling
Undergo verbal counseling
OTHEREducational Intervention
View photo guide
BEHAVIORALQuestionnaire
Complete questionnaires
Sponsors
OHSU Knight Cancer Institute
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient reported anxiety and depression | Baseline to 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Cosmesis expectations versus self-reported experiences | Up to 12 months | Assessed through a custom survey. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCarl Post
OHSU Knight Cancer Institute
Outcome results
None listed