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A Randomized Trial of Standard Verbal Counseling With or Without a Pictorial Educational Tool to Reduce Psychological Morbidity in Women Receiving Breast Radiation Therapy
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
OHSU Knight Cancer Institute
Portland, Oregon, United States
Start Date
March 18, 2022
Primary Completion Date
February 28, 2026
Completion Date
February 28, 2026
Last Updated
June 12, 2025
62
ACTUAL participants
Counseling
OTHER
Educational Intervention
OTHER
Questionnaire
BEHAVIORAL
Lead Sponsor
OHSU Knight Cancer Institute
Collaborators
NCT06401889
NCT06324240
Data Source & Attribution
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