Breast Cancer Clinical 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

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.

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Full 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.

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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

Study is for people with:

Breast Cancer

Estimated Enrollment:

60

Study ID:

NCT04993313

Recruitment Status:

Recruiting

Sponsor:

OHSU Knight Cancer Institute

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There is 1 Location for this study

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OHSU Knight Cancer Institute
Portland Oregon, 97239, United States More Info
Kiri A. Cook
Contact
503-494-8756
[email protected]
Kiri A. Cook
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

60

Study ID:

NCT04993313

Recruitment Status:

Recruiting

Sponsor:


OHSU Knight Cancer Institute

How clear is this clinincal trial information?

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