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

Not Applicable

Recruiting

• Conditions: Prognostic Stage I Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Anatomic Stage 0 Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8
• Interventions: Other: Counseling; Behavioral: Questionnaire; Other: Educational Intervention

• Registration Number: NCT04993313
• Lead Sponsor: OHSU Knight Cancer Institute

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.

Study Timeline

• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-08-06
• Study Start: 2022-03-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (counseling)	Questionnaire	Patients undergo verbal counseling. Patients also complete questionnaires at 2 weeks, 6 and 12 months.
Arm I (counseling, photo guide)	Counseling	Patients undergo verbal counseling and view a photo guide. Patients also complete questionnaires at 2 weeks, 6 and 12 months.
Arm I (counseling, photo guide)	Educational Intervention	Patients undergo verbal counseling and view a photo guide. Patients also complete questionnaires at 2 weeks, 6 and 12 months.
Arm I (counseling, photo guide)	Questionnaire	Patients undergo verbal counseling and view a photo guide. Patients also complete questionnaires at 2 weeks, 6 and 12 months.
Arm II (counseling)	Counseling	Patients undergo verbal counseling. Patients also complete questionnaires at 2 weeks, 6 and 12 months.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Cosmesis expectations versus self-reported experiences	Up to 12 months	Assessed through a custom survey.

Trial Locations

Locations (1)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States