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NCT Number: NCT04993313

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8 Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8 Anatomic Stage IIB Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Breast Carcinoma Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prognostic Stage 0 Breast Cancer AJCC v8 Prognostic Stage I Breast Cancer AJCC v8 Prognostic Stage IA Breast Cancer AJCC v8 Prognostic Stage IB Breast Cancer AJCC v8 Prognostic Stage II Breast Cancer AJCC v8 Prognostic Stage IIA Breast Cancer AJCC v8 Prognostic Stage IIB Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling

Other

Undergo verbal counseling

Other names: Counseling Intervention

Educational Intervention

Other

View photo guide

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Questionnaire

Behavioral

Complete questionnaires

Other names: Questionnaires

Primary outcomes

  1. Change in patient reported anxiety and depression

    Time frame: 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 outcomes

  1. Cosmesis expectations versus self-reported experiences

    Time frame: Up to 12 months

    Assessed through a custom survey.

Other outcomes

  1. Accurate knowledge of radiation therapy side effects

    Time frame: Up to 12 months

    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.

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • Oregon Health and Science University

Registry information

Official study title

A Randomized Trial of Standard Verbal Counseling With or Without a Pictorial Educational Tool to Reduce Psychological Morbidity in Women Receiving Breast Radiation Therapy

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2021
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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