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

NCT04993313 — Not applicable, Active not recruiting, 62 participants, OHSU Knight Cancer Institute

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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

Registry	NCT04993313
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	62 (Actual)
Sponsor	OHSU Knight Cancer Institute (Other); collaborators: Oregon Health and Science University
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, 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, Breast Carcinoma
Interventions	Counseling, Educational Intervention, Questionnaire (Other, behavioral)
Dates	start 2022-03-18, primary completion 2027-02-28 (estimated), completion 2027-02-28 (estimated), first posted 2021-08-06, last updated 2026-09-15
Locations	1 site in United States

-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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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Arm I (counseling, photo guide)	Experimental	Other: Counseling; Other: Educational Intervention; Behavioral: Questionnaire	Patients undergo verbal counseling and view a photo guide. Patients also complete questionnaires at 2 weeks, 6 and 12 months.
Arm II (counseling)	Active comparator	Other: Counseling; Behavioral: Questionnaire	Patients undergo verbal counseling. Patients also complete questionnaires at 2 weeks, 6 and 12 months.

Counseling (Other), also known as Counseling Intervention: Undergo verbal counseling
Educational Intervention (Other), also known as Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational: View photo guide
Questionnaire (Behavioral), also known as Questionnaires: Complete questionnaires

+Outcome measures

Primary outcomes

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 outcomes

Cosmesis expectations versus self-reported experiences [Up to 12 months]: Assessed through a custom survey.

Other outcomes

Accurate knowledge of radiation therapy side effects [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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
OHSU Knight Cancer Institute	Portland, Oregon	United States

+Investigators

Carl Post, Principal investigator, OHSU Knight Cancer Institute