Trials / Active Not Recruiting

Active Not RecruitingNCT04993313

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

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

Status: Active Not Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 62 (actual)

Sponsor: OHSU Knight Cancer Institute · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
OTHER	Counseling	Undergo verbal counseling
OTHER	Educational Intervention	View photo guide
BEHAVIORAL	Questionnaire	Complete questionnaires

Timeline

Start date: 2022-03-18
Primary completion: 2027-02-28
Completion: 2027-02-28
First posted: 2021-08-06
Last updated: 2026-04-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04993313. Inclusion in this directory is not an endorsement.