50 Randomized Clinical Trial 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 (COPE Study)

Background

Radiation therapy (RT) is a critical component of treatment for women with stage 0–IIIA breast cancer, yet initiating RT can be highly stressful, contributing to significant anxiety, depression, and uncertainty about expected adverse effects. Up to 40% of patients report moderate or marked changes in breast appearance years after RT, and psychological distress can further worsen patient-perceived cosmetic and treatment-related outcomes. Prior research demonstrates that education about RT expectations can reduce patient stress and improve coping; however, no standardized educational photo guide currently exists to visually depict common external RT adverse effects. This randomized clinical trial evaluates whether supplementing standard verbal counseling with a pictorial educational tool reduces psychological morbidity, specifically anxiety, depression, and treatment-related worries in women receiving adjuvant breast RT.

Materials and Methods

Eligible participants were English-speaking women aged 18 or older, diagnosed with stage 0 to IIIA breast cancer, scheduled for adjuvant whole-breast RT (hypofractionated or standard fractionated). Patients planned for ultra-hypofractionated RT, partial-breast RT, or concurrent radiosensitizing chemotherapy were excluded. Participants were randomized 1:1 using block randomization to either the experimental arm (standard verbal counseling plus a pictorial COPE photo guide) or the control arm (standard verbal counseling alone). A total of 68 patients were allocated evenly between the 2 groups (n = 34 per arm). Anxiety and depression were assessed using the NCI Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at baseline, during radiation therapy, and at 2-week and 6-month post-treatment follow-ups.

Results

Short-term results show that while patients who received the pictorial guide demonstrated modest trends toward lower anxiety frequency and greater confidence in understanding short- and long-term RT effects, these differences were not statistically significant in the current sample (Figure). The only statistically significant (Cochran-Armitage test P-value = .049) outcome was that patients who received the pictorial guide had better scores in relation to their post-treatment skin changes.

Conclusion

With a pictorial guide, women undergoing RT for their breast cancer perceived themselves to have more favorable skin changes compared with those with standard verbal counseling alone. Additionally, while differences between groups were not statistically significant (P >.05), modest trends favoring the pictorial guide suggest comprehensive education with a photo guide may reduce emotional morbidity and improve patient-perceived RT outcomes. Long-term follow-up, including the upcoming 6-month assessment, is ongoing and will determine whether these early trends develop into sustained psychological benefits.