Abstract

Introduction: The pathophysiology for cognitive impairment is observed both in healthy women having false-positive mammography screening results and as a side-effect of breast cancer treatment. This randomized controlled pilot trial, a sub-study of Onk-kong trial aimed to compare the feasibility and acceptability of CRT versus standard of care on patients with an objective cognitive impairment in association with false-positive screening results as well as breast cancer treatment.

Method: Women with false-positive screening results or breast cancer completed the Headminder Web-based neuropsychological battery Cognitive Stability Index for response speed, processing speed, memory, and attention before diagnosis, 9 months after diagnosis (T1), and after another 3 months of follow-up (T2). A total of 31 women with an objective cognitive impairment at T1 were prospectively enrolled and randomized between training programs and expectancy. A modified psychological training program developed for schizophrenic patients, Cognitive Remediation Therapy was used and tested, by trained nurses.

Result: In total 14 women were randomized to Cognitive Remediation Therapy and 17 to expectancy. Of the randomized women, 12 fulfilled the criteria for inclusion in this study. Of these 12 women, 6 attended and fulfilled Cognitive Remediation Therapy. Five declined participation in the program, because of not having time, one couldn’t start due to lack of available trainer. At T2 the results showed no improvement in any group. The dependence of the clinical setting caused problem.

Conclusion: Our study design did not enable us to demonstrate the feasibility and acceptability of the modified CRT-program among women with a breast cancer diagnosis as well as false-positive screening results or breast cancer. The study has identified several logistical issues. Changes need to be made in the conduct of the CRT to be useful also for breast cancer patients