Learning from patient involvement in a clinical study analyzing PET/CT in women with advanced breast cancer

Background Despite increasing interest in patient involvement in health care research, researchers may be uncertain about the benefits of involving patients in the design and conduction of clinical studies. We aimed to evaluate the impact of patient involvement on patient recruitment and retention in a clinical study of PET/CT in women with advanced breast cancer. Further, we report our experience regarding the researchers’ attitudes towards involving patients as partners in the research process. Methods Two patient representatives from the Danish Breast Cancer Organization were invited as partners in the research team. These patient partners were asked to contribute in particular to participator information material and evaluation of ethical aspects of the study. The impact of patient involvement on patient recruitment was evaluated by comparing expected versus actual number of patients recruited, and then relating it to patient recruitment in a similar study at the same institution that did not involve patients as research partners. Results Having patients as partners in the research team led to a major revision of the participator information material and improved patient recruitment. The expected number of patients was 260, but 380 were actually enrolled within the planned study period, thus 146% of the expected patient recruitment. In the previous study, only 100 of the expected 150 patients were enrolled during a 10-month extended study period, i.e. 67% of the expected number. Patient retention in the current study was high, with 86% of eligible patients attending follow-up scans. We observed initial resistance amongst researchers against inviting patients as team partners. This resistance gradually lessened during the study, and the most reluctant researchers at the beginning of the study later applauded the collaboration and the ideas generated by the patient representatives. Conclusion Involving patients as partners in the research team resulted in major changes to the participator information material and contributed to higher than expected patient recruitment and retention. Furthermore, we observed a positive change of attitude amongst the researchers towards patient involvement in the research process. Trial registration Ongoing study: ClinicalTrials.gov (NCT03358589). Previous study: ClinicalTrials.gov (NCT01552655).