Purpose This study aimed to assess cancer patients’ knowledge and perceptions regarding fatigue and to provide up-to-date information on the current fatigue management from the patients’ perspective. Methods The FiX study recruited 2508 cancer patients approximately 2 years after diagnosis via a cancer registry in Germany. Participants completed a questionnaire on their knowledge and perceptions of fatigue and the management received. Results More than half of respondents (58%), especially among the elderly patients, did not feel well informed about fatigue. Overall, 41% reported having never been asked about being exhausted by their treating physician. Even fewer patients stated that general practitioners or nurses have asked if they felt exhausted. Only 13% of patients who had experienced severe fatigue had received a fatigue assessment by means of a rating scale or questionnaire—although this is recommended by existing guidelines for fatigue screening. Health care professionals seemed less likely to address fatigue with elderly as well as female patients. The most commonly reported measure against fatigue was exercise or regular physical activity (68%). However, this was mostly done on patients’ own initiative. Psychological support was rarely used (13%) and only in approximately half of the cases upon the advice of a physician. Yoga, another promising intervention against fatigue, was performed by only 9% of patients. Conclusions Our study indicates deficits in terms of knowledge, education, screening, counseling, and treatment for fatigue and highlights starting points for targeted improvements in fatigue management based on patients’ needs.

Background Secondary use of clinical data for biomedical research purposes holds great potential for various types of noninterventional, data-driven studies. Patients’ willingness to support research with their clinical data is a crucial prerequisite for research progress. Objective The aim of the study was to learn about patients’ attitudes and expectations regarding secondary use of their clinical data. In a next step, our results can inform the development of an appropriate governance framework for secondary use of clinical data for research purposes. Methods A questionnaire was developed to assess the willingness of patients with cancer to provide their clinical data for biomedical research purposes, considering different conditions of data sharing and consent models. The Cancer Registry of the German federal state of Baden-Württemberg recruited a proportionally stratified random sample of patients with cancer and survivors of cancer based on a full census. Results In total, 838 participants completed the survey. Approximately all participants (810/838, 96.7%) showed general willingness to make clinical data available for biomedical research purposes; however, they expected certain requirements to be met, such as comparable data protection standards for data use abroad and the possibility to renew consent at regular time intervals. Most participants (620/838, 73.9%) supported data use also by researchers in commercial companies. More than half of the participants (503/838, 60%) were willing to give up control over clinical data in favor of research benefits. Most participants expressed acceptance of the broad consent model (494/838, 58.9%), followed by data use by default (with the option to opt out at any time; 419/838, 50%); specific consent for every study showed the lowest acceptance rate (327/838, 39%). Patients expected physicians to share their data (763/838, 91.1%) and their fellow patients to support secondary use with their clinical data (679/838, 81%). Conclusions Although patients’ general willingness to make their clinical data available for biomedical research purposes is very high, the willingness of a substantial proportion of patients depends on additional requirements. Taking these perspectives into account is essential for designing trustworthy governance of clinical data reuse and sharing. The willingness to accept the loss of control over clinical data to enhance the benefits of research should be given special consideration.

BACKGROUND Secondary use of clinical data for biomedical research purposes holds great potential for various types of non-interventional, data-driven studies. Patients’ willingness to support research with their clinical data is a crucial prerequisite for research progress. OBJECTIVE The aim of the study is to learn about patients’ attitudes and expectations regarding secondary use of their clinical data in order to inform the development of an appropriate governance framework for secondary use of clinical data for research purposes. METHODS A questionnaire was developed to assess willingness of cancer patients to provide their clinical data for biomedical research purposes considering different conditions of data sharing and consent models. The Cancer Registry of the German federal state of Baden-Württemberg recruited a proportionally stratified random sample of cancer patients/survivors based on a full census. RESULTS 838 participants completed the survey. Nearly all participants showed general willingness to make clinical data available for biomedical research purposes (97%); however, they expected certain requirements to be met such as comparable data protection standards for data use abroad and the possibility to renew consent at regular time intervals. The majority supported data use also by researchers in commercial companies (74%). More than half of the participants were willing to give up control over clinical data in favour of research benefits (60%). The majority expressed acceptance of the Broad Consent model (59%), followed by the Opt-Out model (50%); specific consent for every study showed the lowest acceptance rate (39%). Patients expected physicians to share their data (91%), and expected their fellow patients to support secondary use with their clinical data (81%). CONCLUSIONS While patients’ general willingness to make their clinical data available for biomedical research purposes is very high, the willingness of a substantial proportion of patients depends on additional requirements. Taking these perspectives into account is essential for designing trustworthy governance of clinical data re-use and sharing. The willingness to accept loss of control over clinical data in order to enhance the benefits of research should be given special consideration.

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