1. Health Status (Time Frame - 6 months): Using the EuroQol-visual analogue scale, abbreviated as EQ-VAS Scale, containing values between 100 (best imaginable health) and 0 (worst imaginable health), (answered by patients)
2. Complaints/Symptoms (Time Frame - 6 months): Assessed using a question set aligned with the PRO-CTCAE and CTCAE (answered by patients)
3. Presence or Absence of SAEs (Time Frame - 6 months): yes/no (answered by physician)
4. Presence or Absence of dosis reductions (Time Frame - 6 months): yes/no (answered by physician)
5. Presence or Absence of treatment interruptions (Time Frame - 6 months): yes/no (answered by physician)
6. Presence or Absence of disease progression (Time Frame - 6 months): yes/no (answered by physician)
7. Presence or Absence of disease regression (Time Frame - 6 months): yes/no (answered by physician)
8. Presence or Absence of death (Time Frame - 6 months): yes/no (answered by physician)
Secondary outcome:
1. Cancer type (Time Frame - 6 months): according to ICD classification
2. Patient Typology (Time Frame - 6 months): According to Bloem et al (PMID: 32771005)
3. Timepoints of patient documentation (Time Frame - 6 months): The timepoints at which a patient uses the CANKADO System to document patient-reported outcomes are retrieved from the system including date and time
4. Frequency of patient documentation (Time Frame - 6 months): The frequency at which a patient uses the CANKADO System to document patient-reported outcomes are calculated using the timepoints of patient documentation
CANKADO PRO-React Onco: CANKADO PRO-React Onco is approved as class I medical device within the European Union (registration number DE /CA59 /371/2020-R/Hd) and is compliant with the FDA classification for Mobile Medical Devices (2015) Appendix B. The purpose of CANKADO PRO-React Onco is to be an automated digital support for patients to help them decide how urgent it is to contact the attending physician based on the symptoms they independently record in the system. It supports patients with cancer under systemic, anti-tumor or anti-hormonal therapy in adjuvant, neoadjuvant, post-neoadjuvant or palliative situations. It is unsuitable for patients undergoing radiotherapy, cell and gene therapy, surgical procedures or alternative healing methods.
Quelle: ClinicalTrials.gov
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