Patient-reported results
Why patient-reported results?
Many men treated for prostate cancer experience side effects. Some patients experience side effects that are so bothersome that they affect their quality of life.
The aim of this pilot study was to find concrete measures to improve the quality of life for prostate cancer patients.
Results have been published in the annual report from the National Quality Registry for Prostate Cancer. In addition, articles are published in professional journals. The Movember Foundation funded the study, which monitored health status over several years.
Invitation, participation and consent
All men who were diagnosed with prostate cancer in the period 1 January 2017 to 31 December 2019 were invited to participate in the survey. A control group consisting of men with no history of prostate cancer was also invited to participate.
The invitations were sent electronically or by regular (paper) mail. It was possible to participate electronically, even if the invitation was received by regular mail.
The first invitation to participate in the survey was sent shortly after diagnosis, and the invitation for round two after one year. The invitation for round three were sent out after three years.
Participation in the study is voluntary. Consent to participate in the study may be withdrawn at any time. The consent can be withdrawn by accessing the https://minside.kreftregisteret.no, or by sending a letter (postal address at the bottom of the page). Withdrawal of consent means that all information collected in the survey is deleted from the project's database, and no more inquiries about this survey are received.
Participation in the study is voluntary. Consent to participate in the study may be withdrawn at any time. The consent can be withdrawn by accessing the https://minside.kreftregisteret.no, or by sending a letter (postal address at the bottom of the page). Withdrawal of consent means that all information collected in the survey will be deleted from the project's database. You will not receive any more inquiries about this survey.
The questionnaire
The questionnaire consisted of four main parts:
- Background
- General state of health
- Symptoms that may be typical for cancer patients
- Symptoms that occur to varying degrees in men who have, or are being treated for, prostate cancer
The purpose of the questions was to obtain the most comprehensive picture possible of the health status of the individual participant. The study contained general, cancer-specific and prostate cancer-specific questions in order to compare results from the group of prostate cancer patients with results for other cancers, other diseases and the control group.
Privacy
The study was approved by the Regional Committee for Medical and Health Research Ethics (ref.nr. 2015/1297/REC South-East C). The study has approval through 12/31/2028. Only specially authorised employees, who are subject to a duty of confidentiality and linked to the project, are able to identify individuals. It will not be possible to identify individuals in the results of the study when these are published.
Under the new Personal Data Act, The Norwegian Institute of Public Health and project manager Tom Børge Johannesen have an independent responsibility to ensure that the processing of your information has a legal basis. This project has a legal basis in Article 6 (1)(a) of the General Data Protection Regulation and Article 9 (2)(a).
Sharing of data and transfers abroad
By participating in the project, you also agree that information from the questionnaire may be transferred abroad as part of research collaboration and publication.
De-identified data may be disclosed to Monash University, Australia, for use in an international research project that seeks to improve the treatment and follow-up of prostate cancer through mapping patients' quality of life (The movember true north). These may be countries with laws that do not ensure European data protection laws. The project manager will ensure that your information is handled in a safe manner. The code that links you to your personally identifiable information will not be disclosed.
Disclosure of data to healthcare institutions
For participants who have been diagnosed with prostate cancer, participation in the survey means that the participants also agree that information from the questionnaire can be disclosed to the health institution (hospital/GP's office, etc.) that follows up the patient. Some health institutions will use the information to quality assure the treatment patients receive. Health institutions that request information from the questionnaire may only use this information for their own purposes if they have the necessary basis for processing (prior approval from REK, licence from the Norwegian Data Protection Authority or recommendation from a data protection officer).
