From: Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT)
Variable | Definition | Assessed by/assessed from |
---|---|---|
Baseline variables | ||
Sex | The Danish Civil Registration System (called CPR in Danish) which depict sex and age | |
Age | The Danish Civil Registration System (called CPR in Danish) which depict sex and age | |
Cancer | Project nurse | |
Receiving treatment (yes/no) | Whether the patient is receiving active anti-neoplastic treatment at the time of randomization | Project nurse |
Education | Questionnaire, self-assessment | |
WHO performance score | Project nurse | |
Time since diagnosed with cancer stage four | Assessment based on the TNM (tumor, node, metastasis) system. First time it is documented that the patient has stage four cancer. Staging is updated, so a patient diagnosed with stage two and developing distant metastases at a later time is considered as having stage four when the metastases are discovered | Doctors or students with at least a bachelor degree in medicine |
Time since diagnosed with primary cancer | Project nurse | |
Study descriptive variables | ||
Center | There are six centers included in the study | |
Primary need | Each patient is randomized for one out of seven potential primary needs (please see article text) | Questionnaire, self-assessment |
Use of health care services outside the hospital | Use of for example, psychologist, physiotherapist or other health care services outside the hospital in the eight-week intervention period | Questionnaire, self-assessment |
Cross-over | Patients from the control group receiving at least one physical contact with specialized palliative care (SPC) within the study period | Students |
Protocol violations | Patients from the intervention group not receiving at least one physical contact with the SPC within the study period | Students |