Update
Introduction
Trial overview
The primary outcome and sample size
Secondary outcomes and power
Exploratory outcomes
Descriptive variables
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 |
Plan of statistical analysis
Significance levels
Analysis of the primary outcome
Sensitivity and explorative analyses of the primary outcome
Imputations | Adjusted | Area under the curve (AUC) | Intention-to-treat (ITT) principle | |
---|---|---|---|---|
Fully adjusted analysis
| Yes, as in the primary analysis | Adjusted for covariates (center, WHO performance status, time since the patient was diagnosed with metastases, treatment status, sex, age, diagnosis and education) that are associated with the primary outcome (P <0.10 in a univariate test) and where missing <5% | Yes, as in the primary analysis | Modified ITT analysis as in the primary analysis. |
Complete case analysis
| No | Yes, as in the primary analysis | Yes, as in the primary analysis | Violated, no imputations for patients who did not respond to the questionnaire. Analysis may be biased |
Model for repeated measurement analysis
| Yes, as in the primary analysis | Yes, as in the primary analysis | No. The three- and eight-week follow-ups are assessed individually | Modified ITT analysis as in the primary analysis |
Per protocol analysis
| Yes, as in the primary analysis | Yes, as in the primary analysis | Yes, as in the primary analysis | Violated, excluding patients who did not receive the experimental intervention (defined as at least one contact to the SPC team). The analysis thus only describes the effect of the intervention on those complying with the intervention, which is a subgroup of patients
|
Including patients who died
| Yes, as in the primary analysis | Yes, as in the primary analysis | Yes, as in the primary analysis | ITT analysis. Multiple imputations for patients who do not respond or die |