Plans for assessment and collection of outcomes {18a}
nausea, loss of appetite, dyspnea, fatigue, Pain, ASIA, cancer pain, sleeping difficulties, constipation, pain, neurological deterioration, Toxicity, Cancer
ADVERSE EVENT, SPINAL CORD, CANCER
According to the TwiCs design, demographic and clinical data and regular PROMs collected in the PRESENT cohort will be used for effect estimation. In general, patients fill out the EORTC QLQ-C15-PAL, the EORTC QLQ-BM22, the EuroQol (EQ) 5D-5L, and the BPI at baseline (upon cohort enrolment, i.e., before the start of treatment), 4 and 8 weeks, 3 and 6 months after initial treatment, and every 6 months thereafter. At 2 and 6 weeks, patients fill out an additional BPI [The primary outcome is physical functioning at 4 weeks that will be assessed using the EORTC QLQ-C15-PAL, a 15-item HRQOL questionnaire representing overall QOL, two functional scales (physical and emotional functioning), and six symptom scales (nausea, loss of appetite, dyspnea, constipation, sleeping difficulties, and fatigue) [The duration of pain relief up to three months will be measured by the BPI which is a multidimensional tool to evaluate cancer pain [Pain response at 2, 4, 6, and 8 weeks and 3 months is defined as [Information on duration of the hospital stay in days, days until return to systemic oncological therapy, local control, and progression free survival and overall survival will be captured from the electronic health record. Also, occurrence of neurological deterioration, defined as deterioration of more than one grade on the American Spinal Cord Injury Association (ASIA) scale as measured by physical examination by a neurologists or trained ASIA physician, will be captured from the electronic health record [AEs are defined as any undesirable experience occurring to a patient during the study that may be related to the experimental treatment procedure. AEs during hospital stay will be evaluated using the most recent version of the National Cancer Institute Common Toxicity Criteria of Adverse Events (CTCAE; version 5.0, version 6.0 when available at the start of the study). AEs after hospital discharge reported spontaneously by the patient or observed by the research team will be recorded up to 3 months after treatment.For cost-effectiveness evaluation, resource use, costs, and quality-adjusted life years (QALYs) are measured for each patient in both randomization groups over the follow-up period. Resource use such as doctor visits, medication, hospital admissions, and surgical interventions, as well as out-of-pocket expenses such as for over-the-counter drugs and travel costs, will be captured using the iMCQ at 3 and 6 months [