Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Quality of Life (QoL): EORTC QLQ-C30 |
QoL measured by the EORTC Qlq - C30. HRQOL evaluation was performed using the European Organization for Research and Treatment Quality of Life Questionnaire core 30 (EORTC QLQ-C30) Global Health Status Scale (GHS). The two general questions 29 and 30 are selected: "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?". Patients answer these two questions by means of seven-point Likert scales and the two scores are combined to define the GHS. The GHS score is linearly transformed to a 0-100 score to facilitate statistical interpretation. A higher HRQOL is reported by a higher GHS score. |
QoL at 6 months since the start of the systemic therapy |
|
Secondary |
QoL: EORTC QLQ-C30 |
QoL measured by the EORTC Qlq - C30. HRQOL evaluation was performed using the European Organization for Research and Treatment Quality of Life Questionnaire core 30 (EORTC QLQ-C30) Global Health Status Scale (GHS). The two general questions 29 and 30 are selected: "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?". Patients answer these two questions by means of seven-point Likert scales and the two scores are combined to define the GHS. The GHS score is linearly transformed to a 0-100 score to facilitate statistical interpretation. A higher HRQOL is reported by a higher GHS score. |
QoL at 3 and 12 months since the start of the systemic therapy |
|
Secondary |
Evolution in QoL: EORTC QLQ-C30 |
QoL measured by the EORTC Qlq - C30. HRQOL evaluation was performed using the European Organization for Research and Treatment Quality of Life Questionnaire core 30 (EORTC QLQ-C30) Global Health Status Scale (GHS). The two general questions 29 and 30 are selected: "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?". Patients answer these two questions by means of seven-point Likert scales and the two scores are combined to define the GHS. The GHS score is linearly transformed to a 0-100 score to facilitate statistical interpretation. A higher HRQOL is reported by a higher GHS score. |
over 1 year follow up since the start of the systemic therapy |
|
Secondary |
Measurement of patient satisfaction: questionnaire |
Self-constructed questionnaire on patient satisfaction measuring the satisfaction of the patient with the care that has been received since the start of the systemic treatment (using a 5-point Likert scale; range 1 (not satisfied at all) -5 (very satisfied)) |
over 1 year follow up since the start of the systemic therapy |
|
Secondary |
Evolution of functional status (FS) measured by Activities of Daily Living (ADL) |
FS measured by Activities of Daily Living (ADL). The ADL scale includes six items (bathing, dressing, toileting, transferring, continence and feeding), with a score for each item scores ranging from one (able to perform the activity) to four (unable to perform the activity) (range: 6-24). |
over 1 year follow up since the start of the systemic therapy |
|
Secondary |
Evolution of functional status (FS) measured by Instrumental Activities of Daily Living (IADL) |
FS measured by Instrumental Activities of Daily Living (IADL). The Lawton scale includes eight items (ability to use the telephone, shopping, cooking, housekeeping, doing laundry, taking own medication, making transports and ability to handle finances), with a score for each item of zero (low function, dependent) or one (high function, independent). Because some of these items (cooking, housekeeping and doing laundry) are only fully applicable in women, these three items were not assessed in males in the original form, so the total score in men ranged from zero to five (range women: 0-8; range men: 0-5). |
over 1 year follow up since the start of the systemic therapy |
|
Secondary |
Rate of falls |
Rate of falls measured by self-report of fall history |
at 3, 6 and 12 months since the start of systemic therapy |
|
Secondary |
Measurement of systemic therapy-related adverse events |
Measurement of systemic therapy-related adverse events based on the NCI Common Terminology Criteria for Adverse Events, NCI CTCAE, version 5.0, grade 3 - 4 |
over 1 year follow up since the start of the systemic therapy |
|
Secondary |
Measurement of geriatric recommendations |
Number of geriatric recommendations and adherence of geriatric recommendations (= geriatric interventions) |
at 3, 6 and 12 months since the start of systemic therapy |
|
Secondary |
Measurement of actions undertaken |
Number of actions undertaken within the geriatric interventions and adherence to actions undertaken (= patient compliance) defined as the degree to which a patient correctly follows the actions undertaken within the geriatric interventions. |
at 3, 6 and 12 months since the start of systemic therapy |
|
Secondary |
Overall Survival |
the length of time from the start of treatment and death from any cause |
over 2 year follow-up since the start of systemic therapy |
|
Secondary |
Number of patients with premature interruption of systemic therapy |
Premature interruption of systemic therapy is defined as the complete discontinuation of the systemic therapy the patient receives in this study. |
over 1 year follow up since the start of the systemic therapy |
|