The G-oncoCOACH study aims to evaluate the effectiveness of the Comprehensive Geriatric Assessment (CGA) process coordinated by a geriatric team in combination with intensive patient coaching compared to the current standard of care, which is CGA coordinated by an oncology team.
The G-oncoCOACH study aims to evaluate the effectiveness of the Comprehensive Geriatric Assessment (CGA) process coordinated by a geriatric team in combination with intensive patient coaching compared to the current standard of care, which is CGA coordinated by an oncology team. The Medical Research Council (MRC) Framework, developed to test complex interventions, is used to design this study. A multicenter randomized controlled trial will be conducted in two academic hospitals (UZ Brussel - UZ Leuven) with a follow-up at 3, 6 and 12 months after the start of systemic therapy. Patients will be recruited in both academic hospitals in the period between the cancer diagnosis and the start of the systemic therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
204
In the intervention group, the CGA including geriatric recommendations for interventions will be coordinated by the geriatric team and will be complemented with patient coaching. This intervention aims to support patient empowerment by improving self-efficacy and supporting self-management of existing age-related problems before systemic therapy or occurring during systemic therapy, and includes an individual counselling session at start of systemic therapy to discuss the recommendations with the patient and to determine their priorities.
UZ Gasthuisberg Leuven
Leuven, Belgium
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.
Time frame: QoL at 6 months since the start of the systemic therapy
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.
Time frame: QoL at 3 and 12 months since the start of the systemic therapy
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.
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Time frame: over 1 year follow up since the start of the systemic therapy
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))
Time frame: over 1 year follow up since the start of the systemic therapy
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).
Time frame: over 1 year follow up since the start of the systemic therapy
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).
Time frame: over 1 year follow up since the start of the systemic therapy
Rate of falls
Rate of falls measured by self-report of fall history
Time frame: at 3, 6 and 12 months since the start of systemic therapy
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
Time frame: over 1 year follow up since the start of the systemic therapy
Measurement of geriatric recommendations
Number of geriatric recommendations and adherence of geriatric recommendations (= geriatric interventions)
Time frame: at 3, 6 and 12 months since the start of systemic therapy
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.
Time frame: at 3, 6 and 12 months since the start of systemic therapy
Overall Survival
the length of time from the start of treatment and death from any cause
Time frame: over 2 year follow-up since the start of systemic therapy
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.
Time frame: over 1 year follow up since the start of the systemic therapy