Effectiveness of CGA on QoL in Older Patients With Cancer Receiving Systemic Therapy
- Conditions
- Comprehensive Geriatric AssessmentGeriatrics
- Interventions
- Behavioral: CGA coordination by geriatric team including intensive patient coaching and follow-up
- Registration Number
- NCT04069962
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 204
-
patients aged 70 years and older
-
diagnosis of cancer (solid tumors)
-
starting systemic therapy (chemotherapy, immunotherapy, targeted therapy or hormonal therapy)
- curative intent (neo-adjuvant / adjuvant / concomitant / other)
- palliative intent (first line / second line)
-
patients must be able to comply with the study procedures
-
physician-estimated life expectancy must be more than 6 months
- patients with antihormonal monotherapy
- previous participation in geriatric intervention studies
- patients included in clinical trials with non-registered anticancer drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group CGA coordination by geriatric team including intensive patient coaching and follow-up Patients 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.
- Primary Outcome Measures
Name Time Method Quality of Life (QoL): EORTC QLQ-C30 QoL at 6 months since the start of the systemic therapy 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.
- Secondary Outcome Measures
Name Time Method Evolution in QoL: EORTC QLQ-C30 over 1 year follow up since the start of the systemic therapy 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.
Measurement of patient satisfaction: questionnaire over 1 year follow up since the start of the systemic therapy 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))
Evolution of functional status (FS) measured by Activities of Daily Living (ADL) over 1 year follow up since the start of the systemic therapy 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).
Evolution of functional status (FS) measured by Instrumental Activities of Daily Living (IADL) over 1 year follow up since the start of the systemic therapy 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).
Rate of falls at 3, 6 and 12 months since the start of systemic therapy Rate of falls measured by self-report of fall history
QoL: EORTC QLQ-C30 QoL at 3 and 12 months since the start of the systemic therapy 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.
Measurement of systemic therapy-related adverse events over 1 year follow up since the start of the systemic therapy 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
Measurement of geriatric recommendations at 3, 6 and 12 months since the start of systemic therapy Number of geriatric recommendations and adherence of geriatric recommendations (= geriatric interventions)
Measurement of actions undertaken at 3, 6 and 12 months since the start of systemic therapy 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.
Overall Survival over 2 year follow-up since the start of systemic therapy the length of time from the start of treatment and death from any cause
Number of patients with premature interruption of systemic therapy over 1 year follow up since the start of the systemic therapy Premature interruption of systemic therapy is defined as the complete discontinuation of the systemic therapy the patient receives in this study.
Trial Locations
- Locations (1)
UZ Gasthuisberg Leuven
🇧🇪Leuven, Belgium