The Effectiveness of Patient Coaching Within the Comprehensive Geriatric Assessment Process on Quality of Life in Older Patients With Cancer Receiving Systemic Therapy: a Multicenter Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Geriatrics
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Enrollment
- 204
- Locations
- 1
- Primary Endpoint
- Quality of Life (QoL): EORTC QLQ-C30
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
prof. dr. Hans Wildiers
Principal Investigator
Universitaire Ziekenhuizen KU Leuven
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •patients with antihormonal monotherapy
- •previous participation in geriatric intervention studies
- •patients included in clinical trials with non-registered anticancer drugs
Outcomes
Primary Outcomes
Quality of Life (QoL): EORTC QLQ-C30
Time Frame: 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 Outcomes
- Evolution in QoL: EORTC QLQ-C30(over 1 year follow up since the start of the systemic therapy)
- Measurement of patient satisfaction: questionnaire(over 1 year follow up since the start of the systemic therapy)
- Evolution of functional status (FS) measured by Activities of Daily Living (ADL)(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)(over 1 year follow up since the start of the systemic therapy)
- Rate of falls(at 3, 6 and 12 months since the start of systemic therapy)
- QoL: EORTC QLQ-C30(QoL at 3 and 12 months since the start of the systemic therapy)
- Measurement of systemic therapy-related adverse events(over 1 year follow up since the start of the systemic therapy)
- Measurement of geriatric recommendations(at 3, 6 and 12 months since the start of systemic therapy)
- Measurement of actions undertaken(at 3, 6 and 12 months since the start of systemic therapy)
- Overall Survival(over 2 year follow-up since the start of systemic therapy)
- Number of patients with premature interruption of systemic therapy(over 1 year follow up since the start of the systemic therapy)