Clinical trial NCT04069962: Effectiveness of CGA on QoL in Older Patients With Cancer Receiving Systemic Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Geriatrics
Comprehensive Geriatric Assessment
Keywords: cancer
older persons
comprehensive geriatric assessment
geriatric interventions
patient compliance
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Kom Op Tegen Kanker
name: Universitair Ziekenhuis Brussel
First posted: 2019-08-28
Enrollment: 204
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Quality of Life (QoL): EORTC QLQ-C30
timeFrame: QoL at 6 months since the start of the systemic therapy
Secondary outcomes:
measure: QoL: EORTC QLQ-C30
timeFrame: QoL at 3 and 12 months since the start of the systemic therapy
measure: Evolution in QoL: EORTC QLQ-C30
timeFrame: over 1 year follow up since the start of the systemic therapy
measure: Measurement of patient satisfaction: questionnaire
timeFrame: over 1 year follow up since the start of the systemic therapy
measure: Evolution of functional status (FS) measured by Activities of Daily Living (ADL)
timeFrame: over 1 year follow up since the start of the systemic therapy
measure: Evolution of functional status (FS) measured by Instrumental Activities of Daily Living (IADL)
timeFrame: over 1 year follow up since the start of the systemic therapy
measure: Rate of falls
timeFrame: at 3, 6 and 12 months since the start of systemic therapy
measure: Measurement of systemic therapy-related adverse events
timeFrame: over 1 year follow up since the start of the systemic therapy
measure: Measurement of geriatric recommendations
timeFrame: at 3, 6 and 12 months since the start of systemic therapy
measure: Measurement of actions undertaken
timeFrame: at 3, 6 and 12 months since the start of systemic therapy
measure: Overall Survival
timeFrame: over 2 year follow-up since the start of systemic therapy
measure: Number of patients with premature interruption of systemic therapy
timeFrame: over 1 year follow up since the start of the systemic therapy
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Gasthuisberg Leuven
Study officials:
affiliation: adjunct head of clinic
name: Hans Wildiers, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: