Effectiveness of CGA on QoL in Older Patients With Cancer Receiving Systemic Therapy (G-oncoCOACH)

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

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.

Study Overview

• Status: Completed
• Conditions: Geriatrics; Comprehensive Geriatric Assessment
• Intervention / Treatment: Behavioral: CGA coordination by geriatric team including intensive patient coaching and follow-up

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.

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, B-3000
    • UZ Gasthuisberg Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Patients in the control group will receive CGA coordinated by the oncology team as standard of care, including geriatric recommendations for interventions communicated to the treating physician (eg. referral to the social worker, psychologist, dietician).
Experimental: Intervention group; 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.	Behavioral: CGA coordination by geriatric team including intensive patient coaching and follow-up; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: Universitair Ziekenhuis Brussel; Kom Op Tegen Kanker

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): March 25, 2023

Study Registration Dates

• First Submitted: August 16, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: cancer; comprehensive geriatric assessment; older persons; patient compliance; geriatric interventions
• Other Study ID Numbers: s62123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No