Effectiveness of CGA on QoL in Older Patients With Cancer Receiving Systemic Therapy

NCT04069962 | Completed

• 1 other identifier: s62123
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Geriatrics; Comprehensive Geriatric Assessment

Keywords

cancer; older persons; comprehensive geriatric assessment; geriatric interventions; patient compliance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• QoL: EORTC QLQ-C30

  QoL at 3 and 12 months since the start of the systemic therapy

• 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

Study Arms (2)

Control group

NO INTERVENTION

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).

Intervention group

EXPERIMENTAL

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

Interventions

CGA coordination by geriatric team including intensive patient coaching and follow-up BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients with antihormonal monotherapy
• previous participation in geriatric intervention studies
• patients included in clinical trials with non-registered anticancer drugs

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Kom Op Tegen Kanker: collaborator
• Universitair Ziekenhuis Brussel: collaborator

Study Sites (1)

UZ Gasthuisberg Leuven

Leuven, B-3000, Belgium

Location

Related Publications (1)

• Kenis C, Peeters L, Laethem L, De Cock J, Compte N, Flamaing J, Milisen K, Fagard K, Lobelle JP, Laenen A, Decoster L, Wildiers H. Effectiveness of comprehensive geriatric assessment with extensive patient coaching for improving quality of life in older patients with solid tumours receiving systemic therapy (G-oncoCOACH): a multicentre randomised controlled trial. Lancet Healthy Longev. 2025 Aug;6(8):100743. doi: 10.1016/j.lanhl.2025.100743. Epub 2025 Aug 13.

  PMID: 40818480 DERIVED

MeSH Terms

Conditions

Neoplasms; Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Hans Wildiers, prof. dr.

  adjunct head of clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 28, 2019
• Study Start: October 30, 2019
• Primary Completion: December 31, 2022
• Study Completion: March 25, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)