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GeriatricsG-oncoCOACHNCT04069962

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

A study testing CGA coordination by geriatric team including intensive patient coaching and follow-up in people with Geriatrics and Comprehensive Geriatric Assessment, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
CGA coordination by geriatric team including intensive patient coaching and follow-up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
1 siteBelgium
Study dates
30 Oct 2019to 25 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • UZ Gasthuisberg Leuven

    Leuven, B-3000

Other trials in Belgium

About this study

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

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.

Read the 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.

Being tested
CGA coordination by geriatric team including intensive patient coaching and follow-up
Keywords
cancer, older persons, comprehensive geriatric assessment, geriatric interventions, patient compliance
Medical subject headings
Neoplasms, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CGA coordination by geriatric team including intensive patient coaching and follow-upBehavioural

    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.

Study groups in NCT04069962
Study groupRoleWhat they receive
Control groupNo interventionPatients 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 groupExperimentalPatients 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.
Receives: Behavioral: CGA coordination by geriatric team including intensive patient coaching and follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: QoL at 6 months since the start of the systemic therapy

Secondary outcomes (11)

  1. 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.

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

  2. 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.

    Measured: over 1 year follow up since the start of the systemic therapy

  3. 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))

    Measured: over 1 year follow up since the start of the systemic therapy

  4. 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).

    Measured: over 1 year follow up since the start of the systemic therapy

  5. 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).

    Measured: over 1 year follow up since the start of the systemic therapy

  6. Rate of falls

    Rate of falls measured by self-report of fall history

    Measured: at 3, 6 and 12 months since the start of systemic therapy

  7. 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

    Measured: over 1 year follow up since the start of the systemic therapy

  8. Measurement of geriatric recommendations

    Number of geriatric recommendations and adherence of geriatric recommendations (= geriatric interventions)

    Measured: at 3, 6 and 12 months since the start of systemic therapy

  9. 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.

    Measured: at 3, 6 and 12 months since the start of systemic therapy

  10. Overall Survival

    the length of time from the start of treatment and death from any cause

    Measured: over 2 year follow-up since the start of systemic therapy

  11. 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.

    Measured: over 1 year follow up since the start of the systemic therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start30 Oct 2019
  3. Primary completion31 Dec 2022
  4. Study completion25 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04069962
Sponsor's protocol ID
s62123
Acronym
G-oncoCOACH
Status last verified
Mar 2023
First submitted
16 Aug 2019
Last updated
29 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40818480

Questions about this trial

What is this clinical trial studying?

A study testing CGA coordination by geriatric team including intensive patient coaching and follow-up in people with Geriatrics and Comprehensive Geriatric Assessment, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life (QoL): EORTC QLQ-C30 (time frame: QoL at 6 months since the start of the systemic therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04069962, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.

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