Skip to main content
OpenTrials
Completed

NCT Number: NCT04069962

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Gasthuisberg Leuven

Leuven, B-3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. QoL: EORTC QLQ-C30

    Time frame: QoL at 3 and 12 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.

  2. Evolution in QoL: EORTC QLQ-C30

    Time frame: over 1 year follow up 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.

  3. Measurement of patient satisfaction: questionnaire

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

    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))

  4. Evolution of functional status (FS) measured by Activities of Daily Living (ADL)

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

    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).

  5. Evolution of functional status (FS) measured by Instrumental Activities of Daily Living (IADL)

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

    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).

  6. Rate of falls

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

    Rate of falls measured by self-report of fall history

  7. Measurement of systemic therapy-related adverse events

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

    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

  8. Measurement of geriatric recommendations

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

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

  9. Measurement of actions undertaken

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

    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.

  10. Overall Survival

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

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

  11. Number of patients with premature interruption of systemic therapy

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

    Premature interruption of systemic therapy is defined as the complete discontinuation of the systemic therapy the patient receives in this study.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Kom Op Tegen Kanker
  • Universitair Ziekenhuis Brussel

Registry information

Official study 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

Acronym: G-oncoCOACH

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Aug 28, 2019
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.