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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069962
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : August 30, 2019
Sponsor:
Collaborators:
Kom Op Tegen Kanker
Universitair Ziekenhuis Brussel
Information provided by (Responsible Party):
prof. dr. Hans Wildiers, Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment Phase
Geriatrics Comprehensive Geriatric Assessment Behavioral: CGA coordination by geriatric team including intensive patient coaching and follow-up Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069962


Contacts
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Contact: Hans Wildiers, prof. dr. 003216346900 hans.wildiers@uzleuven.be
Contact: Cindy Kenis, PhD 003216341369 cindy.kenis@uzleuven.be

Locations
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Belgium
UZ Gasthuisberg Leuven
Leuven, Belgium, B-3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Kom Op Tegen Kanker
Universitair Ziekenhuis Brussel
Investigators
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Principal Investigator: Hans Wildiers, prof. dr. adjunct head of clinic
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Responsible Party: prof. dr. Hans Wildiers, Principal Investigator, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04069962    
Other Study ID Numbers: s62123
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by prof. dr. Hans Wildiers, Universitaire Ziekenhuizen Leuven:
cancer
older persons
comprehensive geriatric assessment
geriatric interventions
patient compliance