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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-30

Study Completion Date

2023-03-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Geriatrics Comprehensive Geriatric Assessment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No