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

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Geriatrics; Comprehensive Geriatric Assessment

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04069962

s62123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 204 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

Control group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

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