A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients (A GEM Study for Older Cancer Patients)
A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients (A GEM Study for Older Cancer Patients)
The purpose of this study is to determine the feasibility of implementing a randomized controlled study of the intervention (Geriatric Assessment followed by an integrated care plan carried out by the multidisciplinary geriatric oncology team) designed to maintain/improve quality of life and functional status in older adults with advanced gastrointestinal, genitourinary or breast cancer referred for first line chemotherapy.
Secondarily, the study will investigate the impact of the Geriatric Assessment on the cancer treatment decision of the cancer specialist.
Introduction: A comprehensive geriatric assessment (CGA) can identify functional and psychosocial issues in older cancer patients, which in turn can inform interventions to prevent/postpone adverse outcomes and maintain/improve the functional status and well-being of this population. However, few randomized controlled trials (RCTs) have been completed showing the evidence.
OBJECTIVE - To explore the feasibility and impact of a CGA followed by an integrated care plan on quality of life and functional status for older adults with advanced breast, gastrointestinal or genitourinary cancer METHODS -
A two-group parallel single-blind phase II RCT is enrolling 60 patients aged 70 or above, diagnosed with cancer, and starting first line chemotherapy at Princess Margaret Cancer Centre in Toronto. The randomization using sealed opaque envelopes is stratified by treatment intent (adjuvant versus palliative). The intervention entails a comprehensive CGA by a multidisciplinary geriatric oncology team followed by an integrated care plan to address any issues identified. Participants in the intervention group are seen at baseline for the CGA and for initiation of the integrated care plan, and again at 3 and 6 months to assess intervention fidelity and measure outcomes. The co-primary outcomes are: 1) maintaining/improvement in quality of life; 2) refining of cancer treatment plan. The secondary outcomes include: 1) Functional status; 2) feasibility of the study by tumor site.
Recruitment has been completed November 2015
Inclusion Criteria:
Exclusion Criteria: