Martine T E Puts1, Schroder Sattar2, Michael Kulik2, Mary Ellen MacDonald2, Kara McWatters2, Katherine Lee2, Sarah Brennenstuhl2, Raymond Jang3, Eitan Amir3, Monika K Krzyzanowska3, Anthony M Joshua3,4, Johanne Monette5, Doreen Wan-Chow-Wah5, Shabbir M H Alibhai6. 1. Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Suite 130, Toronto, ON, M5T1P8, Canada. martine.puts@utoronto.ca. 2. Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Suite 130, Toronto, ON, M5T1P8, Canada. 3. Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada. 4. Department of Oncology, Kinghorn Cancer Centre and the Garvan Institute of Medical Research, University of New South Wales, Sydney, Australia. 5. Division of Geriatric Medicine, McGill University, Montreal, QC, Canada. 6. Department of Medicine and Institute of Health Policy, Management, and Evaluation, University Health Network and University of Toronto, Toronto, ON, Canada.
Abstract
PURPOSE:Geriatric assessment and management (GAM) can identify current health issues and recommend interventions to optimize well-being of older adults, but no randomized trial has yet been completed in oncology. Therefore, a randomized phase 2 trial was conducted. METHODS: A two-group parallel single-blinded randomized phase II trial ( ClinicalTrials.gov Identifier: NCT02222259) enrolled patients aged ≥70 years, diagnosed with stage 2-4 gastrointestinal, genitourinary, or breast cancer within 6 weeks of commencing chemotherapy at Princess Margaret Cancer Centre. The coprimary feasibility outcomes were the proportion of eligible patients enrolled and retained. The coprimary clinical outcomes were quality of life (QOL) (EORTC QLQ C30) and modification of cancer treatment. Descriptive and regression analyses using intent-to-treat analysis were conducted. RESULTS:Sixty-one persons (64%) agreed to participate (31 allocated to intervention arm and 30 to control group). In the control group, more participants died and refused follow-up. The benefit of intervention over control on QOL at 3 months was greater for those who survived 6 months (difference 9.28; 95% CI -10.35 to 28.91) versus those who survived only 3 months (difference 6.55; 95% CI -9.63 to 22.73). CONCLUSIONS: This trial showed that it was feasible to recruit and retain older adults for a GAM study. Those who survived at least 6 months seemed to receive a greater QOL benefit than those who died or withdrew.
RCT Entities:
PURPOSE: Geriatric assessment and management (GAM) can identify current health issues and recommend interventions to optimize well-being of older adults, but no randomized trial has yet been completed in oncology. Therefore, a randomized phase 2 trial was conducted. METHODS: A two-group parallel single-blinded randomized phase II trial ( ClinicalTrials.gov Identifier: NCT02222259) enrolled patients aged ≥70 years, diagnosed with stage 2-4 gastrointestinal, genitourinary, or breast cancer within 6 weeks of commencing chemotherapy at Princess Margaret Cancer Centre. The coprimary feasibility outcomes were the proportion of eligible patients enrolled and retained. The coprimary clinical outcomes were quality of life (QOL) (EORTC QLQ C30) and modification of cancer treatment. Descriptive and regression analyses using intent-to-treat analysis were conducted. RESULTS: Sixty-one persons (64%) agreed to participate (31 allocated to intervention arm and 30 to control group). In the control group, more participants died and refused follow-up. The benefit of intervention over control on QOL at 3 months was greater for those who survived 6 months (difference 9.28; 95% CI -10.35 to 28.91) versus those who survived only 3 months (difference 6.55; 95% CI -9.63 to 22.73). CONCLUSIONS: This trial showed that it was feasible to recruit and retain older adults for a GAM study. Those who survived at least 6 months seemed to receive a greater QOL benefit than those who died or withdrew.
Entities:
Keywords:
Aged; Cancer; Comprehensive geriatric assessment; Functional status; Integrated care; Quality of life
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