A randomized phase II trial of geriatric assessment and management for older cancer patients
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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.
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.
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).
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.
KeywordsComprehensive geriatric assessment Cancer Aged Functional status Quality of life Integrated care
We would like to thank all staff and participants of the Princess Margaret Cancer Centre for their support.
Compliance with ethical standards
This work was funded by a research pilot grant from the Lawrence S. Bloomberg Faculty of Nursing, University of Toronto. Dr. Puts is supported by a Canadian Institutes of Health Research New Investigator Award.
Conflict of interest
The authors declare they have no conflicts of interest.
Research involving human participants and informed consent
All procedures performed in this study were in accordance with the ethical standards of the University Health Network and University of Toronto Health Sciences Research Ethics board. Informed consent was obtained from all individual participants included in the study.
- 1.Howlader N, Noone AM, Krapcho M et al (2012) SEER Cancer Statistics Review, 1975–2009. National Cancer Institute, BethesdaGoogle Scholar
- 4.Hurria A, Wildes T, Baumgartner J, et al. (2016) NCCN Clinical Practice Guidelines in Oncology. Older Adult Oncology. Version 1.2016. NCCNGoogle Scholar
- 6.Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Pettricrew M, on behalf of the Medical Research Council (2008) Developing and evaluating complex interventions: new guidance. Medical Research Council. Available from: URL: http://www.mrc.ac.uk/documents/pdf/complex-interventions-guidance/
- 20.Fayers PM, Aaronson NK, Bjordal K et al (2001) The EORTC QLQ-C30 scoring manual. European Organisation for Research and Treatment of Cancer, BrusselGoogle Scholar
- 23.Soubeyran P, Bellera C, Goyard J, et al. Validation of the G8 screening tool in geriatric oncology: the ONCODAGE project. . J Clin Oncol 201129(15 SUPPL. 1). Available from: URL: http://meeting.ascopubs.org/cgi/content/abstract/29/15-suppl/9001?sid=c2b1c10e-894c-49ae-981a-f2919f8bfa6f
- 29.Muthen LK, Muthen BO (2009) Mplus user’s guide, Fifth edn. Muthen & Muthen, Los AngelesGoogle Scholar