Supportive Care in Cancer

, Volume 26, Issue 1, pp 109–117 | Cite as

A randomized phase II trial of geriatric assessment and management for older cancer patients

  • Martine T. E. PutsEmail author
  • Schroder Sattar
  • Michael Kulik
  • Mary Ellen MacDonald
  • Kara McWatters
  • Katherine Lee
  • Sarah Brennenstuhl
  • Raymond Jang
  • Eitan Amir
  • Monika K. Krzyzanowska
  • Anthony M. Joshua
  • Johanne Monette
  • Doreen Wan-Chow-Wah
  • Shabbir M. H. Alibhai
Original Article



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 ( 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.


Comprehensive 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.

Supplementary material

520_2017_3820_MOESM1_ESM.docx (104 kb)
ESM 1 (DOCX 103 kb)


  1. 1.
    Howlader N, Noone AM, Krapcho M et al (2012) SEER Cancer Statistics Review, 1975–2009. National Cancer Institute, BethesdaGoogle Scholar
  2. 2.
    Santoni G, Angleman S, Welmer AK, Mangialasche F, Marengoni A, Fratiglioni L (2015) Age-related variation in health status after age 60. PLoS One 10(3):e0120077CrossRefGoogle Scholar
  3. 3.
    Wildiers H, Heeren P, Puts M et al (2014) International Society of Geriatric Oncology consensus on geriatric assessment in older patients with cancer. J Clin Oncol 32(24):2595–2603CrossRefGoogle Scholar
  4. 4.
    Hurria A, Wildes T, Baumgartner J, et al. (2016) NCCN Clinical Practice Guidelines in Oncology. Older Adult Oncology. Version 1.2016. NCCNGoogle Scholar
  5. 5.
    Pallis AG, Fortpied C, Wedding U et al (2010) EORTC elderly task force position paper: approach to the older cancer patient. Eur J Cancer 46(9):1502–1513CrossRefGoogle Scholar
  6. 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:
  7. 7.
    Charlson ME, Pompei P, Ales KL, MacKenzie CR (1987) A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis 40(5):373–383CrossRefGoogle Scholar
  8. 8.
    Fillenbaum GG, Smyer MA (1981) The development, validity, and reliability of the OARS multidimensional functional assessment questionnaire. J Gerontol 36(4):428–434CrossRefGoogle Scholar
  9. 9.
    Bergman H, Ferrucci L, Guralnik J et al (2007) Frailty: an emerging research and clinical paradigm—issues and controversies. J Gerontol A Biol Sci Med Sci 62(7):731–737CrossRefGoogle Scholar
  10. 10.
    Fried LP, Tangen CM, Walston J et al (2001) Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci 56(3):M146–M156CrossRefGoogle Scholar
  11. 11.
    Puts MT, Monette J, Girre V et al (2011) Are frailty markers useful for predicting treatment toxicity and mortality in older newly diagnosed cancer patients? Results from a prospective pilot study. Crit Rev Oncol Hematol 78(2):138–149CrossRefGoogle Scholar
  12. 12.
    Puts MT, Monette J, Girre V et al (2010) Does frailty predict hospitalization, emergency department visits, and visits to the general practitioner in older newly-diagnosed cancer patients? Results of a prospective pilot study. Crit Rev Oncol Hematol 76(2):142–151CrossRefGoogle Scholar
  13. 13.
    Borson S, Scanlan J, Brush M, Vitaliano P, Dokmak A (2000) The mini-cog: a cognitive ‘vital signs’ measure for dementia screening in multi-lingual elderly. Int J Geriatr Psychiatry 15(11):1021–1027CrossRefGoogle Scholar
  14. 14.
    Guralnik JM, Simonsick EM, Ferrucci L et al (1994) A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol 49(2):M85–M94CrossRefGoogle Scholar
  15. 15.
    Bruera E, Kuehn N, Miller MJ, Selmser P, Macmillan K (1991) The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care 7(2):6–9CrossRefGoogle Scholar
  16. 16.
    Kroenke K, Spitzer RL, Williams JB (2001) The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 16(9):606–613CrossRefGoogle Scholar
  17. 17.
    Hurria A, Togawa K, Mohile SG et al (2011) Predicting chemotherapy toxicity in older adults with cancer: a prospective multicenter study. J Clin Oncol 29(25):3457–3465CrossRefGoogle Scholar
  18. 18.
    Thabane L, Ma J, Chu R et al (2010) A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol 10:1CrossRefGoogle Scholar
  19. 19.
    Aaronson NK, Ahmedzai S, Bergman B et al (1993) The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85(5):365–376CrossRefGoogle Scholar
  20. 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
  21. 21.
    Osoba D, Bezjak A, Brundage M, Zee B, Tu D, Pater J (2005) Analysis and interpretation of health-related quality-of-life data from clinical trials: basic approach of The National Cancer Institute of Canada Clinical Trials Group. Eur J Cancer 41(2):280–287CrossRefGoogle Scholar
  22. 22.
    Horgan AM, Leighl NB, Coate L et al (2012) Impact and feasibility of a comprehensive geriatric assessment in the oncology setting: a pilot study. Am J Clin Oncol 35(4):322–328CrossRefGoogle Scholar
  23. 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:
  24. 24.
    Saliba D, Elliott M, Rubenstein LZ et al (2001) The Vulnerable Elders Survey: a tool for identifying vulnerable older people in the community. J Am Geriatr Soc 49(12):1691–1699CrossRefGoogle Scholar
  25. 25.
    Sim J, Lewis M (2012) The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol 65(3):301–308CrossRefGoogle Scholar
  26. 26.
    Feeley N, Cossette S, Cote J et al (2009) The importance of piloting an RCT intervention. Can J Nurs Res 41(2):85–99PubMedGoogle Scholar
  27. 27.
    Hertzog MA (2008) Considerations in determining sample size for pilot studies. Res Nurs Health 31(2):180–191CrossRefGoogle Scholar
  28. 28.
    Muthen B, Asparouhov T, Hunter AM, Leuchter AF (2011) Growth modeling with nonignorable dropout: alternative analyses of the STAR*D antidepressant trial. Psychol Methods 16(1):17–33CrossRefGoogle Scholar
  29. 29.
    Muthen LK, Muthen BO (2009) Mplus user’s guide, Fifth edn. Muthen & Muthen, Los AngelesGoogle Scholar
  30. 30.
    Puts MT, Monette J, Girre V et al (2009) Participation of older newly-diagnosed cancer patients in an observational prospective pilot study: an example of recruitment and retention. BMC Cancer 9:277CrossRefGoogle Scholar
  31. 31.
    Puts MT, Santos B, Hardt J et al (2014) An update on a systematic review of the use of geriatric assessment for older adults in oncology. Ann Oncol 25(2):307–315CrossRefGoogle Scholar
  32. 32.
    Hamaker ME, Schiphorst AH, ten Bokkel HD, Schaar C, van Munster BC (2014) The effect of a geriatric evaluation on treatment decisions for older cancer patients—a systematic review. Acta Oncol 53(3):289–296CrossRefGoogle Scholar
  33. 33.
    Puts MT, Hardt J, Monette J, Girre V, Springall E, Alibhai SM (2012) Use of geriatric assessment for older adults in the oncology setting: a systematic review. J Natl Cancer Inst 104(15):1134–1164CrossRefGoogle Scholar

Copyright information

© Springer-Verlag GmbH Germany 2017

Authors and Affiliations

  • Martine T. E. Puts
    • 1
    Email author
  • Schroder Sattar
    • 1
  • Michael Kulik
    • 1
  • Mary Ellen MacDonald
    • 1
  • Kara McWatters
    • 1
  • Katherine Lee
    • 1
  • Sarah Brennenstuhl
    • 1
  • Raymond Jang
    • 2
  • Eitan Amir
    • 2
  • Monika K. Krzyzanowska
    • 2
  • Anthony M. Joshua
    • 2
    • 3
  • Johanne Monette
    • 4
  • Doreen Wan-Chow-Wah
    • 4
  • Shabbir M. H. Alibhai
    • 5
  1. 1.Lawrence S. Bloomberg Faculty of NursingUniversity of TorontoTorontoCanada
  2. 2.Department of Medical Oncology and Hematology, Princess Margaret Cancer CentreUniversity Health NetworkTorontoCanada
  3. 3.Department of Oncology, Kinghorn Cancer Centre and the Garvan Institute of Medical ResearchUniversity of New South WalesSydneyAustralia
  4. 4.Division of Geriatric MedicineMcGill UniversityMontrealCanada
  5. 5.Department of Medicine and Institute of Health Policy, Management, and EvaluationUniversity Health Network and University of TorontoTorontoCanada

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