Skip to main content

Advertisement

SpringerLink
Log in

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

  • Original Article
  • Published:
Supportive Care in Cancer Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. Howlader N, Noone AM, Krapcho M et al (2012) SEER Cancer Statistics Review, 1975–2009. National Cancer Institute, Bethesda

    Google Scholar 

  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):e0120077

    Article  Google Scholar 

  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):2595–2603

    Article  Google Scholar 

  4. Hurria A, Wildes T, Baumgartner J, et al. (2016) NCCN Clinical Practice Guidelines in Oncology. Older Adult Oncology. Version 1.2016. NCCN

  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):1502–1513

    Article  CAS  Google 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/

  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):373–383

    Article  CAS  Google Scholar 

  8. Fillenbaum GG, Smyer MA (1981) The development, validity, and reliability of the OARS multidimensional functional assessment questionnaire. J Gerontol 36(4):428–434

    Article  CAS  Google Scholar 

  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):731–737

    Article  Google Scholar 

  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–M156

    Article  CAS  Google Scholar 

  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):138–149

    Article  Google Scholar 

  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):142–151

    Article  CAS  Google Scholar 

  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):1021–1027

    Article  CAS  Google Scholar 

  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–M94

    Article  CAS  Google Scholar 

  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):6–9

    Article  CAS  Google Scholar 

  16. Kroenke K, Spitzer RL, Williams JB (2001) The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 16(9):606–613

    Article  CAS  Google Scholar 

  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):3457–3465

    Article  CAS  Google Scholar 

  18. Thabane L, Ma J, Chu R et al (2010) A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol 10:1

    Article  Google Scholar 

  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):365–376

    Article  CAS  Google Scholar 

  20. Fayers PM, Aaronson NK, Bjordal K et al (2001) The EORTC QLQ-C30 scoring manual. European Organisation for Research and Treatment of Cancer, Brussel

    Google Scholar 

  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):280–287

    Article  Google Scholar 

  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):322–328

    Article  Google 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

  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):1691–1699

    Article  CAS  Google Scholar 

  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):301–308

    Article  Google Scholar 

  26. Feeley N, Cossette S, Cote J et al (2009) The importance of piloting an RCT intervention. Can J Nurs Res 41(2):85–99

    PubMed  Google Scholar 

  27. Hertzog MA (2008) Considerations in determining sample size for pilot studies. Res Nurs Health 31(2):180–191

    Article  Google Scholar 

  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):17–33

    Article  Google Scholar 

  29. Muthen LK, Muthen BO (2009) Mplus user’s guide, Fifth edn. Muthen & Muthen, Los Angeles

    Google Scholar 

  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 9:277

    Article  Google Scholar 

  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):307–315

    Article  CAS  Google Scholar 

  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):289–296

    Article  Google Scholar 

  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):1134–1164

    Article  Google Scholar 

Download references

Acknowledgements

We would like to thank all staff and participants of the Princess Margaret Cancer Centre for their support.

Author information

Authors and Affiliations

  1. Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Suite 130, Toronto, ON, M5T1P8, Canada

    Martine T. E. Puts, Schroder Sattar, Michael Kulik, Mary Ellen MacDonald, Kara McWatters, Katherine Lee & Sarah Brennenstuhl

  2. Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada

    Raymond Jang, Eitan Amir, Monika K. Krzyzanowska & Anthony M. Joshua

  3. Department of Oncology, Kinghorn Cancer Centre and the Garvan Institute of Medical Research, University of New South Wales, Sydney, Australia

    Anthony M. Joshua

  4. Division of Geriatric Medicine, McGill University, Montreal, QC, Canada

    Johanne Monette & Doreen Wan-Chow-Wah

  5. Department of Medicine and Institute of Health Policy, Management, and Evaluation, University Health Network and University of Toronto, Toronto, ON, Canada

    Shabbir M. H. Alibhai

Authors
  1. Martine T. E. Puts
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Schroder Sattar
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Michael Kulik
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Mary Ellen MacDonald
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Kara McWatters
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Katherine Lee
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Sarah Brennenstuhl
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Raymond Jang
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Eitan Amir
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Monika K. Krzyzanowska
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Anthony M. Joshua
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Johanne Monette
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Doreen Wan-Chow-Wah
    View author publications

    You can also search for this author in PubMed Google Scholar

  14. Shabbir M. H. Alibhai
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Martine T. E. Puts.

Ethics declarations

Funding

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.

Electronic supplementary material

ESM 1

(DOCX 103 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Puts, M.T.E., Sattar, S., Kulik, M. et al. A randomized phase II trial of geriatric assessment and management for older cancer patients. Support Care Cancer 26, 109–117 (2018). https://doi.org/10.1007/s00520-017-3820-7

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00520-017-3820-7

Keywords

Search

Navigation