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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. Puts
  • 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

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.

Keywords

Comprehensive geriatric assessment Cancer Aged Functional status Quality of life Integrated care 

Notes

Acknowledgements

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

Compliance with ethical standards

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.

Supplementary material

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

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Copyright information

© Springer-Verlag GmbH Germany 2017

Authors and Affiliations

  • Martine T. E. Puts
    • 1
  • 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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