Development of the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM): A toxicity subscale to measure quality of life in patients with cancer who are treated with ICMs

Aaron R Hansen; Kari Ala-Leppilampi; Chris McKillop; Lillian L Siu; Philippe L Bedard; Albiruni R Abdul Razak; Anna Spreafico; Srikala S Sridhar; Natasha Leighl; Marcus O Butler; David Hogg; Adrian Sacher; Amit M Oza; Rany Al-Agha; Catherine Maurice; Christopher T Chan; Shane Shapera; Jordan J Feld; Rosane Nisenbaum; Kimberly Webster; David Cella; Janet Parsons

doi:10.1002/cncr.32692

Development of the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM): A toxicity subscale to measure quality of life in patients with cancer who are treated with ICMs

Cancer. 2020 Apr 1;126(7):1550-1558. doi: 10.1002/cncr.32692. Epub 2020 Jan 8.

Authors

Aaron R Hansen^{1

2}, Kari Ala-Leppilampi³, Chris McKillop⁴, Lillian L Siu^{1

2}, Philippe L Bedard^{1

2}, Albiruni R Abdul Razak^{1

2}, Anna Spreafico^{1

2}, Srikala S Sridhar^{1

2}, Natasha Leighl^{1

2}, Marcus O Butler^{1

2}, David Hogg^{1

2}, Adrian Sacher^{1

2}, Amit M Oza^{1

2}, Rany Al-Agha⁵, Catherine Maurice^{1

6}, Christopher T Chan⁷, Shane Shapera⁸, Jordan J Feld⁹, Rosane Nisenbaum³, Kimberly Webster¹⁰, David Cella¹⁰, Janet Parsons^{3

11}

Affiliations

¹ Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.
² Division of Medical Oncology and Hematology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
³ Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.
⁴ Turalt Inc, Toronto, Ontario, Canada.
⁵ Division of Endocrinology and Metabolism, Alberta Diabetes Institute, University of Alberta, Edmonton, Alberta, Canada.
⁶ Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
⁷ Division of Nephrology, Department of Medicine, University Health Network, University of Toronto, Toronto, Ontario, Canada.
⁸ Division of Respirology, Department of Medicine, University Health Network, University of Toronto, Toronto, Ontario, Canada.
⁹ Toronto Centre for Liver Disease, Toronto General Hospital Research Institute, University Health Network, Toronto, Ontario, Canada.
¹⁰ Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
¹¹ Department of Physical Therapy and the Rehabilitation Sciences Institute, University of Toronto, Toronto, Ontario, Canada.

PMID: 31914209
DOI: 10.1002/cncr.32692

Abstract

Background: Patients with cancer who are treated with immune checkpoint modulators (ICMs) have their health-related quality of life (HRQOL) measured using general patient-reported outcome (PRO) tools. To the authors' knowledge, no instrument has been developed to date specifically for patients treated with ICMs. The objective of the current study was to develop a toxicity subscale PRO instrument for patients treated with ICMs to assess HRQOL.

Methods: Input was collected from a systematic review as well as patients and physicians experienced with ICM treatment. Descriptive thematic analysis was used to evaluate the qualitative data obtained from patient focus groups and interviews, which informed an initial list of items that described ICM side effects and their impact on HRQOL. These inputs informed item generation and/or reduction to develop a toxicity subscale.

Results: Focus groups and individual interviews with 37 ICM-treated patients generated an initial list of 176 items. After a first round of item reduction that produced a shortened list of 76 items, 16 physicians who care for patients who are treated with ICMs were surveyed with a list of 49 patient-reported side effects and 11 physicians participated in follow-up interviews. A second round of item reduction was informed by the physician responses to produce a list of 25 items.

Conclusions: To the authors' knowledge, this 25-item list is the first HRQOL-focused toxicity subscale for patients treated with ICMs and was developed in accordance with US Food and Drug Administration guidelines, which prioritize patient input in developing PRO tools. The subscale will be combined with the Functional Assessment of Cancer Therapy-General (FACT-G) to form the FACT-ICM. Prior to recommending the formal use of this PRO instrument, the authors will evaluate its validity and reliability in longitudinal studies involving substantially more patients.

Keywords: costimulatory antibodies; health-related quality of life (HRQOL); immune checkpoint inhibitor; immunotherapy; patient-reported outcomes (PROs).

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Adult
Aged
Aged, 80 and over
Female
Humans
Immunotherapy / adverse effects*
Male
Middle Aged
Neoplasms / drug therapy*
Patient Reported Outcome Measures*
Psychometrics / instrumentation*
Quality of Life*