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 Richard HansenKari Ala-LeppilampiChris McKillopLillian L SiuPhilippe L BedardAlbiruni R Abdul RazakAnna SpreaficoSrikala S SridharNatasha LeighlMarcus O ButlerDavid HoggAdrian SacherAmit M OzaRany Al-AghaCatherine MauriceChristopher T ChanShane ShaperaJordan J FeldRosane NisenbaumKimberly WebsterDavid CellaJanet ParsonsPublished in: Cancer (2020)
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.