Development of the Functional Assessment of Cancer Therapy-Carcinoid Syndrome Symptom Index

Sara Shaunfield; Kimberly A. Webster; Karen Kaiser; George J. Greene; Susan E. Yount; Leilani Lacson; Al B. Benson; Daniel M. Halperin; James C. Yao; Simron Singh; Marion Feuilly; Florence Marteau; David Cella

doi:10.1159/000511482

Development of the Functional Assessment of Cancer Therapy-Carcinoid Syndrome Symptom Index

Sara Shaunfield^*, Kimberly A. Webster, Karen Kaiser, George J. Greene, Susan E. Yount, Leilani Lacson, Al B. Benson, Daniel M. Halperin, James C. Yao, Simron Singh, Marion Feuilly, Florence Marteau, David Cella

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

4 Scopus citations

Abstract

Objective: To develop a symptom-focused index to evaluate representative symptoms, treatment side effects, and emotional and functional well-being of patients with carcinoid syndrome (CS). Methods: The development of the Functional Assessment of Cancer Therapy-Carcinoid Syndrome Symptom Index (FACT-CSI) followed US Food and Drug Administration guidelines for the development of patient-reported outcome (PRO) measures and involved the following: (a) literature review; (b) interviews with 14 CS patients; (c) interviews with 9 clinicians; and (d) instrument development involving input from a range of PRO measure development and CS experts. The resulting draft instrument underwent cognitive interviews with 7 CS patients. Results: Forty-six CS sources were reviewed. Analysis of patient interviews produced 23 patient-reported symptoms. The most frequently endorsed physical symptoms were flushing, diarrhea, abdominal pain, fatigue, and food sensitivity/triggers. Seven priority CS emotional and functional themes were also identified by patients. Expert interviews revealed 12 unique priority symptoms - the most common being diarrhea, flushing, wheezing, edema, abdominal pain/cramping, fatigue, and 8 emotional and functional concerns. Through an iterative process of team and clinical collaborator meetings, data review, item reduction and measure revision, 24 items were selected for the draft symptom index representing symptoms, emotional concerns, global assessment of treatment side effects, and functional well-being. Cognitive interview results demonstrated strong content validity, including positive endorsement of item clarity (>86% across items), symptom relevance (>70% for most items), and overall measure content (86%). Conclusions: The FACT-CSI is a content-relevant, symptom-focused index reflecting the highest priority and clinically relevant symptoms and concerns of people with CS.

Original language	English (US)
Pages (from-to)	850-862
Number of pages	13
Journal	Neuroendocrinology
Volume	111
Issue number	9
DOIs	https://doi.org/10.1159/000511482
State	Published - Aug 1 2021

Funding

S. Shaunfield received research funding from Ipsen, Daiichi Sankyo, Abbvie, Alexion, and EMD Serono. K.A.W. received research funding from AbbVie, is the director of communications for and part owner of FACIT.org and FACITTrans. K.K. received research funding from Ipsen, Alexion, and EMD Serono. G.J.G. received research funding from Ipsen. S.E.Y. received research funding from the American Thoracic Society Foundation. L.L. has no conflicts of interest to declare. A.B.B. serves as a consultant to Bayer, Genentech, & Novartis. D.M.H. received research funding from Genentech, Tarveda, Ipsen, Thermofisher Scientific, Advanced Accelerator Applications, and Novartis, and serves as a consultant to Lexicon, Advanced Accelerator Applications, Ipsen, Abbvie, and Novartis. J.C.Y. serves as a consultant to Novartis, Ipsen, Hutchinson MediPharma, Crinetics, Tarveda Therapeutics, and Merck Sharp & Dohme. S. Singh received honoraria from Ipsen and Novartis; received research funding from Novartis and EMD SErono. M.F. is a full-time employee of AbbVie and may own AbbVie stock or stock options. F.M. is a full-time employee of AbbVie. D.C. received research funding from Ipsen and serves as a consultant to Lexicon, Novartis, and Ipsen, and is president of FACIT.org.

Keywords

Carcinoid syndrome
Measure development
Priority symptoms
Qualitative methods
Symptom index

ASJC Scopus subject areas

Endocrine and Autonomic Systems
Endocrinology
Cellular and Molecular Neuroscience
Endocrinology, Diabetes and Metabolism

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1159/000511482

Cite this

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title = "Development of the Functional Assessment of Cancer Therapy-Carcinoid Syndrome Symptom Index",

abstract = "Objective: To develop a symptom-focused index to evaluate representative symptoms, treatment side effects, and emotional and functional well-being of patients with carcinoid syndrome (CS). Methods: The development of the Functional Assessment of Cancer Therapy-Carcinoid Syndrome Symptom Index (FACT-CSI) followed US Food and Drug Administration guidelines for the development of patient-reported outcome (PRO) measures and involved the following: (a) literature review; (b) interviews with 14 CS patients; (c) interviews with 9 clinicians; and (d) instrument development involving input from a range of PRO measure development and CS experts. The resulting draft instrument underwent cognitive interviews with 7 CS patients. Results: Forty-six CS sources were reviewed. Analysis of patient interviews produced 23 patient-reported symptoms. The most frequently endorsed physical symptoms were flushing, diarrhea, abdominal pain, fatigue, and food sensitivity/triggers. Seven priority CS emotional and functional themes were also identified by patients. Expert interviews revealed 12 unique priority symptoms - the most common being diarrhea, flushing, wheezing, edema, abdominal pain/cramping, fatigue, and 8 emotional and functional concerns. Through an iterative process of team and clinical collaborator meetings, data review, item reduction and measure revision, 24 items were selected for the draft symptom index representing symptoms, emotional concerns, global assessment of treatment side effects, and functional well-being. Cognitive interview results demonstrated strong content validity, including positive endorsement of item clarity (>86% across items), symptom relevance (>70% for most items), and overall measure content (86%). Conclusions: The FACT-CSI is a content-relevant, symptom-focused index reflecting the highest priority and clinically relevant symptoms and concerns of people with CS.",

keywords = "Carcinoid syndrome, Measure development, Priority symptoms, Qualitative methods, Symptom index",

author = "Sara Shaunfield and Webster, {Kimberly A.} and Karen Kaiser and Greene, {George J.} and Yount, {Susan E.} and Leilani Lacson and Benson, {Al B.} and Halperin, {Daniel M.} and Yao, {James C.} and Simron Singh and Marion Feuilly and Florence Marteau and David Cella",

note = "Funding Information: S. Shaunfield received research funding from Ipsen, Daiichi Sankyo, Abbvie, Alexion, and EMD Serono. K.A.W. received research funding from AbbVie, is the director of communications for and part owner of FACIT.org and FACITTrans. K.K. received research funding from Ipsen, Alexion, and EMD Serono. G.J.G. received research funding from Ipsen. S.E.Y. received research funding from the American Thoracic Society Foundation. L.L. has no conflicts of interest to declare. A.B.B. serves as a consultant to Bayer, Genentech, & Novartis. D.M.H. received research funding from Genentech, Tarveda, Ipsen, Thermofisher Scientific, Advanced Accelerator Applications, and Novartis, and serves as a consultant to Lexicon, Advanced Accelerator Applications, Ipsen, Abbvie, and Novartis. J.C.Y. serves as a consultant to Novartis, Ipsen, Hutchinson MediPharma, Crinetics, Tarveda Therapeutics, and Merck Sharp & Dohme. S. Singh received honoraria from Ipsen and Novartis; received research funding from Novartis and EMD SErono. M.F. is a full-time employee of AbbVie and may own AbbVie stock or stock options. F.M. is a full-time employee of AbbVie. D.C. received research funding from Ipsen and serves as a consultant to Lexicon, Novartis, and Ipsen, and is president of FACIT.org. Publisher Copyright: {\textcopyright} 2020 S. Karger AG, Basel. Copyright: All rights reserved.",

year = "2021",

month = aug,

day = "1",

doi = "10.1159/000511482",

language = "English (US)",

volume = "111",

pages = "850--862",

journal = "Neuroendocrinology",

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TY - JOUR

T1 - Development of the Functional Assessment of Cancer Therapy-Carcinoid Syndrome Symptom Index

AU - Shaunfield, Sara

AU - Webster, Kimberly A.

AU - Kaiser, Karen

AU - Greene, George J.

AU - Yount, Susan E.

AU - Lacson, Leilani

AU - Benson, Al B.

AU - Halperin, Daniel M.

AU - Yao, James C.

AU - Singh, Simron

AU - Feuilly, Marion

AU - Marteau, Florence

AU - Cella, David

N1 - Funding Information: S. Shaunfield received research funding from Ipsen, Daiichi Sankyo, Abbvie, Alexion, and EMD Serono. K.A.W. received research funding from AbbVie, is the director of communications for and part owner of FACIT.org and FACITTrans. K.K. received research funding from Ipsen, Alexion, and EMD Serono. G.J.G. received research funding from Ipsen. S.E.Y. received research funding from the American Thoracic Society Foundation. L.L. has no conflicts of interest to declare. A.B.B. serves as a consultant to Bayer, Genentech, & Novartis. D.M.H. received research funding from Genentech, Tarveda, Ipsen, Thermofisher Scientific, Advanced Accelerator Applications, and Novartis, and serves as a consultant to Lexicon, Advanced Accelerator Applications, Ipsen, Abbvie, and Novartis. J.C.Y. serves as a consultant to Novartis, Ipsen, Hutchinson MediPharma, Crinetics, Tarveda Therapeutics, and Merck Sharp & Dohme. S. Singh received honoraria from Ipsen and Novartis; received research funding from Novartis and EMD SErono. M.F. is a full-time employee of AbbVie and may own AbbVie stock or stock options. F.M. is a full-time employee of AbbVie. D.C. received research funding from Ipsen and serves as a consultant to Lexicon, Novartis, and Ipsen, and is president of FACIT.org. Publisher Copyright: © 2020 S. Karger AG, Basel. Copyright: All rights reserved.

PY - 2021/8/1

Y1 - 2021/8/1

N2 - Objective: To develop a symptom-focused index to evaluate representative symptoms, treatment side effects, and emotional and functional well-being of patients with carcinoid syndrome (CS). Methods: The development of the Functional Assessment of Cancer Therapy-Carcinoid Syndrome Symptom Index (FACT-CSI) followed US Food and Drug Administration guidelines for the development of patient-reported outcome (PRO) measures and involved the following: (a) literature review; (b) interviews with 14 CS patients; (c) interviews with 9 clinicians; and (d) instrument development involving input from a range of PRO measure development and CS experts. The resulting draft instrument underwent cognitive interviews with 7 CS patients. Results: Forty-six CS sources were reviewed. Analysis of patient interviews produced 23 patient-reported symptoms. The most frequently endorsed physical symptoms were flushing, diarrhea, abdominal pain, fatigue, and food sensitivity/triggers. Seven priority CS emotional and functional themes were also identified by patients. Expert interviews revealed 12 unique priority symptoms - the most common being diarrhea, flushing, wheezing, edema, abdominal pain/cramping, fatigue, and 8 emotional and functional concerns. Through an iterative process of team and clinical collaborator meetings, data review, item reduction and measure revision, 24 items were selected for the draft symptom index representing symptoms, emotional concerns, global assessment of treatment side effects, and functional well-being. Cognitive interview results demonstrated strong content validity, including positive endorsement of item clarity (>86% across items), symptom relevance (>70% for most items), and overall measure content (86%). Conclusions: The FACT-CSI is a content-relevant, symptom-focused index reflecting the highest priority and clinically relevant symptoms and concerns of people with CS.

AB - Objective: To develop a symptom-focused index to evaluate representative symptoms, treatment side effects, and emotional and functional well-being of patients with carcinoid syndrome (CS). Methods: The development of the Functional Assessment of Cancer Therapy-Carcinoid Syndrome Symptom Index (FACT-CSI) followed US Food and Drug Administration guidelines for the development of patient-reported outcome (PRO) measures and involved the following: (a) literature review; (b) interviews with 14 CS patients; (c) interviews with 9 clinicians; and (d) instrument development involving input from a range of PRO measure development and CS experts. The resulting draft instrument underwent cognitive interviews with 7 CS patients. Results: Forty-six CS sources were reviewed. Analysis of patient interviews produced 23 patient-reported symptoms. The most frequently endorsed physical symptoms were flushing, diarrhea, abdominal pain, fatigue, and food sensitivity/triggers. Seven priority CS emotional and functional themes were also identified by patients. Expert interviews revealed 12 unique priority symptoms - the most common being diarrhea, flushing, wheezing, edema, abdominal pain/cramping, fatigue, and 8 emotional and functional concerns. Through an iterative process of team and clinical collaborator meetings, data review, item reduction and measure revision, 24 items were selected for the draft symptom index representing symptoms, emotional concerns, global assessment of treatment side effects, and functional well-being. Cognitive interview results demonstrated strong content validity, including positive endorsement of item clarity (>86% across items), symptom relevance (>70% for most items), and overall measure content (86%). Conclusions: The FACT-CSI is a content-relevant, symptom-focused index reflecting the highest priority and clinically relevant symptoms and concerns of people with CS.

KW - Carcinoid syndrome

KW - Measure development

KW - Priority symptoms

KW - Qualitative methods

KW - Symptom index

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Development of the Functional Assessment of Cancer Therapy-Carcinoid Syndrome Symptom Index

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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