Meaningful differences and validity for the NCCN/FACT-P symptom index

An analysis of the ALSYMPCA data

Jennifer L. Beaumont, Zeeshan Butt, Rui Li, David Cella*

*Corresponding author for this work

Research output: Contribution to journalArticle

Abstract

Background: The Functional Assessment of Cancer Therapy–Prostate (FACT-P) and the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy–Prostate Symptom Index-17 (NFPSI-17) are 2 commonly used measures for patient-reported outcomes in prostate cancer trials. Their use may be enhanced by a better understanding of how change scores on the measures should be interpreted. Methods: Using data from the phase 3 Alpharadin in Symptomatic Prostate Cancer Patients trial, this study estimated important change scores on the FACT-P and the NFPSI-17 via a combination of distribution- and anchor-based methods. These data were also used to establish evidence for the validity of the NFPSI-17. Results: The available data suggested the following important difference ranges: 2 to 4 points for the Prostate Cancer Subscale, 5.5 to 8.5 points for the Trial Outcome Index, 1 to 1.5 points for the 3-item Pain Scale, 1 to 2 points for the 4-item Pain Scale, 4 to 6 points for the NFPSI-17, 2 to 3.5 points for NFPSI–Disease-Related Symptoms–Physical, 0.5 points for NFPSI–Disease-Related Symptoms–Emotional, 1 to 1.5 points for NFPSI–Treatment Side Effects, and 0.5 to 1 point for NFPSI–Function/Well-Being. The internal consistency reliability of the NFPSI-17 and most of its subscales was good to excellent (>.70). Significant support was also found for the known groups validity of the NFPSI-17 (and most of its subscales) on the basis of the Eastern Cooperative Oncology Group performance status, the total alkaline phosphatase, the presence of a skeletal-related event during treatment, and the prostate-specific antigen response before the end of treatment. Conclusions: The secondary analysis supports the continued use of the FACT-P, the NFPSI-17, and its related subscales in future research on the quality of life of patients with symptomatic castration-resistant prostate cancer with bone metastases.

Original languageEnglish (US)
JournalCancer
DOIs
StatePublished - Jan 1 2019

Fingerprint

Neoplasms
Prostatic Neoplasms
Pain
Bone Neoplasms
Castration
Prostate-Specific Antigen
Alkaline Phosphatase
Quality of Life
Neoplasm Metastasis
Therapeutics

Keywords

  • cancer
  • health services
  • patient-reported outcome measure
  • prostate
  • quality of life

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

@article{9e0a041956e447a3b891e3ced12fce9f,
title = "Meaningful differences and validity for the NCCN/FACT-P symptom index: An analysis of the ALSYMPCA data",
abstract = "Background: The Functional Assessment of Cancer Therapy–Prostate (FACT-P) and the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy–Prostate Symptom Index-17 (NFPSI-17) are 2 commonly used measures for patient-reported outcomes in prostate cancer trials. Their use may be enhanced by a better understanding of how change scores on the measures should be interpreted. Methods: Using data from the phase 3 Alpharadin in Symptomatic Prostate Cancer Patients trial, this study estimated important change scores on the FACT-P and the NFPSI-17 via a combination of distribution- and anchor-based methods. These data were also used to establish evidence for the validity of the NFPSI-17. Results: The available data suggested the following important difference ranges: 2 to 4 points for the Prostate Cancer Subscale, 5.5 to 8.5 points for the Trial Outcome Index, 1 to 1.5 points for the 3-item Pain Scale, 1 to 2 points for the 4-item Pain Scale, 4 to 6 points for the NFPSI-17, 2 to 3.5 points for NFPSI–Disease-Related Symptoms–Physical, 0.5 points for NFPSI–Disease-Related Symptoms–Emotional, 1 to 1.5 points for NFPSI–Treatment Side Effects, and 0.5 to 1 point for NFPSI–Function/Well-Being. The internal consistency reliability of the NFPSI-17 and most of its subscales was good to excellent (>.70). Significant support was also found for the known groups validity of the NFPSI-17 (and most of its subscales) on the basis of the Eastern Cooperative Oncology Group performance status, the total alkaline phosphatase, the presence of a skeletal-related event during treatment, and the prostate-specific antigen response before the end of treatment. Conclusions: The secondary analysis supports the continued use of the FACT-P, the NFPSI-17, and its related subscales in future research on the quality of life of patients with symptomatic castration-resistant prostate cancer with bone metastases.",
keywords = "cancer, health services, patient-reported outcome measure, prostate, quality of life",
author = "Beaumont, {Jennifer L.} and Zeeshan Butt and Rui Li and David Cella",
year = "2019",
month = "1",
day = "1",
doi = "10.1002/cncr.31973",
language = "English (US)",
journal = "Cancer",
issn = "0008-543X",
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}

Meaningful differences and validity for the NCCN/FACT-P symptom index : An analysis of the ALSYMPCA data. / Beaumont, Jennifer L.; Butt, Zeeshan; Li, Rui; Cella, David.

In: Cancer, 01.01.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Meaningful differences and validity for the NCCN/FACT-P symptom index

T2 - An analysis of the ALSYMPCA data

AU - Beaumont, Jennifer L.

AU - Butt, Zeeshan

AU - Li, Rui

AU - Cella, David

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: The Functional Assessment of Cancer Therapy–Prostate (FACT-P) and the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy–Prostate Symptom Index-17 (NFPSI-17) are 2 commonly used measures for patient-reported outcomes in prostate cancer trials. Their use may be enhanced by a better understanding of how change scores on the measures should be interpreted. Methods: Using data from the phase 3 Alpharadin in Symptomatic Prostate Cancer Patients trial, this study estimated important change scores on the FACT-P and the NFPSI-17 via a combination of distribution- and anchor-based methods. These data were also used to establish evidence for the validity of the NFPSI-17. Results: The available data suggested the following important difference ranges: 2 to 4 points for the Prostate Cancer Subscale, 5.5 to 8.5 points for the Trial Outcome Index, 1 to 1.5 points for the 3-item Pain Scale, 1 to 2 points for the 4-item Pain Scale, 4 to 6 points for the NFPSI-17, 2 to 3.5 points for NFPSI–Disease-Related Symptoms–Physical, 0.5 points for NFPSI–Disease-Related Symptoms–Emotional, 1 to 1.5 points for NFPSI–Treatment Side Effects, and 0.5 to 1 point for NFPSI–Function/Well-Being. The internal consistency reliability of the NFPSI-17 and most of its subscales was good to excellent (>.70). Significant support was also found for the known groups validity of the NFPSI-17 (and most of its subscales) on the basis of the Eastern Cooperative Oncology Group performance status, the total alkaline phosphatase, the presence of a skeletal-related event during treatment, and the prostate-specific antigen response before the end of treatment. Conclusions: The secondary analysis supports the continued use of the FACT-P, the NFPSI-17, and its related subscales in future research on the quality of life of patients with symptomatic castration-resistant prostate cancer with bone metastases.

AB - Background: The Functional Assessment of Cancer Therapy–Prostate (FACT-P) and the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy–Prostate Symptom Index-17 (NFPSI-17) are 2 commonly used measures for patient-reported outcomes in prostate cancer trials. Their use may be enhanced by a better understanding of how change scores on the measures should be interpreted. Methods: Using data from the phase 3 Alpharadin in Symptomatic Prostate Cancer Patients trial, this study estimated important change scores on the FACT-P and the NFPSI-17 via a combination of distribution- and anchor-based methods. These data were also used to establish evidence for the validity of the NFPSI-17. Results: The available data suggested the following important difference ranges: 2 to 4 points for the Prostate Cancer Subscale, 5.5 to 8.5 points for the Trial Outcome Index, 1 to 1.5 points for the 3-item Pain Scale, 1 to 2 points for the 4-item Pain Scale, 4 to 6 points for the NFPSI-17, 2 to 3.5 points for NFPSI–Disease-Related Symptoms–Physical, 0.5 points for NFPSI–Disease-Related Symptoms–Emotional, 1 to 1.5 points for NFPSI–Treatment Side Effects, and 0.5 to 1 point for NFPSI–Function/Well-Being. The internal consistency reliability of the NFPSI-17 and most of its subscales was good to excellent (>.70). Significant support was also found for the known groups validity of the NFPSI-17 (and most of its subscales) on the basis of the Eastern Cooperative Oncology Group performance status, the total alkaline phosphatase, the presence of a skeletal-related event during treatment, and the prostate-specific antigen response before the end of treatment. Conclusions: The secondary analysis supports the continued use of the FACT-P, the NFPSI-17, and its related subscales in future research on the quality of life of patients with symptomatic castration-resistant prostate cancer with bone metastases.

KW - cancer

KW - health services

KW - patient-reported outcome measure

KW - prostate

KW - quality of life

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DO - 10.1002/cncr.31973

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