Validation and comparison of quality-of-life measures for topical 5-fluorouracil treatment

results from a randomized controlled trial

the VA Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial Group*

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: Topical 5-fluorouracil (5-FU) is commonly used for high-risk patients with keratinocyte carcinoma (KC). Skindex and Skin Cancer Index (SCI) are validated instruments to measure quality of life (QoL) of patients with KC and those who have had surgical treatment of KCs. Aim: To validate Skindex and SCI for topical 5-fluorouracil (5-FU) application and to compare the two QoL instruments. Methods: We randomized 932 veterans at high risk for developing a KC to either topical 5-FU or vehicle control cream applied to the face and ears for up to 1 month. We collected their Skindex-29 and SCI scores at baseline and follow-up visits. Results: Compared with controls, 5-FU reduced QoL, measured by the Skindex symptom, Skindex function and SCI social subscales (P < 0.001, P < 0.01, P = 0.02, respectively). At 1 month, significant changes in QoL in the 5-FU group were observed in the Skindex symptom (10.1, 95% CI 0.36–12.6), Skindex function (6.0, 95% CI 4.0–8.0) and SCI social (−3.5, 95% CI −6.2 to −0.8) subscales, while the other subscales of Skindex and SCI did not show significant changes. All three Skindex subscales at 1 month correlated with patient-reported symptom score and photograph-based toxicity score, whereas social subscale was the only one of the SCI subscales that correlated with patient-reported symptom and photograph-based toxicity scores. Conclusions: Our study validated Skindex symptom, Skindex function and SCI social subscales for QoL measurement during treatment with topical 5-FU. The study could not provide evidence for construct validity of the other subscales. Skindex was more responsive than SCI in the context of 5-FU treatment.

Original languageEnglish (US)
Pages (from-to)488-495
Number of pages8
JournalClinical and Experimental Dermatology
Volume42
Issue number5
DOIs
StatePublished - Jul 1 2017

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Skin Neoplasms
Fluorouracil
Randomized Controlled Trials
Quality of Life
Keratinocytes
Therapeutics
Carcinoma
Veterans
Ear

ASJC Scopus subject areas

  • Dermatology

Cite this

Validation and comparison of quality-of-life measures for topical 5-fluorouracil treatment : results from a randomized controlled trial. / the VA Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial Group*.

In: Clinical and Experimental Dermatology, Vol. 42, No. 5, 01.07.2017, p. 488-495.

Research output: Contribution to journalArticle

@article{0e6f93abd6574fe8988d782e03939c3d,
title = "Validation and comparison of quality-of-life measures for topical 5-fluorouracil treatment: results from a randomized controlled trial",
abstract = "Background: Topical 5-fluorouracil (5-FU) is commonly used for high-risk patients with keratinocyte carcinoma (KC). Skindex and Skin Cancer Index (SCI) are validated instruments to measure quality of life (QoL) of patients with KC and those who have had surgical treatment of KCs. Aim: To validate Skindex and SCI for topical 5-fluorouracil (5-FU) application and to compare the two QoL instruments. Methods: We randomized 932 veterans at high risk for developing a KC to either topical 5-FU or vehicle control cream applied to the face and ears for up to 1 month. We collected their Skindex-29 and SCI scores at baseline and follow-up visits. Results: Compared with controls, 5-FU reduced QoL, measured by the Skindex symptom, Skindex function and SCI social subscales (P < 0.001, P < 0.01, P = 0.02, respectively). At 1 month, significant changes in QoL in the 5-FU group were observed in the Skindex symptom (10.1, 95{\%} CI 0.36–12.6), Skindex function (6.0, 95{\%} CI 4.0–8.0) and SCI social (−3.5, 95{\%} CI −6.2 to −0.8) subscales, while the other subscales of Skindex and SCI did not show significant changes. All three Skindex subscales at 1 month correlated with patient-reported symptom score and photograph-based toxicity score, whereas social subscale was the only one of the SCI subscales that correlated with patient-reported symptom and photograph-based toxicity scores. Conclusions: Our study validated Skindex symptom, Skindex function and SCI social subscales for QoL measurement during treatment with topical 5-FU. The study could not provide evidence for construct validity of the other subscales. Skindex was more responsive than SCI in the context of 5-FU treatment.",
author = "{the VA Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial Group*} and H. Pomerantz and Chren, {M. M.} and R. Lew and Weinstock, {M. A.} and Chen, {S. C.} and Dellavalle, {R. P.} and Warshaw, {E. M.} and DiGiovanna, {J. J.} and R. Ferguson and R. Ringer and J. Yoon and Phibbs, {C. S.} and K. Kraemer and D. Hogan and D. Eilers and S. Swetter and Chen, {S. C.} and S. Jacob and Warshaw, {E. M.} and G. Stricklin and Dellavalle, {R. P.} and N. Konnikov and V. Werth and N. Sidhu-Malik and Jonette Keri and Swan, {J. W.} and K. Nord and B. Pollack and S. Kempiak and W. High and N. Fett and Hall, {Rl P.} and Alonso-Llamazares, {J. R.} and G. Rodriguez and L. Sisler and M. O'Sullivan and S. Wilson and M. Agrawal and D. Bartenfeld and K. Nicalo and D. Johnson and P. Parks and B. Bidek and N. Boyd and B. Watson and D. Wolfe and M. Zacheis and J. Okawa and Iannacchione, {M. A.} and J. Quintero",
year = "2017",
month = "7",
day = "1",
doi = "10.1111/ced.13089",
language = "English (US)",
volume = "42",
pages = "488--495",
journal = "Clinical and Experimental Dermatology",
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TY - JOUR

T1 - Validation and comparison of quality-of-life measures for topical 5-fluorouracil treatment

T2 - results from a randomized controlled trial

AU - the VA Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial Group

AU - Pomerantz, H.

AU - Chren, M. M.

AU - Lew, R.

AU - Weinstock, M. A.

AU - Chen, S. C.

AU - Dellavalle, R. P.

AU - Warshaw, E. M.

AU - DiGiovanna, J. J.

AU - Ferguson, R.

AU - Ringer, R.

AU - Yoon, J.

AU - Phibbs, C. S.

AU - Kraemer, K.

AU - Hogan, D.

AU - Eilers, D.

AU - Swetter, S.

AU - Chen, S. C.

AU - Jacob, S.

AU - Warshaw, E. M.

AU - Stricklin, G.

AU - Dellavalle, R. P.

AU - Konnikov, N.

AU - Werth, V.

AU - Sidhu-Malik, N.

AU - Keri, Jonette

AU - Swan, J. W.

AU - Nord, K.

AU - Pollack, B.

AU - Kempiak, S.

AU - High, W.

AU - Fett, N.

AU - Hall, Rl P.

AU - Alonso-Llamazares, J. R.

AU - Rodriguez, G.

AU - Sisler, L.

AU - O'Sullivan, M.

AU - Wilson, S.

AU - Agrawal, M.

AU - Bartenfeld, D.

AU - Nicalo, K.

AU - Johnson, D.

AU - Parks, P.

AU - Bidek, B.

AU - Boyd, N.

AU - Watson, B.

AU - Wolfe, D.

AU - Zacheis, M.

AU - Okawa, J.

AU - Iannacchione, M. A.

AU - Quintero, J.

PY - 2017/7/1

Y1 - 2017/7/1

N2 - Background: Topical 5-fluorouracil (5-FU) is commonly used for high-risk patients with keratinocyte carcinoma (KC). Skindex and Skin Cancer Index (SCI) are validated instruments to measure quality of life (QoL) of patients with KC and those who have had surgical treatment of KCs. Aim: To validate Skindex and SCI for topical 5-fluorouracil (5-FU) application and to compare the two QoL instruments. Methods: We randomized 932 veterans at high risk for developing a KC to either topical 5-FU or vehicle control cream applied to the face and ears for up to 1 month. We collected their Skindex-29 and SCI scores at baseline and follow-up visits. Results: Compared with controls, 5-FU reduced QoL, measured by the Skindex symptom, Skindex function and SCI social subscales (P < 0.001, P < 0.01, P = 0.02, respectively). At 1 month, significant changes in QoL in the 5-FU group were observed in the Skindex symptom (10.1, 95% CI 0.36–12.6), Skindex function (6.0, 95% CI 4.0–8.0) and SCI social (−3.5, 95% CI −6.2 to −0.8) subscales, while the other subscales of Skindex and SCI did not show significant changes. All three Skindex subscales at 1 month correlated with patient-reported symptom score and photograph-based toxicity score, whereas social subscale was the only one of the SCI subscales that correlated with patient-reported symptom and photograph-based toxicity scores. Conclusions: Our study validated Skindex symptom, Skindex function and SCI social subscales for QoL measurement during treatment with topical 5-FU. The study could not provide evidence for construct validity of the other subscales. Skindex was more responsive than SCI in the context of 5-FU treatment.

AB - Background: Topical 5-fluorouracil (5-FU) is commonly used for high-risk patients with keratinocyte carcinoma (KC). Skindex and Skin Cancer Index (SCI) are validated instruments to measure quality of life (QoL) of patients with KC and those who have had surgical treatment of KCs. Aim: To validate Skindex and SCI for topical 5-fluorouracil (5-FU) application and to compare the two QoL instruments. Methods: We randomized 932 veterans at high risk for developing a KC to either topical 5-FU or vehicle control cream applied to the face and ears for up to 1 month. We collected their Skindex-29 and SCI scores at baseline and follow-up visits. Results: Compared with controls, 5-FU reduced QoL, measured by the Skindex symptom, Skindex function and SCI social subscales (P < 0.001, P < 0.01, P = 0.02, respectively). At 1 month, significant changes in QoL in the 5-FU group were observed in the Skindex symptom (10.1, 95% CI 0.36–12.6), Skindex function (6.0, 95% CI 4.0–8.0) and SCI social (−3.5, 95% CI −6.2 to −0.8) subscales, while the other subscales of Skindex and SCI did not show significant changes. All three Skindex subscales at 1 month correlated with patient-reported symptom score and photograph-based toxicity score, whereas social subscale was the only one of the SCI subscales that correlated with patient-reported symptom and photograph-based toxicity scores. Conclusions: Our study validated Skindex symptom, Skindex function and SCI social subscales for QoL measurement during treatment with topical 5-FU. The study could not provide evidence for construct validity of the other subscales. Skindex was more responsive than SCI in the context of 5-FU treatment.

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U2 - 10.1111/ced.13089

DO - 10.1111/ced.13089

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