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Validation and comparison of quality-of-life measures for topical 5-fluorouracil treatment: results from a randomized controlled trial.

Publication ,  Journal Article
Pomerantz, H; Chren, M-M; Lew, R; Weinstock, MA; VA Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial Group*,
Published in: Clin Exp Dermatol
July 2017

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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Published In

Clin Exp Dermatol

DOI

EISSN

1365-2230

Publication Date

July 2017

Volume

42

Issue

5

Start / End Page

488 / 495

Location

England

Related Subject Headings

  • Veterans
  • Surveys and Questionnaires
  • Skin Neoplasms
  • Quality of Life
  • Male
  • Humans
  • Fluorouracil
  • Female
  • Dermatology & Venereal Diseases
  • Analysis of Variance
 

Citation

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Chicago
ICMJE
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Pomerantz, H., Chren, M.-M., Lew, R., Weinstock, M. A., & VA Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial Group*, . (2017). Validation and comparison of quality-of-life measures for topical 5-fluorouracil treatment: results from a randomized controlled trial. Clin Exp Dermatol, 42(5), 488–495. https://doi.org/10.1111/ced.13089
Pomerantz, H., M. -. M. Chren, R. Lew, M. A. Weinstock, and M. A. VA Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial Group*. “Validation and comparison of quality-of-life measures for topical 5-fluorouracil treatment: results from a randomized controlled trial.Clin Exp Dermatol 42, no. 5 (July 2017): 488–95. https://doi.org/10.1111/ced.13089.
Pomerantz H, Chren M-M, Lew R, Weinstock MA, VA Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial Group*. Validation and comparison of quality-of-life measures for topical 5-fluorouracil treatment: results from a randomized controlled trial. Clin Exp Dermatol. 2017 Jul;42(5):488–95.
Pomerantz, H., et al. “Validation and comparison of quality-of-life measures for topical 5-fluorouracil treatment: results from a randomized controlled trial.Clin Exp Dermatol, vol. 42, no. 5, July 2017, pp. 488–95. Pubmed, doi:10.1111/ced.13089.
Pomerantz H, Chren M-M, Lew R, Weinstock MA, VA Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial Group*. Validation and comparison of quality-of-life measures for topical 5-fluorouracil treatment: results from a randomized controlled trial. Clin Exp Dermatol. 2017 Jul;42(5):488–495.
Journal cover image

Published In

Clin Exp Dermatol

DOI

EISSN

1365-2230

Publication Date

July 2017

Volume

42

Issue

5

Start / End Page

488 / 495

Location

England

Related Subject Headings

  • Veterans
  • Surveys and Questionnaires
  • Skin Neoplasms
  • Quality of Life
  • Male
  • Humans
  • Fluorouracil
  • Female
  • Dermatology & Venereal Diseases
  • Analysis of Variance