Design and recruitment for retinoid skin cancer prevention (SKICAP) trials

Thomas E. Moon, Norman Levine, Brenda Cartmel, Jerry Bangert, Steve Rodney, Michael Schreiber, Yei Mei Peng, David S Alberts, Frank Meyskens, David Alberts

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

The retinoid skin cancer prevention (SKICAP) trials are a set of double- blind, randomized, placebo-controlled clinical trials. The SKICAP-actinic keratoses (AK) trial tests the hypothesis that daily supplementation of retinol (25,000 IU) for 5 years reduces the incidence of skin cancers in high-risk individuals, those with a history of greater than ten clinically or pathologically diagnosed AK and, at most, one prior pathologically confirmed cutaneous squamous cell carcinoma (SCC) or basal cell carcinoma (BCC). The SKICAP-SCC/BCC (S/B) trial tests the hypothesis that daily supplementation of retinol (25,000 IU) or 13-cis-retinoic acid (5 or 10 mg) for 3 years reduces skin cancer incidence in very high-risk individuals, those with a history of at least four pathologically confirmed SCCs or BCCs. Between 1984 and 1988, 2800 participants were enrolled at two clinics on the SKICAP-AK trial; and between 1985 and 1990, a total of 719 participants were enrolled at four clinics on the SKICAP-S/B trial. The initial recruitment strategy was referral by dermatologists, but low accrual necessitated the use of other strategies to achieve enrollment goals, which included involving additional clinics and using paid trial-specific advertisements in print and electronic media. Thirteen % of the SKICAP-AK participants and 36% of the SKICAP-S/B participants were enrolled through dermatologist referral, whereas paid advertisements resulted in enrollment of 87% of SKICAP-AK and 43% of SKICAP- S/B participants. A population-based skin cancer registry was used to identify and enroll the remaining 21% of the SKICAP-S/B participants. This communication describes the design of the trials, the strategies, results, and costs of recruitment, and baseline participant characteristics.

Original languageEnglish (US)
Pages (from-to)661-669
Number of pages9
JournalCancer Epidemiology Biomarkers and Prevention
Volume4
Issue number6
StatePublished - 1995

Fingerprint

Retinoids
Skin Neoplasms
Actinic Keratosis
Basal Cell Carcinoma
Vitamin A
Squamous Cell Carcinoma
Referral and Consultation
Isotretinoin
Incidence
Registries
Randomized Controlled Trials
Placebos

ASJC Scopus subject areas

  • Epidemiology
  • Oncology

Cite this

Moon, T. E., Levine, N., Cartmel, B., Bangert, J., Rodney, S., Schreiber, M., ... Alberts, D. (1995). Design and recruitment for retinoid skin cancer prevention (SKICAP) trials. Cancer Epidemiology Biomarkers and Prevention, 4(6), 661-669.

Design and recruitment for retinoid skin cancer prevention (SKICAP) trials. / Moon, Thomas E.; Levine, Norman; Cartmel, Brenda; Bangert, Jerry; Rodney, Steve; Schreiber, Michael; Peng, Yei Mei; Alberts, David S; Meyskens, Frank; Alberts, David.

In: Cancer Epidemiology Biomarkers and Prevention, Vol. 4, No. 6, 1995, p. 661-669.

Research output: Contribution to journalArticle

Moon, TE, Levine, N, Cartmel, B, Bangert, J, Rodney, S, Schreiber, M, Peng, YM, Alberts, DS, Meyskens, F & Alberts, D 1995, 'Design and recruitment for retinoid skin cancer prevention (SKICAP) trials', Cancer Epidemiology Biomarkers and Prevention, vol. 4, no. 6, pp. 661-669.
Moon TE, Levine N, Cartmel B, Bangert J, Rodney S, Schreiber M et al. Design and recruitment for retinoid skin cancer prevention (SKICAP) trials. Cancer Epidemiology Biomarkers and Prevention. 1995;4(6):661-669.
Moon, Thomas E. ; Levine, Norman ; Cartmel, Brenda ; Bangert, Jerry ; Rodney, Steve ; Schreiber, Michael ; Peng, Yei Mei ; Alberts, David S ; Meyskens, Frank ; Alberts, David. / Design and recruitment for retinoid skin cancer prevention (SKICAP) trials. In: Cancer Epidemiology Biomarkers and Prevention. 1995 ; Vol. 4, No. 6. pp. 661-669.
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