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 language | English (US) |
|---|---|
| Pages (from-to) | 661-669 |
| Number of pages | 9 |
| Journal | Cancer Epidemiology Biomarkers and Prevention |
| Volume | 4 |
| Issue number | 6 |
| State | Published - 1995 |
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ASJC Scopus subject areas
- Epidemiology
- Oncology
Cite this
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 journal › Article
}
TY - JOUR
T1 - Design and recruitment for retinoid skin cancer prevention (SKICAP) trials
AU - Moon, Thomas E.
AU - Levine, Norman
AU - Cartmel, Brenda
AU - Bangert, Jerry
AU - Rodney, Steve
AU - Schreiber, Michael
AU - Peng, Yei Mei
AU - Alberts, David S
AU - Meyskens, Frank
AU - Alberts, David
PY - 1995
Y1 - 1995
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=0029160550&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0029160550&partnerID=8YFLogxK
M3 - Article
C2 - 8547834
AN - SCOPUS:0029160550
VL - 4
SP - 661
EP - 669
JO - Cancer Epidemiology Biomarkers and Prevention
JF - Cancer Epidemiology Biomarkers and Prevention
SN - 1055-9965
IS - 6
ER -