Abstract
Background: The Prostate Cancer Prevention Trial (PCPT) was a 7-year randomized, double-blind, placebocontrolled trial of the efficacy of finasteride for the prevention of prostate cancer with a primary outcome of histologically determined prevalence of prostate cancer at the end of 7 years. Methods: A systematic modeling process using logistic regression identified factors available at year 6 that are associated with end-of-study (EOS) biopsy adherence at year 7, stratified by whether participants were ever prompted for a prostate biopsy by year 6. Final models were evaluated for discrimination. At year 6,13,590 men were available for analysis. Results: Participants were more likely to have the EOS biopsy if they were adherent to study visit schedules and procedures and/or were in good health (P < 0.01). Participants at larger sites and/or sites that received retention and adherence grants were also more likely to have the EOS biopsy (P < 0.05). Conclusions: Our results show good adherence to study requirements 1 year before the EOS biopsy was associated with greater odds that a participant would comply with the invasive EOS requirement. Impact: Monitoring adherence behaviors may identify participants at risk of nonadherence to more demanding study end points. Such information could help frame adherence intervention strategies in future trials.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1638-1648 |
| Number of pages | 11 |
| Journal | Cancer Epidemiology Biomarkers and Prevention |
| Volume | 23 |
| Issue number | 8 |
| DOIs | |
| State | Published - 2014 |
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ASJC Scopus subject areas
- Oncology
- Epidemiology
Cite this
Factors associated with adherence to an end-of-study biopsy : Lessons from the prostate cancer prevention trial (SWOG-coordinated intergroup study S9217). / Gritz, Ellen R.; Arnold, Kathryn B.; Moinpour, Carol M.; Burton-Chase, Allison M.; Tangen, Catherine M.; Probstfield, Jeffrey F.; See, William A.; Lieber, Michael M.; Caggiano, Vincent; Moody-Thomas, Sarah; Szczepanek, Connie; Ryan, Anne; Carlin, Susie; Hill, Shannon; Goodman, Phyllis J.; Padberg, Rose Mary; Minasian, Lori M.; Meyskens, Frank L.; Thompson, Ian M.
In: Cancer Epidemiology Biomarkers and Prevention, Vol. 23, No. 8, 2014, p. 1638-1648.Research output: Contribution to journal › Article
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TY - JOUR
T1 - Factors associated with adherence to an end-of-study biopsy
T2 - Lessons from the prostate cancer prevention trial (SWOG-coordinated intergroup study S9217)
AU - Gritz, Ellen R.
AU - Arnold, Kathryn B.
AU - Moinpour, Carol M.
AU - Burton-Chase, Allison M.
AU - Tangen, Catherine M.
AU - Probstfield, Jeffrey F.
AU - See, William A.
AU - Lieber, Michael M.
AU - Caggiano, Vincent
AU - Moody-Thomas, Sarah
AU - Szczepanek, Connie
AU - Ryan, Anne
AU - Carlin, Susie
AU - Hill, Shannon
AU - Goodman, Phyllis J.
AU - Padberg, Rose Mary
AU - Minasian, Lori M.
AU - Meyskens, Frank L.
AU - Thompson, Ian M.
PY - 2014
Y1 - 2014
N2 - Background: The Prostate Cancer Prevention Trial (PCPT) was a 7-year randomized, double-blind, placebocontrolled trial of the efficacy of finasteride for the prevention of prostate cancer with a primary outcome of histologically determined prevalence of prostate cancer at the end of 7 years. Methods: A systematic modeling process using logistic regression identified factors available at year 6 that are associated with end-of-study (EOS) biopsy adherence at year 7, stratified by whether participants were ever prompted for a prostate biopsy by year 6. Final models were evaluated for discrimination. At year 6,13,590 men were available for analysis. Results: Participants were more likely to have the EOS biopsy if they were adherent to study visit schedules and procedures and/or were in good health (P < 0.01). Participants at larger sites and/or sites that received retention and adherence grants were also more likely to have the EOS biopsy (P < 0.05). Conclusions: Our results show good adherence to study requirements 1 year before the EOS biopsy was associated with greater odds that a participant would comply with the invasive EOS requirement. Impact: Monitoring adherence behaviors may identify participants at risk of nonadherence to more demanding study end points. Such information could help frame adherence intervention strategies in future trials.
AB - Background: The Prostate Cancer Prevention Trial (PCPT) was a 7-year randomized, double-blind, placebocontrolled trial of the efficacy of finasteride for the prevention of prostate cancer with a primary outcome of histologically determined prevalence of prostate cancer at the end of 7 years. Methods: A systematic modeling process using logistic regression identified factors available at year 6 that are associated with end-of-study (EOS) biopsy adherence at year 7, stratified by whether participants were ever prompted for a prostate biopsy by year 6. Final models were evaluated for discrimination. At year 6,13,590 men were available for analysis. Results: Participants were more likely to have the EOS biopsy if they were adherent to study visit schedules and procedures and/or were in good health (P < 0.01). Participants at larger sites and/or sites that received retention and adherence grants were also more likely to have the EOS biopsy (P < 0.05). Conclusions: Our results show good adherence to study requirements 1 year before the EOS biopsy was associated with greater odds that a participant would comply with the invasive EOS requirement. Impact: Monitoring adherence behaviors may identify participants at risk of nonadherence to more demanding study end points. Such information could help frame adherence intervention strategies in future trials.
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U2 - 10.1158/1055-9965.EPI-14-0202
DO - 10.1158/1055-9965.EPI-14-0202
M3 - Article
C2 - 25028457
AN - SCOPUS:84905455445
VL - 23
SP - 1638
EP - 1648
JO - Cancer Epidemiology Biomarkers and Prevention
JF - Cancer Epidemiology Biomarkers and Prevention
SN - 1055-9965
IS - 8
ER -