Crew, K. D., Anderson, G. L., Arnold, K. B., Stieb, A. P., Amenta, J. N., Collins, N., Law, C. W., Pruthi, S., Sandoval-Leon, A., Bertoni, D., Grosse Perdekamp, M. T., Colonna, S., Krisher, S., King, T., Yee, L. D., Ballinger, T. J., Braun-Inglis, C., Mangino, D., Wisinski, K. B., ... Kukafka, R. (2024). Making informed choices on incorporating chemoprevention into carE (MiCHOICE, SWOG 1904): Design and methods of a cluster randomized controlled trial. Contemporary Clinical Trials, 142, Article 107564. https://doi.org/10.1016/j.cct.2024.107564
Crew, KD, Anderson, GL, Arnold, KB, Stieb, AP, Amenta, JN, Collins, N, Law, CW, Pruthi, S, Sandoval-Leon, A, Bertoni, D, Grosse Perdekamp, MT, Colonna, S, Krisher, S, King, T, Yee, LD, Ballinger, TJ, Braun-Inglis, C, Mangino, D, Wisinski, KB, DeYoung, CA, Ross, M, Floyd, J, Kaster, A, Vander Walde, L, Saphner, T, Zarwan, C, Lo, S, Graham, C, Conlin, A, Yost, K, Agnese, D, Jernigan, C, Hershman, DL, Neuhouser, ML, Arun, B & Kukafka, R 2024, 'Making informed choices on incorporating chemoprevention into carE (MiCHOICE, SWOG 1904): Design and methods of a cluster randomized controlled trial', Contemporary Clinical Trials, vol. 142, 107564. https://doi.org/10.1016/j.cct.2024.107564
@article{a719c956de78490ab09758068f28f6e7,
title = "Making informed choices on incorporating chemoprevention into carE (MiCHOICE, SWOG 1904): Design and methods of a cluster randomized controlled trial",
abstract = "Introduction: Women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) have a significantly increased risk of breast cancer, which can be substantially reduced with antiestrogen therapy for chemoprevention. However, antiestrogen therapy for breast cancer risk reduction remains underutilized. Improving knowledge about breast cancer risk and chemoprevention among high-risk patients and their healthcare providers may enhance informed decision-making about this critical breast cancer risk reduction strategy. Methods/design: We are conducting a cluster randomized controlled trial to evaluate the effectiveness and implementation of patient and provider decision support tools to improve informed choice about chemoprevention among women with AH or LCIS. We have cluster randomized 26 sites across the U.S. through the SWOG Cancer Research Network. A total of 415 patients and 200 healthcare providers are being recruited. They are assigned to standard educational materials alone or combined with the web-based decision support tools. Patient-reported and clinical outcomes are assessed at baseline, after a follow-up visit at 6 months, and yearly for 5 years. The primary outcome is chemoprevention informed choice after the follow-up visit. Secondary endpoints include other patient-reported outcomes, such as chemoprevention knowledge, decision conflict and regret, and self-reported chemoprevention usage. Barriers and facilitators to implementing decision support into clinic workflow are assessed through patient and provider interviews at baseline and mid-implementation. Results/discussion: With this hybrid effectiveness/implementation study, we seek to evaluate if a multi-level intervention effectively promotes informed decision-making about chemoprevention and provide valuable insights on how the intervention is implemented in U.S. clinical settings.",
author = "Crew, {K. D.} and Anderson, {G. L.} and Arnold, {K. B.} and Stieb, {A. P.} and Amenta, {J. N.} and N. Collins and Law, {C. W.} and S. Pruthi and A. Sandoval-Leon and D. Bertoni and {Grosse Perdekamp}, {M. T.} and S. Colonna and S. Krisher and T. King and Yee, {L. D.} and Ballinger, {T. J.} and C. Braun-Inglis and D. Mangino and Wisinski, {K. B.} and DeYoung, {C. A.} and M. Ross and J. Floyd and A. Kaster and {Vander Walde}, L. and T. Saphner and C. Zarwan and S. Lo and C. Graham and A. Conlin and K. Yost and D. Agnese and C. Jernigan and Hershman, {D. L.} and Neuhouser, {M. L.} and B. Arun and R. Kukafka",
note = "Publisher Copyright: {\textcopyright} 2024 Elsevier Inc.",
year = "2024",
month = jul,
doi = "10.1016/j.cct.2024.107564",
language = "English",
volume = "142",
journal = "Contemporary Clinical Trials",
issn = "1551-7144",
publisher = "Elsevier Inc.",
}
TY - JOUR
T1 - Making informed choices on incorporating chemoprevention into carE (MiCHOICE, SWOG 1904)
T2 - Design and methods of a cluster randomized controlled trial
AU - Crew, K. D.
AU - Anderson, G. L.
AU - Arnold, K. B.
AU - Stieb, A. P.
AU - Amenta, J. N.
AU - Collins, N.
AU - Law, C. W.
AU - Pruthi, S.
AU - Sandoval-Leon, A.
AU - Bertoni, D.
AU - Grosse Perdekamp, M. T.
AU - Colonna, S.
AU - Krisher, S.
AU - King, T.
AU - Yee, L. D.
AU - Ballinger, T. J.
AU - Braun-Inglis, C.
AU - Mangino, D.
AU - Wisinski, K. B.
AU - DeYoung, C. A.
AU - Ross, M.
AU - Floyd, J.
AU - Kaster, A.
AU - Vander Walde, L.
AU - Saphner, T.
AU - Zarwan, C.
AU - Lo, S.
AU - Graham, C.
AU - Conlin, A.
AU - Yost, K.
AU - Agnese, D.
AU - Jernigan, C.
AU - Hershman, D. L.
AU - Neuhouser, M. L.
AU - Arun, B.
AU - Kukafka, R.
N1 - Publisher Copyright:
© 2024 Elsevier Inc.
PY - 2024/7
Y1 - 2024/7
N2 - Introduction: Women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) have a significantly increased risk of breast cancer, which can be substantially reduced with antiestrogen therapy for chemoprevention. However, antiestrogen therapy for breast cancer risk reduction remains underutilized. Improving knowledge about breast cancer risk and chemoprevention among high-risk patients and their healthcare providers may enhance informed decision-making about this critical breast cancer risk reduction strategy. Methods/design: We are conducting a cluster randomized controlled trial to evaluate the effectiveness and implementation of patient and provider decision support tools to improve informed choice about chemoprevention among women with AH or LCIS. We have cluster randomized 26 sites across the U.S. through the SWOG Cancer Research Network. A total of 415 patients and 200 healthcare providers are being recruited. They are assigned to standard educational materials alone or combined with the web-based decision support tools. Patient-reported and clinical outcomes are assessed at baseline, after a follow-up visit at 6 months, and yearly for 5 years. The primary outcome is chemoprevention informed choice after the follow-up visit. Secondary endpoints include other patient-reported outcomes, such as chemoprevention knowledge, decision conflict and regret, and self-reported chemoprevention usage. Barriers and facilitators to implementing decision support into clinic workflow are assessed through patient and provider interviews at baseline and mid-implementation. Results/discussion: With this hybrid effectiveness/implementation study, we seek to evaluate if a multi-level intervention effectively promotes informed decision-making about chemoprevention and provide valuable insights on how the intervention is implemented in U.S. clinical settings.
AB - Introduction: Women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) have a significantly increased risk of breast cancer, which can be substantially reduced with antiestrogen therapy for chemoprevention. However, antiestrogen therapy for breast cancer risk reduction remains underutilized. Improving knowledge about breast cancer risk and chemoprevention among high-risk patients and their healthcare providers may enhance informed decision-making about this critical breast cancer risk reduction strategy. Methods/design: We are conducting a cluster randomized controlled trial to evaluate the effectiveness and implementation of patient and provider decision support tools to improve informed choice about chemoprevention among women with AH or LCIS. We have cluster randomized 26 sites across the U.S. through the SWOG Cancer Research Network. A total of 415 patients and 200 healthcare providers are being recruited. They are assigned to standard educational materials alone or combined with the web-based decision support tools. Patient-reported and clinical outcomes are assessed at baseline, after a follow-up visit at 6 months, and yearly for 5 years. The primary outcome is chemoprevention informed choice after the follow-up visit. Secondary endpoints include other patient-reported outcomes, such as chemoprevention knowledge, decision conflict and regret, and self-reported chemoprevention usage. Barriers and facilitators to implementing decision support into clinic workflow are assessed through patient and provider interviews at baseline and mid-implementation. Results/discussion: With this hybrid effectiveness/implementation study, we seek to evaluate if a multi-level intervention effectively promotes informed decision-making about chemoprevention and provide valuable insights on how the intervention is implemented in U.S. clinical settings.
UR - http://www.scopus.com/inward/record.url?scp=85192798931&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85192798931&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2024.107564
DO - 10.1016/j.cct.2024.107564
M3 - Article
C2 - 38704119
AN - SCOPUS:85192798931
SN - 1551-7144
VL - 142
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 107564
ER -