Abstract
The development and current widespread acceptance of clinical trials is one of the major conceptual advances in research medicine introduced during the second half of the 20th century. Despite general agreement on the scientific merits of randomization, many patients and physicians are however reluctant to participate in randomized, controlled trials. If we focus on chemoprevention in healthy subjects, it is even more essential to evaluate the ethics, logistics, patient's and doctor's acceptability, acute and late toxic effect, patient accrual and compliance of treatment. Furthermore, the decision-making process about participating in a cancer chemoprevention trial is often poorly understood. Adherence to a cancer prevention trial requires in fact a strong sense of awareness and an ability to carefully assess risks and benefits. We review the main aspects in the chemo-preventive approach to patients at high risk for breast and ovarian cancer, focusing on different pharmacological risk reduction strategies, ongoing phase III chemoprevention studies in carriers of BRCA1/2 germline mutation, the psychological and clinical factors implicated in decision making about a trial, and the possible impact of the trial design on the overall acceptability and adherence.
| Original language | English |
|---|---|
| Article number | mdt328 |
| Journal | Annals of Oncology |
| Volume | 24 |
| Issue number | SUPPL.B |
| DOIs | |
| Publication status | Published - 2013 |
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Keywords
- BRCA mutations
- Chemoprevention
- Clinical trials
- Ethics
- Patient adherence
ASJC Scopus subject areas
- Oncology
- Hematology
Cite this
Acceptability of chemoprevention trials in high-risk subjects. / Bonanni, B.; Lazzeroni, M.
In: Annals of Oncology, Vol. 24, No. SUPPL.B, mdt328, 2013.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Acceptability of chemoprevention trials in high-risk subjects
AU - Bonanni, B.
AU - Lazzeroni, M.
PY - 2013
Y1 - 2013
N2 - The development and current widespread acceptance of clinical trials is one of the major conceptual advances in research medicine introduced during the second half of the 20th century. Despite general agreement on the scientific merits of randomization, many patients and physicians are however reluctant to participate in randomized, controlled trials. If we focus on chemoprevention in healthy subjects, it is even more essential to evaluate the ethics, logistics, patient's and doctor's acceptability, acute and late toxic effect, patient accrual and compliance of treatment. Furthermore, the decision-making process about participating in a cancer chemoprevention trial is often poorly understood. Adherence to a cancer prevention trial requires in fact a strong sense of awareness and an ability to carefully assess risks and benefits. We review the main aspects in the chemo-preventive approach to patients at high risk for breast and ovarian cancer, focusing on different pharmacological risk reduction strategies, ongoing phase III chemoprevention studies in carriers of BRCA1/2 germline mutation, the psychological and clinical factors implicated in decision making about a trial, and the possible impact of the trial design on the overall acceptability and adherence.
AB - The development and current widespread acceptance of clinical trials is one of the major conceptual advances in research medicine introduced during the second half of the 20th century. Despite general agreement on the scientific merits of randomization, many patients and physicians are however reluctant to participate in randomized, controlled trials. If we focus on chemoprevention in healthy subjects, it is even more essential to evaluate the ethics, logistics, patient's and doctor's acceptability, acute and late toxic effect, patient accrual and compliance of treatment. Furthermore, the decision-making process about participating in a cancer chemoprevention trial is often poorly understood. Adherence to a cancer prevention trial requires in fact a strong sense of awareness and an ability to carefully assess risks and benefits. We review the main aspects in the chemo-preventive approach to patients at high risk for breast and ovarian cancer, focusing on different pharmacological risk reduction strategies, ongoing phase III chemoprevention studies in carriers of BRCA1/2 germline mutation, the psychological and clinical factors implicated in decision making about a trial, and the possible impact of the trial design on the overall acceptability and adherence.
KW - BRCA mutations
KW - Chemoprevention
KW - Clinical trials
KW - Ethics
KW - Patient adherence
UR - http://www.scopus.com/inward/record.url?scp=84886283213&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84886283213&partnerID=8YFLogxK
U2 - 10.1093/annonc/mdt328
DO - 10.1093/annonc/mdt328
M3 - Article
C2 - 24131969
AN - SCOPUS:84886283213
VL - 24
JO - Annals of Oncology
JF - Annals of Oncology
SN - 0923-7534
IS - SUPPL.B
M1 - mdt328
ER -