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Decision-making and breast cancer clinical trials How experience challenges attitudes
The aim of this study was to measure women's preferences about decision-making and their impact to participate or not to a hypothetical randomised controlled trial (RCT). We surveyed prospectively breast cancer patients invited to participate in a clinical RCT (group 1a=201 acceptances, group 1...
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| Published in: | Contemporary clinical trials 2007-11, Vol.28 (6), p.684-694 |
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| Main Authors: | , , , , , , , , , , , , |
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| container_title | Contemporary clinical trials |
| container_volume | 28 |
| creator | MANCINI, Julien GENEVE, Jean JIMENEZ, Marta TARPIN, Carole REYNIER, Claire Julian DALENC, Florence GENRE, Dominique MONNIER, Alain KERBRAT, Pierre LARGILLIER, Rémy SERIN, Daniel RIOS, Maria ROCHE, Henri |
| description | The aim of this study was to measure women's preferences about decision-making and their impact to participate or not to a hypothetical randomised controlled trial (RCT).
We surveyed prospectively breast cancer patients invited to participate in a clinical RCT (group 1a=201 acceptances, group 1b=66 refusals) or not invited (group 2=188). All women had the same treatment.
Decision-making preferences of patients who had refused clinical RCT entry were more patient's centred (72.3%) compared to those of patients who accepted (35.0%, P |
| doi_str_mv | 10.1016/j.cct.2007.03.001 |
| format | article |
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We surveyed prospectively breast cancer patients invited to participate in a clinical RCT (group 1a=201 acceptances, group 1b=66 refusals) or not invited (group 2=188). All women had the same treatment.
Decision-making preferences of patients who had refused clinical RCT entry were more patient's centred (72.3%) compared to those of patients who accepted (35.0%, P<0.001). Altruism was not a significant determinant of patients' participation. Randomisation was considered acceptable in 52.0% (group 1a) compared to 16.9% and 21.1% for group 1b or group 2, respectively (P<0.001). It was the main predictor of willingness to participate in a hypothetical RCT (adjusted odds ratio (OR(adj)) 4.6; 95% confidence interval [2.7-7.7]; P<0.001) with the patient group allocation (OR(adj) group 1a=5.0 [2.9-8.7]; group 1b=0.2 [0.0-0.8]; group 2=1 [referent]; P<0.001). After multivariate adjustment, willingness to participate was also significantly related with medical decision-making preferences (OR(adj) 2.2 [1.0-4.9]; P=0.045), with the feeling of being unable to refuse a doctor's proposal (OR(adj) 1.8 [1.1-3.2]; P=0.031), and with satisfaction with doctors' communication (OR(adj) 3.1 [1.5-7.8]; P<0.001).
Patients' acceptance to participate in a RCT is preferred to be doctor's decision, whereas refusal is a personal one. When proposing a RCT, doctors must deal with patients' a priori negative feelings about randomisation. They should thoroughly discuss the reasons for and importance of randomisation as well as the other aspects of participating in the trial in order to give patients all of the information they need to make an informed decision.</description><identifier>ISSN: 1551-7144</identifier><identifier>EISSN: 1559-2030</identifier><identifier>DOI: 10.1016/j.cct.2007.03.001</identifier><identifier>PMID: 17434812</identifier><language>eng</language><publisher>New York, NY: Elsevier</publisher><subject>Adult ; Attitude ; Biological and medical sciences ; Breast Neoplasms ; Clinical trial. Drug monitoring ; Clinical Trials as Topic ; Decision Making ; Female ; France ; General pharmacology ; Gynecology. Andrology. Obstetrics ; Health Care Surveys ; Humans ; Mammary gland diseases ; Medical sciences ; Middle Aged ; Patient Participation - psychology ; Pharmacology. Drug treatments ; Prospective Studies ; Randomized Controlled Trials as Topic ; Tumors</subject><ispartof>Contemporary clinical trials, 2007-11, Vol.28 (6), p.684-694</ispartof><rights>2007 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27923,27924</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=19158810$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17434812$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>MANCINI, Julien</creatorcontrib><creatorcontrib>GENEVE, Jean</creatorcontrib><creatorcontrib>JIMENEZ, Marta</creatorcontrib><creatorcontrib>TARPIN, Carole</creatorcontrib><creatorcontrib>REYNIER, Claire Julian</creatorcontrib><creatorcontrib>DALENC, Florence</creatorcontrib><creatorcontrib>GENRE, Dominique</creatorcontrib><creatorcontrib>MONNIER, Alain</creatorcontrib><creatorcontrib>KERBRAT, Pierre</creatorcontrib><creatorcontrib>LARGILLIER, Rémy</creatorcontrib><creatorcontrib>SERIN, Daniel</creatorcontrib><creatorcontrib>RIOS, Maria</creatorcontrib><creatorcontrib>ROCHE, Henri</creatorcontrib><creatorcontrib>Patients' Committee for Clinical Trials of the Ligue Nationale</creatorcontrib><title>Decision-making and breast cancer clinical trials How experience challenges attitudes</title><title>Contemporary clinical trials</title><addtitle>Contemp Clin Trials</addtitle><description>The aim of this study was to measure women's preferences about decision-making and their impact to participate or not to a hypothetical randomised controlled trial (RCT).
We surveyed prospectively breast cancer patients invited to participate in a clinical RCT (group 1a=201 acceptances, group 1b=66 refusals) or not invited (group 2=188). All women had the same treatment.
Decision-making preferences of patients who had refused clinical RCT entry were more patient's centred (72.3%) compared to those of patients who accepted (35.0%, P<0.001). Altruism was not a significant determinant of patients' participation. Randomisation was considered acceptable in 52.0% (group 1a) compared to 16.9% and 21.1% for group 1b or group 2, respectively (P<0.001). It was the main predictor of willingness to participate in a hypothetical RCT (adjusted odds ratio (OR(adj)) 4.6; 95% confidence interval [2.7-7.7]; P<0.001) with the patient group allocation (OR(adj) group 1a=5.0 [2.9-8.7]; group 1b=0.2 [0.0-0.8]; group 2=1 [referent]; P<0.001). After multivariate adjustment, willingness to participate was also significantly related with medical decision-making preferences (OR(adj) 2.2 [1.0-4.9]; P=0.045), with the feeling of being unable to refuse a doctor's proposal (OR(adj) 1.8 [1.1-3.2]; P=0.031), and with satisfaction with doctors' communication (OR(adj) 3.1 [1.5-7.8]; P<0.001).
Patients' acceptance to participate in a RCT is preferred to be doctor's decision, whereas refusal is a personal one. When proposing a RCT, doctors must deal with patients' a priori negative feelings about randomisation. They should thoroughly discuss the reasons for and importance of randomisation as well as the other aspects of participating in the trial in order to give patients all of the information they need to make an informed decision.</description><subject>Adult</subject><subject>Attitude</subject><subject>Biological and medical sciences</subject><subject>Breast Neoplasms</subject><subject>Clinical trial. Drug monitoring</subject><subject>Clinical Trials as Topic</subject><subject>Decision Making</subject><subject>Female</subject><subject>France</subject><subject>General pharmacology</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Health Care Surveys</subject><subject>Humans</subject><subject>Mammary gland diseases</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Patient Participation - psychology</subject><subject>Pharmacology. Drug treatments</subject><subject>Prospective Studies</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Tumors</subject><issn>1551-7144</issn><issn>1559-2030</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><recordid>eNpF0E1LxDAQBuAgiruu_gAvkoveWjNN06RH8WuFBS_uuaTpZM3aL5Ms6r-36IqnGZiHF94h5BxYCgyK621qTEwzxmTKeMoYHJA5CFEmGePs8GeHREKez8hJCFvGeCEKcUxmIHOeK8jmZH2HxgU39Emn31y_obpvaO1Rh0iN7g16alrXO6NbGr3TbaDL4YPi54je4XSn5lW3LfYbDFTH6OKuwXBKjuxE8Ww_F2T9cP9yu0xWz49PtzerZMx4GRMB1hoOmSnAMMmBlVbWtimURZAqExKtkAWWpTTM5KKWmeWMo4VcGQt1wxfk6jd39MP7DkOsOhcMtq3ucdiFqlA8L5WACV7s4a7usKlG7zrtv6q_R0zgcg90mLpaP3V34d-VIJQCxr8B0E5uCw</recordid><startdate>20071101</startdate><enddate>20071101</enddate><creator>MANCINI, Julien</creator><creator>GENEVE, Jean</creator><creator>JIMENEZ, Marta</creator><creator>TARPIN, Carole</creator><creator>REYNIER, Claire Julian</creator><creator>DALENC, Florence</creator><creator>GENRE, Dominique</creator><creator>MONNIER, Alain</creator><creator>KERBRAT, Pierre</creator><creator>LARGILLIER, Rémy</creator><creator>SERIN, Daniel</creator><creator>RIOS, Maria</creator><creator>ROCHE, Henri</creator><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>20071101</creationdate><title>Decision-making and breast cancer clinical trials How experience challenges attitudes</title><author>MANCINI, Julien ; GENEVE, Jean ; JIMENEZ, Marta ; TARPIN, Carole ; REYNIER, Claire Julian ; DALENC, Florence ; GENRE, Dominique ; MONNIER, Alain ; KERBRAT, Pierre ; LARGILLIER, Rémy ; SERIN, Daniel ; RIOS, Maria ; ROCHE, Henri</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p239t-51ffc312c61c073109f7bfd68fe178257ef576e997c0c45b72f303ef148cf1bd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Adult</topic><topic>Attitude</topic><topic>Biological and medical sciences</topic><topic>Breast Neoplasms</topic><topic>Clinical trial. Drug monitoring</topic><topic>Clinical Trials as Topic</topic><topic>Decision Making</topic><topic>Female</topic><topic>France</topic><topic>General pharmacology</topic><topic>Gynecology. Andrology. Obstetrics</topic><topic>Health Care Surveys</topic><topic>Humans</topic><topic>Mammary gland diseases</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Patient Participation - psychology</topic><topic>Pharmacology. Drug treatments</topic><topic>Prospective Studies</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>MANCINI, Julien</creatorcontrib><creatorcontrib>GENEVE, Jean</creatorcontrib><creatorcontrib>JIMENEZ, Marta</creatorcontrib><creatorcontrib>TARPIN, Carole</creatorcontrib><creatorcontrib>REYNIER, Claire Julian</creatorcontrib><creatorcontrib>DALENC, Florence</creatorcontrib><creatorcontrib>GENRE, Dominique</creatorcontrib><creatorcontrib>MONNIER, Alain</creatorcontrib><creatorcontrib>KERBRAT, Pierre</creatorcontrib><creatorcontrib>LARGILLIER, Rémy</creatorcontrib><creatorcontrib>SERIN, Daniel</creatorcontrib><creatorcontrib>RIOS, Maria</creatorcontrib><creatorcontrib>ROCHE, Henri</creatorcontrib><creatorcontrib>Patients' Committee for Clinical Trials of the Ligue Nationale</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>Contemporary clinical trials</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>MANCINI, Julien</au><au>GENEVE, Jean</au><au>JIMENEZ, Marta</au><au>TARPIN, Carole</au><au>REYNIER, Claire Julian</au><au>DALENC, Florence</au><au>GENRE, Dominique</au><au>MONNIER, Alain</au><au>KERBRAT, Pierre</au><au>LARGILLIER, Rémy</au><au>SERIN, Daniel</au><au>RIOS, Maria</au><au>ROCHE, Henri</au><aucorp>Patients' Committee for Clinical Trials of the Ligue Nationale</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Decision-making and breast cancer clinical trials How experience challenges attitudes</atitle><jtitle>Contemporary clinical trials</jtitle><addtitle>Contemp Clin Trials</addtitle><date>2007-11-01</date><risdate>2007</risdate><volume>28</volume><issue>6</issue><spage>684</spage><epage>694</epage><pages>684-694</pages><issn>1551-7144</issn><eissn>1559-2030</eissn><abstract>The aim of this study was to measure women's preferences about decision-making and their impact to participate or not to a hypothetical randomised controlled trial (RCT).
We surveyed prospectively breast cancer patients invited to participate in a clinical RCT (group 1a=201 acceptances, group 1b=66 refusals) or not invited (group 2=188). All women had the same treatment.
Decision-making preferences of patients who had refused clinical RCT entry were more patient's centred (72.3%) compared to those of patients who accepted (35.0%, P<0.001). Altruism was not a significant determinant of patients' participation. Randomisation was considered acceptable in 52.0% (group 1a) compared to 16.9% and 21.1% for group 1b or group 2, respectively (P<0.001). It was the main predictor of willingness to participate in a hypothetical RCT (adjusted odds ratio (OR(adj)) 4.6; 95% confidence interval [2.7-7.7]; P<0.001) with the patient group allocation (OR(adj) group 1a=5.0 [2.9-8.7]; group 1b=0.2 [0.0-0.8]; group 2=1 [referent]; P<0.001). After multivariate adjustment, willingness to participate was also significantly related with medical decision-making preferences (OR(adj) 2.2 [1.0-4.9]; P=0.045), with the feeling of being unable to refuse a doctor's proposal (OR(adj) 1.8 [1.1-3.2]; P=0.031), and with satisfaction with doctors' communication (OR(adj) 3.1 [1.5-7.8]; P<0.001).
Patients' acceptance to participate in a RCT is preferred to be doctor's decision, whereas refusal is a personal one. When proposing a RCT, doctors must deal with patients' a priori negative feelings about randomisation. They should thoroughly discuss the reasons for and importance of randomisation as well as the other aspects of participating in the trial in order to give patients all of the information they need to make an informed decision.</abstract><cop>New York, NY</cop><pub>Elsevier</pub><pmid>17434812</pmid><doi>10.1016/j.cct.2007.03.001</doi><tpages>11</tpages></addata></record> |
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| ispartof | Contemporary clinical trials, 2007-11, Vol.28 (6), p.684-694 |
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| source | ScienceDirect Freedom Collection 2022-2024 |
| subjects | Adult Attitude Biological and medical sciences Breast Neoplasms Clinical trial. Drug monitoring Clinical Trials as Topic Decision Making Female France General pharmacology Gynecology. Andrology. Obstetrics Health Care Surveys Humans Mammary gland diseases Medical sciences Middle Aged Patient Participation - psychology Pharmacology. Drug treatments Prospective Studies Randomized Controlled Trials as Topic Tumors |
| title | Decision-making and breast cancer clinical trials How experience challenges attitudes |
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