Valerie A Jenkins1, Lesley J Fallowfield1. 1. Sussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton & Sussex Medical School, University of Sussex, Brighton, UK.
Abstract
BACKGROUND: Appreciation of the barriers and drivers affecting enrolment in randomised clinical trials (RCTs) is important for future trial design, communication and information provision. METHODS: As part of an intervention to facilitate UK multidisciplinary team communication about RCTs, women with breast cancer who discussed trials with doctors or research nurses completed questionnaires examining i) clarity of trial information and ii) reasons for their trial decision. RESULTS:152 women completed the questionnaires; 113/152 (74%) consented to RCT enrolment. Patients' satisfaction with communication about the trial information was very good, irrespective of participation decisions. Acceptors' and decliners' responses to 9/16 statements concerning decisions about trial participation differed significantly. 'Wanting to help with doctor's research' influenced 100% acceptors compared to 57% of decliners (p < 0.001). Decliners were more likely to be 'worried about randomisation' (20 vs. 39%; p < 0.035) and to 'want doctor to choose treatment rather than be randomised' (31 vs. 53%; p < 0.031). Primary reason for trial acceptance was altruism; 'I feel that others with my illness will benefit from the results of the trial', 58/108 (54%). CONCLUSION: A majority of women accepted RCT entry citing altruistic motivations as the primary driver for participation. Trial design and setting (metastatic or adjuvant) had little impact on participation.
RCT Entities:
BACKGROUND: Appreciation of the barriers and drivers affecting enrolment in randomised clinical trials (RCTs) is important for future trial design, communication and information provision. METHODS: As part of an intervention to facilitate UK multidisciplinary team communication about RCTs, women with breast cancer who discussed trials with doctors or research nurses completed questionnaires examining i) clarity of trial information and ii) reasons for their trial decision. RESULTS: 152 women completed the questionnaires; 113/152 (74%) consented to RCT enrolment. Patients' satisfaction with communication about the trial information was very good, irrespective of participation decisions. Acceptors' and decliners' responses to 9/16 statements concerning decisions about trial participation differed significantly. 'Wanting to help with doctor's research' influenced 100% acceptors compared to 57% of decliners (p < 0.001). Decliners were more likely to be 'worried about randomisation' (20 vs. 39%; p < 0.035) and to 'want doctor to choose treatment rather than be randomised' (31 vs. 53%; p < 0.031). Primary reason for trial acceptance was altruism; 'I feel that others with my illness will benefit from the results of the trial', 58/108 (54%). CONCLUSION: A majority of women accepted RCT entry citing altruistic motivations as the primary driver for participation. Trial design and setting (metastatic or adjuvant) had little impact on participation.
Entities:
Keywords:
Breast cancer; Patients’ reasons; Randomised clinical trials
Authors: V Jenkins; D Farewell; L Batt; T Maughan; L Branston; C Langridge; L Parlour; V Farewell; L Fallowfield Journal: Br J Cancer Date: 2010-11-30 Impact factor: 7.640
Authors: V A Jenkins; D Farewell; V Farewell; L Batt; J Wagstaff; C Langridge; L J Fallowfield Journal: Contemp Clin Trials Date: 2013-02-09 Impact factor: 2.226