Christine L Paul1,2,3,4, Graham Warren5, Shalini Vinod6,7, Bettina Meiser8, Emily Stone9, Daniel Barker10, Kate White11, James McLennan12, Fiona Day10,13,14, Kristen McCarter15,10,16,13, Melissa McEnallay15,10,16,13, Jordan Tait10,16,13, Karen Canfell17,18, Marianne Weber17,19, Catherine Segan20,21. 1. University of Newcastle Priority Research Centre for Cancer Research, Innovation and Translation, Callaghan, Australia. Chris.Paul@newcastle.edu.au. 2. University of Newcastle School of Medicine and Public Health, Callaghan, NSW, Australia. Chris.Paul@newcastle.edu.au. 3. Level 4 West, Hunter Medical Research Institute, John Hunter Hospital, New Lambton Heights, Newcastle, NSW, Australia. Chris.Paul@newcastle.edu.au. 4. Hunter Cancer Research Alliance, John Hunter Hospital, New Lambton Heights, Newcastle, NSW, Australia. Chris.Paul@newcastle.edu.au. 5. Department of Radiation Oncology, Department of Cell and Molecular Pharmacology, Medical University of South Carolina, Charleston, SC, USA. 6. Cancer Therapy Centre, Liverpool Hospital, Liverpool, NSW, Australia. 7. South Western Sydney Clinical School and Ingham Institute for Applied Medical Research, Liverpool, NSW, Australia. 8. Prince of Wales Clinical School, University of New South Wales, Kensington, NSW, 2052, Australia. 9. St Vincent's Hospital Sydney, Kinghorn Cancer Centre, University of NSW, Kensington, Australia. 10. University of Newcastle School of Medicine and Public Health, Callaghan, NSW, Australia. 11. Faculty of Medicine and Health, University of Sydney, CNRU Sydney Local Health District, Sydney, Australia. 12. St Vincent's Hospital Sydney, Darlinghurst, NSW, Australia. 13. Hunter Cancer Research Alliance, John Hunter Hospital, New Lambton Heights, Newcastle, NSW, Australia. 14. Calvary Mater Newcastle, Hunter Region Mail Centre, Waratah, NSW, Australia. 15. University of Newcastle Priority Research Centre for Cancer Research, Innovation and Translation, Callaghan, Australia. 16. Level 4 West, Hunter Medical Research Institute, John Hunter Hospital, New Lambton Heights, Newcastle, NSW, Australia. 17. Cancer Research Division, Cancer Council NSW, Woolloomooloo, NSW, Australia. 18. Prince of Wales Clinical School, University of New South Wales, Sydney, NSW, Australia. 19. Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia. 20. Cancer Council Victoria, Melbourne, VIC, Australia. 21. Centre for Health Policy, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, VIC, Australia.
Abstract
BACKGROUND:Cigarette smoking in people with cancer is associated with negative treatment-related outcomes including increased treatment toxicity and complications, medication side effects, decreased performance status and morbidity. Evidence-based smoking cessation care is not routinely provided to patients with cancer. The purpose of this study is to determine the effectiveness of a smoking cessation implementation intervention on abstinence from smoking in people diagnosed with cancer. METHODS: A stepped wedge cluster randomised design will be used. All sites begin in the control condition providing treatment as usual. In a randomly generated order, sites will move to the intervention condition. Based on the Theoretical Domains Framework, implementation of Care to Quit will include (i) building the capability and motivation of a critical mass of key clinical staff and identifying champions; and (ii) identifying and implementing cessation care models/pathways. Two thousand one hundred sixty patients with cancer (diagnosed in the prior six months), aged 18+, who report recent combustible tobacco use (past 90 days or in the 30 days prior to cancer diagnosis) and are accessing anti-cancer therapy, will be recruited at nine sites. Assessments will be conducted at baseline and 7-month follow-up. The primary outcome will be 6-month abstinence from smoking. Secondary outcomes include biochemical verification of abstinence from smoking, duration of quit attempts, tobacco consumption, nicotine dependence, provision and receipt of smoking cessation care, mental health and quality of life and cost effectiveness of the intervention. DISCUSSION: This study will implement best practice smoking cessation care in cancer centres and has the potential for wide dissemination. TRIAL REGISTRATION: The trial is registered with ANZCTR (www.anzctr.org.au): ACTRN ( ACTRN12621000154808 ) prior to the accrual of the first participant and will be updated regularly as per registry guidelines.
RCT Entities:
BACKGROUND: Cigarette smoking in people with cancer is associated with negative treatment-related outcomes including increased treatment toxicity and complications, medication side effects, decreased performance status and morbidity. Evidence-based smoking cessation care is not routinely provided to patients with cancer. The purpose of this study is to determine the effectiveness of a smoking cessation implementation intervention on abstinence from smoking in people diagnosed with cancer. METHODS: A stepped wedge cluster randomised design will be used. All sites begin in the control condition providing treatment as usual. In a randomly generated order, sites will move to the intervention condition. Based on the Theoretical Domains Framework, implementation of Care to Quit will include (i) building the capability and motivation of a critical mass of key clinical staff and identifying champions; and (ii) identifying and implementing cessation care models/pathways. Two thousand one hundred sixty patients with cancer (diagnosed in the prior six months), aged 18+, who report recent combustible tobacco use (past 90 days or in the 30 days prior to cancer diagnosis) and are accessing anti-cancer therapy, will be recruited at nine sites. Assessments will be conducted at baseline and 7-month follow-up. The primary outcome will be 6-month abstinence from smoking. Secondary outcomes include biochemical verification of abstinence from smoking, duration of quit attempts, tobacco consumption, nicotine dependence, provision and receipt of smoking cessation care, mental health and quality of life and cost effectiveness of the intervention. DISCUSSION: This study will implement best practice smoking cessation care in cancer centres and has the potential for wide dissemination. TRIAL REGISTRATION: The trial is registered with ANZCTR (www.anzctr.org.au): ACTRN ( ACTRN12621000154808 ) prior to the accrual of the first participant and will be updated regularly as per registry guidelines.
Authors: Sevin Baser; Vickie R Shannon; Georgie A Eapen; Carlos A Jimenez; Amir Onn; E Lin; Rodolfo C Morice Journal: Chest Date: 2006-12 Impact factor: 9.410
Authors: Louise Forsetlund; Arild Bjørndal; Arash Rashidian; Gro Jamtvedt; Mary Ann O'Brien; Fredric Wolf; Dave Davis; Jan Odgaard-Jensen; Andrew D Oxman Journal: Cochrane Database Syst Rev Date: 2009-04-15
Authors: Annika Ryan; Alison Luk Young; Jordan Tait; Kristen McCarter; Melissa McEnallay; Fiona Day; James McLennan; Catherine Segan; Gillian Blanchard; Laura Healey; Sandra Avery; Sarah White; Shalini Vinod; Linda Bradford; Christine L Paul Journal: Health Serv Outcomes Res Methodol Date: 2022-09-28