BMC Cancer Study protocol Beating the blues after Cancer: randomised controlled trial of a tele-based psychological intervention for high distress patients and carers Suzanne K Chambers*1,2, Afaf Girgis3, Stefano Occhipinti1, Sandy Hutchison1, Jane Turner4, Rob Carter5 and Jeff Dunn1,2 BioMed Central Open Access Address: 1Griffith Institute for Health and Medical Research, Griffith University, Brisbane, Australia, 2Viertel Centre for Research in Cancer Control, Cancer Council Queensland, Brisbane, Australia, 3Centre for Health Research & Psycho-oncology, Cancer Council NSW & University of Newcastle, Newcastle, Australia, 4School of Medicine, University of Queensland, Brisbane, Australia and 5Deakin Health Economics, Deakin University, Melbourne, Australia Email: Suzanne K Chambers* - suzannechambers@cancerqld.org.au; Afaf Girgis - Afaf.Girgis@newcastle.edu.au; Stefano Occhipinti - s.occhipinti@griffith.edu.au; Sandy Hutchison - sandyhutchison@cancerqld.org.au; Jane Turner - jane.turner@uq.edu.au; Rob Carter - rob.carter@deakin.edu.au; Jeff Dunn - jeffdunn@cancerqld.org.au * Corresponding author Published: 17 June 2009 BMC Cancer 2009, 9:189 doi:10.1186/1471-2407-9-189 This article is available from: http://www.biomedcentral.com/1471-2407/9/189 Received: 22 May 2009 Accepted: 17 June 2009 © 2009 Chambers et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Abstract Background: The diagnosis and treatment of cancer is a major life stress such that approximately 35% of patients experience persistent clinically significant distress and carers often experience even higher distress than patients. This paper presents the design of a two arm randomised controlled trial with patients and carers who have elevated psychological distress comparing minimal contact self management vs. an individualised tele-based cognitive behavioural intervention. Methods/design: 140 patients and 140 carers per condition (560 participants in total) will been recruited after being identified as high distress through caller screening at two community-based cancer helplines and randomised to 1) a single 30-minute telephone support and education session with a nurse counsellor with self management materials 2) a tele-based psychologist delivered five session individualised cognitive behavioural intervention. Session components will include stress reduction, problem-solving, cognitive challenging and enhancing relationship support and will be delivered weekly. Participants will be assessed at baseline and 3, 6 and 12 months after recruitment. Outcome measures include: anxiety and depression, cancer specific distress, unmet psychological supportive care needs, positive adjustment, overall Quality of life. Discussion: The study will provide recommendations about the efficacy and potential economic value of minimal contact self management vs. tele-based psychologist delivered cognitive behavioural intervention to facilitate better psychosocial adjustment and mental health for people with cancer and their carers. Trial Registration: ACTRN12609000301268. Page 1 of 7 (page number not for citation purposes)