A study protocol for a randomised controlled trial of an interactive web-based intervention : CancerCope
Journal article
Chambers, Suzanne K., Ritterband, Lee, Thorndike, Frances, Nielsen, Lisa, Aitken, Joanne F., Clutton, Samantha, Scuffham, Paul, Youl, Philippa, Morris, Bronwyn, Baade, Peter and Dunn, Jeffrey. (2017). A study protocol for a randomised controlled trial of an interactive web-based intervention : CancerCope. BMJ Open. 7(6), p. Article: e017279. https://doi.org/10.1136/bmjopen-2017-017279
Authors | Chambers, Suzanne K., Ritterband, Lee, Thorndike, Frances, Nielsen, Lisa, Aitken, Joanne F., Clutton, Samantha, Scuffham, Paul, Youl, Philippa, Morris, Bronwyn, Baade, Peter and Dunn, Jeffrey |
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Abstract | Introduction Approximately 35% of patients with cancer experience clinically significant distress, and unmet psychological supportive care needs are prevalent. This study describes the protocol for a randomised controlled trial (RCT) to assess the efficacy and cost-effectiveness of an internet-based psychological intervention for distressed patients with cancer. Methods and analysis In phase I, the intervention was developed on an interactive web platform and pilot tested for acceptability using a qualitative methodology with 21 patients with cancer. Phase II is an RCT underway with patients with or at risk of elevated psychological distress comparing: (1) static patient education website with (2) individualised web-delivered cognitive behavioural intervention (CancerCope). Participants were recruited through the Queensland Cancer Registry and Cancer Council Helpline and met the following inclusion criteria: (1) recently diagnosed with cancer; (2) able to read and speak English; (3) no previous history of head injury, dementia or psychiatric illness; (4) no other concurrent cancer; (5) phone and internet access; (5) scored ≥4 on the Distress Thermometer. Participants are assessed at four time points: baseline/recruitment and 2, 6 and 12 months after recruitment and intervention commencement. Of the 163 participants recruited, 50% met caseness for distress. The area of highest unmet supportive care needs were psychological followed by physical and daily living needs. Primary outcomes are psychological and cancer-specific distress and unmet psychological supportive care needs. Secondary outcomes are positive adjustment, quality of life and cost-effectiveness. Ethics and dissemination Ethical approval was obtained from the Griffith University Human Research Ethics Committee (Approval: PSY/70/13/HREC) and the Metro South Human Research Ethics Committee (HREC/13/QPAH/601). All participants provide informed consent prior to taking part in the study. Once completed, this study will provide recommendations about the efficacy of web-based cognitive behavioural interventions to facilitate better psychosocial adjustment for people with cancer. Trial registration number ANZCTR (ACTRN12613001026718). |
Year | 2017 |
Journal | BMJ Open |
Journal citation | 7 (6), p. Article: e017279 |
Publisher | BMJ Publishing Group |
ISSN | 2044-6055 |
Digital Object Identifier (DOI) | https://doi.org/10.1136/bmjopen-2017-017279 |
PubMed ID | 28645985 |
Scopus EID | 2-s2.0-85021276608 |
PubMed Central ID | PMC5541614 |
Open access | Published as ‘gold’ (paid) open access |
Research or scholarly | Research |
Page range | 1-10 |
Funder | National Health and Medical Research Council (NHMRC) |
Publisher's version | License File Access Level Open |
Output status | Published |
Publication dates | |
Online | 23 Jun 2017 |
Publication process dates | |
Accepted | 26 Apr 2017 |
Deposited | 08 Nov 2021 |
Grant ID | NHMRC/1056756 |
NHMRC/1054038 |
https://acuresearchbank.acu.edu.au/item/8x03y/a-study-protocol-for-a-randomised-controlled-trial-of-an-interactive-web-based-intervention-cancercope
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Publisher's version
OA_Chambers_2017_A_study_protocol_for_a_randomised.pdf | |
License: CC BY-NC 4.0 | |
File access level: Open |
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