A study protocol for a randomised controlled trial of an interactive web-based intervention : CancerCope
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|
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).
|Journal citation||7 (6), p. Article: e017279|
|Publisher||BMJ Publishing Group|
|Digital Object Identifier (DOI)||https://doi.org/10.1136/bmjopen-2017-017279|
|PubMed Central ID||PMC5541614|
|Open access||Published as ‘gold’ (paid) open access|
|Research or scholarly||Research|
|Funder||National Health and Medical Research Council (NHMRC)|
File Access Level
|Online||23 Jun 2017|
|Publication process dates|
|Accepted||26 Apr 2017|
|Deposited||08 Nov 2021|
|License: CC BY-NC 4.0|
|File access level: Open|
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