A study protocol for a randomised controlled trial of an interactive web-based intervention: CancerCope

Suzanne K. Chambers, Lee Ritterband, Frances Thorndike, Lisa Nielsen, Joanne F. Aitken, Samantha Clutton, Paul Scuffham, Philippa Youl, Bronwyn Morris, Peter Baade, Jeffrey Dunn

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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).

Original languageEnglish
Article numbere017279
Pages (from-to)1-11
Number of pages11
JournalBMJ Open
Volume7
Issue number6
DOIs
Publication statusPublished - 1 Jun 2017
Externally publishedYes

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Chambers, S. K., Ritterband, L., Thorndike, F., Nielsen, L., Aitken, J. F., Clutton, S., Scuffham, P., Youl, P., Morris, B., Baade, P., & Dunn, J. (2017). A study protocol for a randomised controlled trial of an interactive web-based intervention: CancerCope. BMJ Open, 7(6), 1-11. [e017279]. https://doi.org/10.1136/bmjopen-2017-017279