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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Randomized Controlled Trials
Psychology
Neoplasms
Research Ethics Committees
Internet
Cost-Benefit Analysis
Thermometers
Social Adjustment
Queensland
Patient Education
Informed Consent
Craniocerebral Trauma
Ethics
Psychiatry
Dementia
Registries
Quality of Life

Cite this

Chambers, S. K., Ritterband, L., Thorndike, F., Nielsen, L., Aitken, J. F., Clutton, S., ... 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
Chambers, Suzanne K. ; Ritterband, Lee ; Thorndike, Frances ; Nielsen, Lisa ; Aitken, Joanne F. ; Clutton, Samantha ; Scuffham, Paul ; Youl, Philippa ; Morris, Bronwyn ; Baade, Peter ; Dunn, Jeffrey. / A study protocol for a randomised controlled trial of an interactive web-based intervention : CancerCope. In: BMJ Open. 2017 ; Vol. 7, No. 6. pp. 1-11.
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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).",
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Chambers, SK, Ritterband, L, Thorndike, F, Nielsen, L, Aitken, JF, 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, vol. 7, no. 6, e017279, pp. 1-11. https://doi.org/10.1136/bmjopen-2017-017279

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; Dunn, Jeffrey.

In: BMJ Open, Vol. 7, No. 6, e017279, 01.06.2017, p. 1-11.

Research output: Contribution to journalArticleResearchpeer-review

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AU - Chambers, Suzanne K.

AU - Ritterband, Lee

AU - Thorndike, Frances

AU - Nielsen, Lisa

AU - Aitken, Joanne F.

AU - Clutton, Samantha

AU - Scuffham, Paul

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AU - Morris, Bronwyn

AU - Baade, Peter

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Chambers SK, Ritterband L, Thorndike F, Nielsen L, Aitken JF, Clutton S et al. A study protocol for a randomised controlled trial of an interactive web-based intervention: CancerCope. BMJ Open. 2017 Jun 1;7(6):1-11. e017279. https://doi.org/10.1136/bmjopen-2017-017279