Dataset Information

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

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).

SUBMITTER: Chambers SK

PROVIDER: S-EPMC5541614 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Publications

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

Chambers Suzanne K SK Ritterband Lee L Thorndike Frances F Nielsen Lisa L Aitken Joanne F JF Clutton Samantha S Scuffham Paul P Youl Philippa P Morris Bronwyn B Baade Peter P Dunn Jeffrey J

BMJ open 20170623 6

<h4>Introduction</h4>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.<h4>Methods and analysis</h4>In phase I, the intervention was developed on an interactive web platform and pilot tested for acce ...[more]

PMID: 28645985

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Dataset Information

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

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

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

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