Finding My Way: Protocol of a randomised controlled trial evaluating an internet self-help program for cancer-related distress

Beatty, Lisa, Kemp, Emma, Wade, Tracey, Koczwara, Bogda, Turner, Jane, Yates, Patsy, Butow, Phyllis, Lambert, Sylvie, Wootten, Addie, Milne, Donna, Knott, Vikki, Katris, Paul, De Bono, Sue, Yip, Desmond, McKinnon, Sarah, Noelker, Simone, Zappa, Bernadette, & Allen, Judy (2015) Finding My Way: Protocol of a randomised controlled trial evaluating an internet self-help program for cancer-related distress. BMC Cancer, 15, Article Number 328.

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Abstract

Background

A cancer diagnosis elicits greater distress than any other medical diagnosis, and yet very few studies have evaluated the efficacy of structured online self-help therapeutic programs to alleviate this distress. This study aims to assess the efficacy over time of an internet Cognitive Behaviour Therapy (iCBT) intervention (‘Finding My Way’) in improving distress, coping and quality of life for individuals with a recent diagnosis of early stage cancer of any type.

Methods/Design

The study is a multi-site Randomised Controlled Trial (RCT) seeking to enrol 188 participants who will be randomised to either the Finding My Way Intervention or an attention-control condition. Both conditions are delivered online; with 6 modules released once per week, and an additional booster module released one month after program-completion. Participants complete online questionnaires on 4 occasions: at baseline (immediately prior to accessing the modules); post-treatment (immediately after program-completion); then three and six months later. Primary outcomes are general distress and cancer-specific distress, with secondary outcomes including Health-Related Quality of Life (HRQoL), coping, health service utilisation, intervention adherence, and user satisfaction. A range of baseline measures will be assessed as potential moderators of outcomes. Eligible participants are individuals recently diagnosed with any type of cancer, being treated with curative intent, aged over 18 years with sufficient English language literacy, internet access and an active email account and phone number. Participants are blinded to treatment group allocation. Randomisation is computer generated and stratified by gender.

Discussion

Compared to the few prior published studies, Finding My Way will be the first adequately powered trial to offer an iCBT intervention to curatively treated patients of heterogeneous cancer types in the immediate post-diagnosis/treatment period. If found efficacious, Finding My Way will assist with overcoming common barriers to face-to-face therapy in a cost-effective and accessible way, thus helping to reduce distress after cancer diagnosis and consequently decrease the cancer burden for individuals and the health system.

Trial registration

Australian New Zealand Clinical Trials Registry ACTRN12613000001​796 16.10.13

Impact and interest:

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ID Code: 92822
Item Type: Journal Article
Refereed: Yes
Keywords: Cancer, RCT, Coping, Distress, Internet, Intervention, Psycho-oncology, CBT
DOI: 10.1186/s12885-015-1322-x
ISSN: 1471-2407
Subjects: Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000) > NURSING (111000) > Nursing not elsewhere classified (111099)
Divisions: Current > QUT Faculties and Divisions > Faculty of Health
Current > Institutes > Institute of Health and Biomedical Innovation
Current > Schools > School of Nursing
Copyright Owner: Copyright 2015 Beatty et al.; licensee BioMed Central
Copyright Statement: This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://​creativecommons.​org/​licenses/​by/​4.​0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://​creativecommons.​org/​publicdomain/​zero/​1.​0/​) applies to the data made available in this article, unless otherwise stated.
Deposited On: 12 Feb 2016 00:39
Last Modified: 14 Feb 2016 22:36

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