Abstract
BackgroundA 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/DesignThe 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.DiscussionCompared 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 registrationAustralian New Zealand Clinical Trials Registry ACTRN12613000001796 16.10.13
Highlights
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
If found efficacious, Finding My Way will assist with overcoming common barriers to face-to-face therapy in a cost-effective and accessible way, helping to reduce distress after cancer diagnosis and decrease the cancer burden for individuals and the health system
Aims and hypotheses This study aims to evaluate the efficacy of the iteration of our self-help internet cancer coping intervention (‘Finding My Way’) in improving wellbeing and quality of life of early-stage cancer patients over time, using a multi-site Randomised Controlled Trial (RCT)
Summary
Internet-based self-help modalities represent one means of overcoming existing barriers to cancer patients accessing supportive care and psychosocial services, including the lack of such services within the public health system, for rural patients, and barriers to attendance even where such services are provided. This study offers the important contribution of evaluating potential moderators of change This information can be of benefit clinically when determining who to refer for online-interventions (versus who may be more suitably treated via other modalities) as well as benefitting future research via the refinement of inclusion and exclusion criteria, improving trial stratification and increasing power [30]. If found efficacious, Finding My Way will represent an important means of overcoming common barriers to faceto-face therapy in a cost-effective and accessible way, which may assist those residing in rural/remote areas Integration of such a program into the supportive care offered to cancer patients within the health system will be a promising avenue for reducing patient distress after cancer diagnosis, and for decreasing the cancer burden both on individuals and within the health system. Authors’ information Dr Lisa Beatty is a research fellow at Flinders University, South Australia, and a clinical psychologist at the Flinders Centre for Innovation in Cancer, Flinders Medical Centre, South Australia Dr Emma Kemp is a research associate at Flinders University, currently based at the Flinders Centre for Innovation in Cancer, Flinders Medical Centre, South Australia Professor Tracey Wade is the Dean, School of Psychology at Flinders University, South Australia Professor Bogda Koczwara is a medical oncologist at the Flinders Centre for Innovation in Cancer, Flinders Medical Centre, South Australia
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