Maintenance Notice

Due to necessary scheduled maintenance, the JMIR Publications website will be unavailable from Wednesday, July 01, 2020 at 8:00 PM to 10:00 PM EST. We apologize in advance for any inconvenience this may cause you.

Who will be affected?

Accepted for/Published in: JMIR Research Protocols

Date Submitted: Jul 12, 2021
Date Accepted: Jul 15, 2021

The final, peer-reviewed published version of this preprint can be found here:

The Finding My Way UK Clinical Trial: Adaptation Report and Protocol for a Replication Randomized Controlled Efficacy Trial of a Web-Based Psychological Program to Support Cancer Survivors

Hulbert-Williams NJ, Leslie M, Hulbert-Williams L, Koczwara B, Watson EK, Hall PS, Ashley L, Coulson NS, Jackson R, Millington S, The Finding My Way UK Trial Steering Group , Beatty L

The Finding My Way UK Clinical Trial: Adaptation Report and Protocol for a Replication Randomized Controlled Efficacy Trial of a Web-Based Psychological Program to Support Cancer Survivors

JMIR Res Protoc 2021;10(9):e31976

DOI: 10.2196/31976

PMID: 34542420

PMCID: 8491121

The Finding My Way UK Clinical Trial: Adaptation report and protocol for a replication randomised controlled efficacy trial of a web-based psychological programme to support cancer survivors

  • Nicholas J Hulbert-Williams; 
  • Monica Leslie; 
  • Lee Hulbert-Williams; 
  • Bogda Koczwara; 
  • Eila K Watson; 
  • Peter S Hall; 
  • Laura Ashley; 
  • Neil S Coulson; 
  • Richard Jackson; 
  • Sue Millington; 
  • The Finding My Way UK Trial Steering Group; 
  • Lisa Beatty

ABSTRACT

Background:

Cancer survivors frequently report a range of unmet psychological and supportive care needs; these often continue after treatment has finished, and are predictive of psychological distress and poor health-related quality of life. Online interventions demonstrate good efficacy in addressing these concerns and are more accessible than face to face interventions. Finding My Way is an online, psycho-educational and cognitive behaviour therapy intervention for cancer survivors developed in Australia. Previous trials have demonstrated Finding My Way to be acceptable, highly adhered to, and effective in reducing the impact of distress on quality of life, whilst leading to cost-savings through health-resource use reduction.

Objective:

Our study will adapt the Australian Finding My Way website for a UK cancer care context, and then undertake a single-blinded, randomised controlled trial (RCT) of Finding My Way UK against a treatment-as-usual waitlist control.

Methods:

As much as possible, our trial design replicates the existing Australian RCT of Finding My Way. Following a comprehensive adaptation of the web-resource, we will recruit 294 participants (147 per study arm) from across clinical sites in North West England and North Wales. Participants will: (i) have been diagnosed with cancer of any type in the last six months, (ii) have received anti-cancer treatment with curative intent, (iii) be over 16 years of age, (iv) be proficient in English and (v) have access to the internet and an active email address. Participants will be identified and recruited through the NIHR Clinical Research Network. Measures of distress, quality of life, and health economic outcomes will be collected using a self-report online questionnaire at baseline, mid-treatment, post-treatment and both three- and six-month follow-up. Quantitative data will be analysed using intention-to-treat Mixed-Model Repeated Measures analysis. Embedded semi-structured qualitative interviews will probe engagement with, and experiences of using, Finding My Way UK and suggestions for future improvements.

Results:

Website adaptation work was completed in January 2021. A panel of cancer survivors and healthcare professionals provided feedback on the test version of Finding My Way UK. Feedback was positive overall, though minor updates were made to website navigation, inclusivity, terminology and the wording of the Improving Communication and Sexuality and Intimacy content. Recruitment for the clinical trial commenced in April 2021. We aim to report on findings from mid 2023.

Conclusions:

Replication studies are an important aspect of the scientific process, particularly in psychological and clinical trial literatures, and especially in different geographical settings. Prior to replicating the Finding My Way trial in the UK setting, some content updating was required. If Finding My Way UK now replicates Australian findings, we will have identified a novel and cost-effective method of psychosocial care delivery for UK cancer survivors. Clinical Trial: The Finding My Way UK Trial is registered on the ISRCTN (Reference: ISRCTN14317248; Date Registered 08/04/2021).


 Citation

Please cite as:

Hulbert-Williams NJ, Leslie M, Hulbert-Williams L, Koczwara B, Watson EK, Hall PS, Ashley L, Coulson NS, Jackson R, Millington S, The Finding My Way UK Trial Steering Group , Beatty L

The Finding My Way UK Clinical Trial: Adaptation Report and Protocol for a Replication Randomized Controlled Efficacy Trial of a Web-Based Psychological Program to Support Cancer Survivors

JMIR Res Protoc 2021;10(9):e31976

DOI: 10.2196/31976

PMID: 34542420

PMCID: 8491121

Download PDF


Request queued. Please wait while the file is being generated. It may take some time.

© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.