Finding My Way-UK: Promoting Positive Psychological Outcomes in People Living With and Beyond Curatively Treated Cancer (FMW-UK)

Finding My Way-UK: Promoting Positive Psychological Outcomes in People Living With and Beyond Curatively Treated Cancer: A Pilot Randomised Trial

The goal of this pilot randomised trial is to evaluate whether an online psychosocial intervention (Finding My Way-UK) is feasible and acceptable for individuals living with and beyond curatively treated cancer. The main questions it aims to answer are:

1. Is Finding My Way-UK feasible and acceptable for individuals living with and beyond curatively treated cancer?
2. Are there preliminary signals of efficacy in benefit finding and other well-being outcomes (hope, resilience, and subjective well-being)?
3. What is the potential role of information-seeking styles and self-management self-efficacy?

Participants will be randomly assigned to one of two groups:

1. Finding My Way-UK Intervention group: access a four-week, self-guided online program with six modules covering coping with treatment side effects, managing emotions, social support, body image, and post-treatment adjustment.
2. Control group: receive a digital information pack listing national psychological support resources.

All study activities will take place online. Participants will complete questionnaires before the program, after four weeks, and three months later.

Study Overview

• Status: Not yet recruiting
• Conditions: Neoplasms; Cancer; Cancer Survivorship
• Intervention / Treatment: Behavioral: Finding My Way-UK; Other: Treatment-As-Usual Control

Detailed Description

Finding My Way-UK is a broad psychosocial intervention that integrates theoretical foundations from cognitive-behavioural therapy, psychoeducation, and exercises from third-wave approaches such as mindfulness meditation. Originally developed in Australia, the program demonstrated efficacy in reducing distress among women with breast cancer. It has since been culturally adapted for the UK cancer-care context and previously underwent a pilot trial assessing its applicability to UK participants and preliminary signals of efficacy on distress outcomes.

Based on feedback from that earlier trial, several design modifications have been introduced to enhance feasibility and engagement: (i) The intervention duration has been reduced from six weeks to four weeks; and (ii) Participants will have immediate access to all six modules upon logging in, rather than the previous sequential weekly release. Additionally, recruitment will be conducted entirely online through collaborations with cancer charities and social-media outreach.

To the best of our knowledge, this represents the first online, self-guided, broad psychosocial intervention that aims to assess positive psychological outcomes in individuals living with and beyond curatively treated cancer. This pilot trial is therefore intended to evaluate the feasibility and acceptability of the revised design and to provide preliminary data to inform a future, fully powered randomised controlled trial.

Benefit finding, hope, resilience, and subjective well-being will be assessed to explore preliminary signals of efficacy. Given the pilot nature of the study and the modest sample size, analyses of these outcomes will be descriptive and exploratory only, focusing on effect-size estimation and clinically meaningful change rather than formal hypothesis testing.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kian Hughes, PhD Candidate; Phone Number: +44 01695 584508; Email: hugheski@edgehill.ac.uk
• Study Contact Backup: Name: Nicholas J Hulbert-Williams, PhD; Phone Number: +44 01695 584508

Study Locations

• United Kingdom
  • Lancashire
    • Ormskirk, Lancashire, United Kingdom, L39 4QP
      • Edge Hill University - Department of Psychology
      • Contact: Kian Hughes, PhD Candidate; Phone Number: +44 01695 584508; Email: hugheski@edgehill.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with any cancer within the past 12 months;
• Cancer is being (or, indeed, was) treated with curative intent;
• Aged 16 years or older;
• Possess sufficient English proficiency to provide informed consent and use the program;
• Able to access the internet and have access to an email address (or are willing to set an email address up with our help).

Exclusion Criteria:

• Diagnosis of cancer not being treated with curative intent (for example, metastatic, stage IV, or otherwise advanced-stage disease);
• And/Or have a severe comorbidity that may hinder their ability to participate fully (such as being unable to complete study procedures or provide informed consent).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Finding My Way-UK Intervention; Participants receive immediate access to the Finding My Way-UK online psychosocial program for four weeks. The program includes six self-guided modules on topics such as: treatment and communication with treatment teams, coping with treatment side effects, managing emotions, identity and body image, social support, and post-treatment adjustment.	Behavioral: Finding My Way-UK; Self-guided, web-based psychosocial intervention integrating cognitive-behavioural, psychoeducational, and mindfulness-based strategies to support people living with and beyond curatively treated cancer. Six modules delivered online; participants complete flexibly over four weeks.; Other Names: FMW-UK
Other: Control - Information Pack; Participants receive a digital information pack listing national psychological support resources for people living with and beyond cancer (e.g., Macmillan Cancer Support, Maggie's). This arm represents a treatment-as-usual control providing publicly available information but no structured psychosocial content.	Other: Treatment-As-Usual Control; Digital information pack (PDF) signposting to existing UK cancer-support organisations and psychological resources. Distributed by email; no structured therapeutic program or study-specific content.; Other Names: Information Pack Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Rate	The feasibility of recruitment will be assessed by the number of participants enrolled in the study per month.	From enrolment of the first participant until the recruitment target is reached (up to 6 months)
Intervention Adherence: Modules Accessed	The level of engagement with the Finding My Way-UK program, defined as the number of intervention modules accessed (opened) by each participant on the Finding My Way-UK platform.	At post-intervention (week 4)
Intervention Adherence: Modules Completed	The number of intervention modules completed by each participant on the Finding My Way-UK platform.	At post-intervention (week 4)
Retention Rate at Post-Intervention	Assessed by the percentage of participants who complete the post-intervention outcome assessment.	At post-intervention (week 4)
Retention Rate at 3-Month Follow-Up	The percentage of participants who complete the 3-month post-intervention outcome assessment.	At 3 months post-intervention
Qualitative Acceptability of the Intervention	At baseline, participants will be asked an open-ended question about their expectations for the intervention, specifically what they hope will change or improve. At follow-up, participants will provide free-text responses describing any unexpected changes or impacts. Free-text responses will be subjected to basic thematic analysis to identify common themes relating to participant experience and acceptability.	At post-intervention (week 4)
Quantitative Acceptability of the Intervention	At baseline, participants will be asked an open-ended question about their expectations for the intervention, specifically what they hope will change or improve. At follow-up, participants rate the extent to which the intervention met these expectations on a Likert scale ranging from 1 (not at all) to 10 (completely). Higher scores indicate greater acceptability.	At post-intervention (week 4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Benefit Finding Score	Measured using the Benefit Finding Scale (BFS). The BFS contains 17 items rated from 1 = not at all to 5 = extremely, summed to a total score range of 17-85, with higher scores indicating greater benefit finding. Analyses will be descriptive and exploratory, focusing on estimating pre-post effect sizes and the proportion of participants showing reliable improvement using Reliable Change Indices; no formal hypothesis testing will be performed.	Baseline (pre-intervention), post-intervention (week 4), and 3 months post-intervention
Change from Baseline in Satisfaction with Life	Subjective well-being will be assessed with the Satisfaction with Life Scale (SWLS). The SWLS comprises 5 items rated from 1 = strongly disagree to 7 = strongly agree, summed to give a total score range of 5-35, where higher scores reflect greater life satisfaction.	Baseline (pre-intervention), post-intervention (week 4), and 3 months post-intervention
Change from Baseline in Hope	Measured using the Herth Hope Index (HHI). The HHI includes 12 items rated 1 = strongly disagree to 4 = strongly agree, summed for a total score range of 12-48; higher values indicate greater hope.	Baseline (pre-intervention), post-intervention (week 4), and 3 months post-intervention
Change from Baseline in Resilience	Measured using the Connor-Davidson Resilience Scale-10 (CD-RISC-10). Ten items rated 0 (not true at all) to 4 (true nearly all the time) yield a total score range of 0-40, with higher scores indicating greater resilience.	Baseline (pre-intervention), post-intervention (week 4), and 3 months post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Self-Management Self-Efficacy	Measured using the Self-Efficacy for Managing Chronic Disease Scale. Six items rated 1-10; mean score represents overall self-efficacy (higher scores indicate higher self-management self-efficacy).	Baseline (pre-intervention), post-intervention (week 4), and 3 months post-intervention
Information-Seeking Style	Assessed using the Cancer Information-Seeking Preferences Questionnaire, a single-item measure that classifies participants into one of five information-seeking styles: intense seekers, complementary seekers, fortuitous seekers, minimal/uninterested seekers, or guarded avoiders.	At baseline (pre-intervention)

Collaborators and Investigators

• Sponsor: Edge Hill University
• Collaborators: Flinders University
• Investigators: Principal Investigator: Kian Hughes, PhD Candidate, Edge Hill University

Publications and helpful links

General Publications

• Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
• Campbell-Sills L, Stein MB. Psychometric analysis and refinement of the Connor-davidson Resilience Scale (CD-RISC): Validation of a 10-item measure of resilience. J Trauma Stress. 2007 Dec;20(6):1019-28. doi: 10.1002/jts.20271.
• Loiselle CG. Cancer information-seeking preferences linked to distinct patient experiences and differential satisfaction with cancer care. Patient Educ Couns. 2019 Jun;102(6):1187-1193. doi: 10.1016/j.pec.2019.01.009. Epub 2019 Jan 18.
• Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001 Nov-Dec;4(6):256-62.
• Herth K. Abbreviated instrument to measure hope: development and psychometric evaluation. J Adv Nurs. 1992 Oct;17(10):1251-9. doi: 10.1111/j.1365-2648.1992.tb01843.x.
• Hulbert-Williams NJ, Leslie M, Hulbert-Williams L, Koczwara B, Watson EK, Hall PS, Ashley L, Coulson NS, Jackson R, Millington S; 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 Sep 20;10(9):e31976. doi: 10.2196/31976.
• Beatty L, Kemp E, Coll JR, Turner J, Butow P, Milne D, Yates P, Lambert S, Wootten A, Yip D, Koczwara B. Finding My Way: results of a multicentre RCT evaluating a web-based self-guided psychosocial intervention for newly diagnosed cancer survivors. Support Care Cancer. 2019 Jul;27(7):2533-2544. doi: 10.1007/s00520-018-4526-1. Epub 2018 Nov 9.
• Beatty L, Koczwara B, Wade T. Evaluating the efficacy of a self-guided Web-based CBT intervention for reducing cancer-distress: a randomised controlled trial. Support Care Cancer. 2016 Mar;24(3):1043-51. doi: 10.1007/s00520-015-2867-6. Epub 2015 Aug 7.
• Beatty L, Kemp E, Wade T, Koczwara B; Finding My Way study investigators. Finding My Way: protocol of a randomised controlled trial evaluating an internet self-help program for cancer-related distress. BMC Cancer. 2015 Apr 30;15:328. doi: 10.1186/s12885-015-1322-x.
• Antoni MH, Lehman JM, Kilbourn KM, Boyers AE, Culver JL, Alferi SM, Yount SE, McGregor BA, Arena PL, Harris SD, Price AA, Carver CS. Cognitive-behavioral stress management intervention decreases the prevalence of depression and enhances benefit finding among women under treatment for early-stage breast cancer. Health Psychol. 2001 Jan;20(1):20-32. doi: 10.1037//0278-6133.20.1.20.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Feasibility; Acceptability; Online Intervention; Resilience; Psychosocial Intervention; Cancer Survivorship; Hope; Subjective Well-Being; Psycho-Oncology; Benefit Finding; Pilot Randomised Trial; Curatively Treated
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ETH2425-0268

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No