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| Name | Class |
|---|---|
| Flinders University | OTHER |
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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:
Participants will be randomly assigned to one of two groups:
All study activities will take place online. Participants will complete questionnaires before the program, after four weeks, and three months later.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Finding My Way-UK Intervention | Experimental | 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. |
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| Control - Information Pack | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Finding My Way-UK | Behavioral | 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. |
| 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. |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kian Hughes, PhD Candidate | Contact | +44 01695 584508 | hugheski@edgehill.ac.uk | |
| Nicholas J Hulbert-Williams, PhD | Contact | +44 01695 584508 |
| Name | Affiliation | Role |
|---|---|---|
| Kian Hughes, PhD Candidate | Edge Hill University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edge Hill University - Department of Psychology | Ormskirk | Lancashire | L39 4QP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30685191 | Result | 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. | |
| 11769298 | Result | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2025 |
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Participants will be randomised 1:1 to the Finding My Way-UK intervention or a treatment-as-usual control group, with both arms running concurrently.
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| Treatment-As-Usual Control | Other | 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. |
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| 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) |
| 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 |
| 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) |
| 18157881 | Result | 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. |
| 1430629 | Result | 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. |
| 16367493 | Result | 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. |
| 34542420 | Result | 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. |
| 30411239 | Result | 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. |
| 26248651 | Result | 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. |
| 25924674 | Result | 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. |
| 11199062 | Result | 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. |
| Oct 19, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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