Cancer, Cancer Survivorship, Neoplasms
Conditions
Keywords
Cancer Survivorship, Benefit Finding, Psychosocial Intervention, Acceptability, Feasibility, Pilot Randomised Trial, Resilience, Hope, Subjective Well-Being, Curatively Treated, Online Intervention, Psycho-Oncology
Brief summary
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.
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.
Interventions
BEHAVIORALFinding 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.
OTHERTreatment-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.
Sponsors
Edge Hill University
Flinders University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | From enrolment of the first participant until the recruitment target is reached (up to 6 months) | The feasibility of recruitment will be assessed by the number of participants enrolled in the study per month. |
| Intervention Adherence: Modules Accessed | At post-intervention (week 4) | 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. |
| Intervention Adherence: Modules Completed | At post-intervention (week 4) | The number of intervention modules completed by each participant on the Finding My Way-UK platform. |
| Retention Rate at Post-Intervention | At post-intervention (week 4) | Assessed by the percentage of participants who complete the post-intervention outcome assessment. |
| Retention Rate at 3-Month Follow-Up | At 3 months post-intervention | The percentage of participants who complete the 3-month post-intervention outcome assessment. |
| Qualitative Acceptability of the Intervention | At post-intervention (week 4) | 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. |
| Quantitative Acceptability of the Intervention | At post-intervention (week 4) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Benefit Finding Score | Baseline (pre-intervention), post-intervention (week 4), and 3 months post-intervention | 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. |
| Change from Baseline in Satisfaction with Life | Baseline (pre-intervention), post-intervention (week 4), and 3 months post-intervention | 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. |
| Change from Baseline in Hope | Baseline (pre-intervention), post-intervention (week 4), and 3 months post-intervention | 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. |
| Change from Baseline in Resilience | Baseline (pre-intervention), post-intervention (week 4), and 3 months post-intervention | 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. |
Countries
United Kingdom
Contacts
CONTACTKian Hughes, PhD Candidate
CONTACTNicholas J Hulbert-Williams, PhD
PRINCIPAL_INVESTIGATORKian Hughes, PhD Candidate
Edge Hill University
Outcome results
None listed