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NCT Number: NCT07356726

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

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.

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Key information

Conditions

Cancer Survivorship Cancer Neoplasms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edge Hill University - Department of Psychology

Ormskirk, Lancashire, L39 4QP, United Kingdom

Location contact

Kian Hughes, PhD Candidate

CONTACT

[email protected]

+44 01695 584508

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: FMW-UK

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.

Other names: Information Pack Control

Primary outcomes

  1. Recruitment Rate

    Time frame: 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.

  2. Intervention Adherence: Modules Accessed

    Time frame: 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.

  3. Intervention Adherence: Modules Completed

    Time frame: At post-intervention (week 4)

    The number of intervention modules completed by each participant on the Finding My Way-UK platform.

  4. Retention Rate at Post-Intervention

    Time frame: At post-intervention (week 4)

    Assessed by the percentage of participants who complete the post-intervention outcome assessment.

  5. Retention Rate at 3-Month Follow-Up

    Time frame: At 3 months post-intervention

    The percentage of participants who complete the 3-month post-intervention outcome assessment.

  6. Qualitative Acceptability of the Intervention

    Time frame: 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.

  7. Quantitative Acceptability of the Intervention

    Time frame: 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 outcomes

  1. Change from Baseline in Benefit Finding Score

    Time frame: 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.

  2. Change from Baseline in Satisfaction with Life

    Time frame: 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.

  3. Change from Baseline in Hope

    Time frame: 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.

  4. Change from Baseline in Resilience

    Time frame: 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.

Other outcomes

  1. Change from Baseline in Self-Management Self-Efficacy

    Time frame: Baseline (pre-intervention), post-intervention (week 4), and 3 months post-intervention

    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).

  2. Information-Seeking Style

    Time frame: At baseline (pre-intervention)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kian Hughes, PhD Candidate

CONTACT

[email protected]

+44 01695 584508

Nicholas J Hulbert-Williams, PhD

CONTACT

+44 01695 584508

Sponsors and collaborators

Lead sponsor

Edge Hill University

Other

Collaborators

  • Flinders University

Registry information

Official study title

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

Acronym: FMW-UK

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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