NCT07356726

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. 1.Is Finding My Way-UK feasible and acceptable for individuals living with and beyond curatively treated cancer?
  2. 2.Are there preliminary signals of efficacy in benefit finding and other well-being outcomes (hope, resilience, and subjective well-being)?
  3. 3.What is the potential role of information-seeking styles and self-management self-efficacy?
  4. 4.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.
  5. 5.Control group: receive a digital information pack listing national psychological support resources.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Jan 2026Jul 2026

First Submitted

Initial submission to the registry

December 8, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

December 8, 2025

Last Update Submit

January 15, 2026

Conditions

Keywords

Cancer SurvivorshipBenefit FindingPsychosocial InterventionAcceptabilityFeasibilityPilot Randomised TrialResilienceHopeSubjective Well-BeingCuratively TreatedOnline InterventionPsycho-Oncology

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (4)

  • Change from Baseline in Benefit Finding Score

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

  • Change from Baseline in Satisfaction with Life

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

  • Change from Baseline in Hope

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

  • Change from Baseline in Resilience

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

Other Outcomes (2)

  • Change from Baseline in Self-Management Self-Efficacy

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

  • Information-Seeking Style

    At baseline (pre-intervention)

Study Arms (2)

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.

Behavioral: Finding My Way-UK

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.

Other: Treatment-As-Usual Control

Interventions

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.

Also known as: FMW-UK
Finding My Way-UK Intervention

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.

Also known as: Information Pack Control
Control - Information Pack

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edge Hill University - Department of Psychology

Ormskirk, Lancashire, L39 4QP, United Kingdom

Location

Related Publications (10)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Kian Hughes, PhD Candidate

    Edge Hill University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kian Hughes, PhD Candidate

CONTACT

Nicholas J Hulbert-Williams, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2025

First Posted

January 21, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations