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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Другое 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.

Первичные конечные точки

• Recruitment Rate [Срок оценки: From enrolment of the first participant until the recruitment target is reached (up to 6 months)]
• Intervention Adherence: Modules Accessed [Срок оценки: At post-intervention (week 4)]
• Intervention Adherence: Modules Completed [Срок оценки: At post-intervention (week 4)]
• Retention Rate at Post-Intervention [Срок оценки: At post-intervention (week 4)]
• Retention Rate at 3-Month Follow-Up [Срок оценки: At 3 months post-intervention]
• Qualitative Acceptability of the Intervention [Срок оценки: At post-intervention (week 4)]
• Quantitative Acceptability of the Intervention [Срок оценки: At post-intervention (week 4)]

Вторичные конечные точки (4)

• Change from Baseline in Benefit Finding Score [Срок оценки: Baseline (pre-intervention), post-intervention (week 4), and 3 months post-intervention]
• Change from Baseline in Satisfaction with Life [Срок оценки: Baseline (pre-intervention), post-intervention (week 4), and 3 months post-intervention]
• Change from Baseline in Hope [Срок оценки: Baseline (pre-intervention), post-intervention (week 4), and 3 months post-intervention]
• Change from Baseline in Resilience [Срок оценки: Baseline (pre-intervention), post-intervention (week 4), and 3 months post-intervention]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Великобритания · 1 центр

• Edge Hill University - Department of Psychology — Ormskirk

Публикации

• 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. PMID 30685191
• 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. PMID 11769298
• 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. PMID 18157881
• 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. PMID 1430629
• 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. PMID 16367493
• 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;1 PMID 34542420
• 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. PMID 30411239
• 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. PMID 26248651

Идентификаторы

NCT: NCT07356726 · ETH2425-0268

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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