Finding My Way-UK: Promoting Positive Psychological Outcomes in People Living With and Beyond Curatively Treated Cancer: A Pilot Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
研究概览
简要总结
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:
- Is Finding My Way-UK feasible and acceptable for individuals living with and beyond curatively treated cancer?
- Are there preliminary signals of efficacy in benefit finding and other well-being outcomes (hope, resilience, and subjective well-being)?
- What is the potential role of information-seeking styles and self-management self-efficacy?
Participants will be randomly assigned to one of two groups:
- 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.
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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).