EMBody ('Exploring Mindsets About the Body'): Harnessing Adaptive Body Mindsets to Improve Outcomes in Childhood & AYA Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Health-Related Quality of Life
研究概览
简要总结
The aim of this study is to assess whether a digital body mindset intervention - EMBody - can instil adaptive mindsets and improve health and wellbeing in young cancer survivors aged 16-25.
详细描述
EMBody (Exploring Mindsets about the Body) is a brief digital intervention comprising documentary-style films and reflection activities which aim to instil adaptive mindsets in young people who have previously completed cancer treatment. EMBody was co-created with young cancer survivors, paediatric oncologists with decades of clinical experience, and documentary filmmakers.
EMBody comprises three modules which include seven short films and accompanying reflection activities. The films feature young cancer survivors sharing their challenges of life after cancer and how their mindsets have supported them through these challenges. The films also feature oncology clinicians sharing their experience of the importance of mindsets in life after cancer, and psychological scientists who share information about what mindsets are and how they can be harnessed.
The main objective of the study is to assess whether a digital body mindset intervention (EMBody) can instil adaptive mindsets and improve health and wellbeing in young cancer survivors aged 16-25 years.
Researchers will compare the EMBody digital intervention with a waitlist attention control group to see if EMBody can instil adaptive mindsets and improve indicators of health and wellbeing in comparison to being enrolled in a study and completing study measures alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Allocation concealment is ensured through the use of Sealed Envelope, which maintains the randomisation schedule securely and prevents members of the research team responsible for enrolling participants from accessing the allocation sequence. The research team involved in data collection will not be blinded to group allocation. Members of the research team who will analyse the data will be blinded to the randomisation schedule and group allocation.
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 16-25 years
- •Previously received a cancer diagnosis including but not limited to leukemia, Hodgkins/non-Hodgkins lymphoma, osteosarcoma, Ewing sarcoma, or CNS tumour
- •Completed active, primary cancer treatment
- •Are up to seven years off treatment
排除标准
- •Significant cognitive impairment that would interfere with engagement with digital materials
- •Not able read or write in English
- •Active suicidal intent
- •Currently receiving active treatment for primary or secondary cancer
- •Completed cancer treatment more than seven years ago
研究组 & 干预措施
Mindset Intervention
Participants who are randomised to the intervention arm will complete all three modules of the EMBody intervention across six weeks. They will also complete online surveys at baseline (T0), weeks two (T1), four (T2), six (T3), 10 (T4), and 18 (T5). Data will be analysed after the T5 data collection point. There will be an additional 12-month long-term follow up (T6), with a go/no-go decision depending on trial findings; these data will be published separately.
干预措施: Mindset Intervention (Behavioral)
Waitlist Attention Control
Participants randomised to the waitlist attention control arm will complete the online surveys at the same timepoints as participants randomised to the intervention arm. After the 12-month long-term follow-up survey (T6), participants in the waitlist control arm will be sent the EMBody intervention materials.
结局指标
主要结局
Health-Related Quality of Life
时间窗: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up
The Young Adult Pediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL) measure assesses four domains of HRQOL using 23 items across separate subscales of physical, social, emotional and school functioning. For all items, individuals respond on a 5-point likert scale with an amended 7 day recall period (0= never a problem, 4= almost always a problem). Higher PedsQL 4.0 scores indicate better HRQOL.
次要结局
- Pain(Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up)
- Hospital Anxiety and Depression Scale(Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up)
- Fear of Cancer Recurrence Inventory Short Form (FCRI-SF)(Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up)
- Body Mindsets(Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up)
- Illness Mindsets(Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up)
- The Functionality Appreciation Scale(Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up)
- Post-Traumatic Growth Inventory (PTGI)(Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up)
- Bodily Threat Monitoring Scale (BTMS)(Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up)
- Physical Activity(Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up)
- The PedsQL Multidimensional Fatigue Scale in young adults(Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up)
- Global Impression of Change(Week 6 (T3))