OBesity PREVention in Children and Young People Treated with ALLtogetheR: Prehabilitation Feasibility Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Minimal Residual Disease
研究概览
简要总结
Background Leukaemia is the most common cancer in children with 800 diagnoses per year in England. To survive, children need strong treatments like chemotherapy and steroids given usually through clinical trials. The current trial used by the NHS is called ALLTogether. Fifty percent of children become obese during treatment due to increased hunger, cravings for junk foods and lack of physical activity. Obesity raises the chance of cancer relapse by 31%, makes treatment side-effects worse and makes it harder to kill off leukaemia cells, which affects how well children do during treatment, as indicated by minimal residual disease, a key predictor of prognosis.
Aims and Objectives This study (called BREVARY) aims to see if we can successfully provide personalised diet and physical activity with behaviour support for children and young people with leukaemia who are being treated with the ALLTogether trial. It will help us figure out if we can perform a bigger study, if this programme could reduce obesity and side-effects and improve survival and wellbeing.
How it will be done We plan to randomly assign participants to one of three groups; one group will get both a diet and physical activity plan, another will get only a diet plan, and the last group will receive standard care. This will take place in Hospital Infantil Universitario Nino Jesus, Madrid and Bristol Royal Hospital for Children and Southwest England NHS-sites. The diet and exercise plans will be created in partnership with the children and their families and delivered online or during regular hospital visits. The diet will follow healthy eating guidelines, consider personal food preferences (including cultural and religious needs), treatment side-effects and personal finances. Assessments of fitness and strength will be taken to plan personalised activities. During the study, the following data will also be collected: weight, height, body fat, diet, biomarkers, microbiome, muscle strength and wellbeing at three different times. "One to one" interviews will be conducted at the end to obtain feedback on their experiences with BREVARY.
This study aims to find out if children and their families/carers are willing to participate in BREVARY, if enough people sign up and stay until the end and if our interventions and health measurements are appropriate.
Potential Impact The results will help determine if a larger study can be performed, if changes are needed and what the cost will be. The study will be disseminated through networks, targeting underserved communities, healthcare professionals and affected families using accessible platforms to spread the word.
详细描述
The international randomised controlled trial registry shows that no lifestyle intervention (diet, physical activity with integrated counselling) has been performed in the UK. The IDEAL trial performed in the USA demonstrated that diet with energy intake restriction and physical activity was feasible and significantly improved Minimal Residual Disease (MRD) in children diagnosed with Acute lymphoblastic leukaemia (CYP_ALL) and treated with National Cancer Institute/Rome high-risk B-ALL protocol during induction. ALLTogether is similar and will for the first time provide an excellent platform to prevent obesity in CYP_ALL.
Obesity associated relapse is attributed to adipocyte-mediated chemo-resistance, which occurs in CYP_ALL with higher fat mass and leads to more persistent MRD. MRD is a marker of leukaemic cells and the strongest predictor of prognosis including both remission and relapse. Therefore, obesity is identified as a prognostic factor for relapse (measured by MRD) and it is associated with increased morbidity and mortality, and poorer wellbeing.
Only two dietary feasibility interventions have investigated CYP_ALL differing in the type (diet alone vs. diet and physical activity) and the length of intervention (1 - 6 months). Both showed improvements in diet quality, high participation (>70%) and 56 - 82% adherence. Indeed, the IDEAL trial also showed improvements in MRD and body composition, making it suitable to base BREVARY's design. Consensus exists regarding using patient-centre interventions in clinical settings; like the Individualised Macronutrient Meal-Equivalent Menu (Menus). This approach reduces food associated stress, anxiety and financial costs, while empowering patients and their families/carers, thus improving adherence. It has been shown to be successful in adults with breast cancer and provides a validated approach to CYP_ALL.
A systematic review showed that individualised physical activity combining fitness and strength mitigated complications in CYP_ALL. However, it was difficult to draw firm conclusions because evidence were limited by sample sizes, adherence was seldom reported and study designs were heterogenous differing in length (1 - 30 months), exercise type and intensity and assessed outcomes (e.g. cardiorespiratory fitness, strength and wellbeing). Six trials are underway including all cancers with interventions being either individualised ("as able" and play-based exercise for children aged <5 years) or employing generic exercise prescriptions with intensity "as able". They are investigating fitness, strength and wellbeing; however, none have incorporated dietary assessment or intervention.
- Research proposal
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
- None
盲法说明
It is not possible to mask the intervention - as it is diet and physical activity, diet alone or standard care
入排标准
- 年龄范围
- 5 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CYP aged between 5 - 21 years.
- •Newly diagnosed or relapsed CYP_ALL treated in University Hospital Bristol and Weston NHS Foundation Trust and Hospital Infantil Universitario Nino Jesus, Madrid
- •Within two weeks of being recruited to ALLTogether.
- •Treated with curative intent.
排除标准
- •CYP not partaking in ALLTogether.
- •CYP treated with palliative intent.
- •Those excluded by healthcare professionals or clinical reasons
研究组 & 干预措施
Diet
Individualised Dietary Intervention
干预措施: Diet (Behavioral)
Diet and Physical Activity
Individualised Dietary and Physical Activity Intervention
干预措施: Diet and physical activity (Behavioral)
Standard Care
No intervention - this is standard care
结局指标
主要结局
Minimal Residual Disease
时间窗: initial assessment, day 29, day 50 and day 78
Candidate Primary Outcome (feasibility study). Hospital own's laboratory assay
Muscle and fat mass
时间窗: Initial assessment, at 29 days, at 3 months, at 6 months
Candidate primary outcome, Multifrequency BIA FFM and FM percentage Impedance Reactant
Quality of Life
时间窗: initial assessment, at 3 months and at 6 months
Candidate Primary outcome (Quality of Life: PedQL-Cancer Module questionnaire) The PedsQL-Cancer Module includes multiple subscales that address specific areas of functioning and challenges related to cancer, such as: Pain and hurt, Nausea, Procedural anxiety, Treatment anxiety, Worry, Cognitive problems, Perceived physical appearance, Communication. To calculate scores, the items are reverse scored and linearly transformed to a Original Response Reverse Score (Transformed Score) 0 = Never 100 1. = Almost Never 75 2. = Sometimes 50 3. = Often 25 4. = Almost Always 0 Scores are reverse, thus higher scores indicate better health-related quality of life or fewer reported problems. Mean scores are calculated for each subscale by summing the item scores and dividing by the number of items answered. If more than 50% of the items in a subscale are missing, the subscale score is not computed.
Body Mass Index Z score
时间窗: initial assessment, at day 29, at 3 months and at 6 months
Candidate Primary Outcome Calculated from weight and height (weight/height\^2) WHO BMI Z score (scale score) Z-Score Range Nutritional Status \< -3 SD: Severe undernutrition (Severely underweight, stunted, or wasted) * -3 SD and \< -2 SD: Moderate undernutrition (Underweight, stunted, or wasted) * -2 SD and ≤ +1 SD: Healthy weight (Normal nutritional status) * +1 SD and ≤ +2 SD: Overweight * +2 SD: Obese
Parent's quality of life
时间窗: Initial assessment, at 3 months and at 6 months
Parents PedQL-Cancer he PedsQL Cancer Module - Parent Proxy Report is a specialized tool designed to assess health-related quality of life (HRQoL) in children and adolescents with cancer, based on the parent's perception. The Parent PedsQL Cancer Module includes the following subscales tailored to cancer-related challenges: Pain and Hurt, Nausea, Procedural Anxiety, Treatment Anxiety, Worry, Cognitive Problems, Perceived Physical Appearance, Communication To calculate scores, the items are reverse scored and linearly transformed to a 0-100 scale: 0 = 100; 1 = 75; 2 = 50; 3 = 25; 4 = 0 Higher scores indicate better health-related quality of life or fewer reported problems.
Feasibility: staff/provider adoption
时间窗: At 0, day 29, 3 months and 6 months
The proportion and characteristics of researchers and healthcare staff who choose to deliver the intervention. Outcome in percentages
Feasibility: Fidelity
时间窗: At 0, day 29, 3 months and 6 months
Fidelity scores ranging from 0 to 100 (e.g., percentage of protocol elements followed) where 0 is nothing was followed and 100 everything was followed as originally planned.
Cost-effectiveness
时间窗: At 0, 3 months and 6 months
Cost-utility analysis to evaluate the economic value of different interventions (or arms) by comparing their costs to their outcomes. This is based on quality-adjusted life in years. QALY will be generated via measurement of utility values using PedsQL-cancer and Parents PedQL-Cancer instrument mapped to the EQ-5D. Outcome: scale in pounds and euros. Total cost of control, cost of diet alone and cost of diet and physical activity
Feasibility: Participation rate
时间窗: Baseline, time 0
The proportion of the target population that actually participates in the intervention measured in frequencies
Feasibility: Representativeness
时间窗: At 0, day 29, 3 months and 6 months
The degree to which the participants reflect the broader population intended to benefit from the intervention. Outcome measure in percentages
Feasibility: Accessibility
时间窗: At 0, day 29, 3 months and 6 months
Evaluates whether the intervention is accessible to all segments of the target population, including those who are typically underrepresented. Outcome measure in percentage
Feasibility: Barriers to participation
时间窗: At 0, day 29, 3 months and 6 months
Identifies factors that prevent individuals from engaging with the intervention, such as lack of awareness, logistical issues, or cultural barriers. Outcome: qualitative
Feasibility: Effectiveness
时间窗: At 0, day 29, 3 months and 6 months
The trial will be regarded feasible if the following criteria are met: * Recruitment rate ≥ 50% * ≥ 70% of recruited families complete the trial in one of the intervention groups * ≥ 70% of families, researchers and clinical staff agree that the intervention is acceptable (survey) * Recruited participants complete ≥ 60% of the supervised sessions * ≥ 70% of families agree that the intervention is enjoyable The overall outcome is categorical: Yes, No or yes with conditions/amendments
Feasibility: Adoption
时间窗: At 0, day 29, 3 months and 6 months
Settings: the proportion of settings that agree to implement the intervention. Outcome measured in percentage.
Feasibility: Barriers and facilitators: Qualitative
时间窗: At 0, day 29, 3 months and 6 months
Identifies factors that help or hinder the willingness of organisations and individuals to adopt the intervention (e.g., cost, training requirements, organisational culture). Outcome: quaitative
次要结局
- C-Reactive Protein (CRP)(Initial assessment, at day 29, at 3 months and at 6 months)
- High Density Lipoprotein (HDL)(Initial assessment, at day 29, at 3 months and at 6 months)
- Low Density Lipoprotein (LDL)(Initial assessment, at day 29, at 3 months and at 6 months)
- Triglycerides (TGA)(Initial assessment, at day 29, at 3 months and at 6 months)
- Glucose(Initial assessment, at day 29, at 3 months and at 6 months)
- Fitness(Initial assessment, at day 29, at 3 months and at 6 months)
- Leptin(Initial assessment, at day 29, at 3 months and at 6 months)
- Food group indicators and nutrient intake(Initial assessment, at day 29, at 3 months and at 6 months)
- Physical activity levels min/day(Initial assessment, at 3 months and at 6 months)
- Handgrip strength(Initial assessment, at day 29, at 3 months and at 6 months)
- Side-effects(Throughout the study (0 - 3 months), then again at 6 months)
- Gut microbiome composition(Initial assessment and 3 months)
- Adiponectin(Initial assessment, at day 29, at 3 months and at 6 months)
- Insulin(Initial assessment, at day 29, at 3 months and at 6 months)
- Immunoglobulin A (IgA)(Initial assessment, at day 29, at 3 months and at 6 months)
- Immunoglobulin G (IgG)(Initial assessment, at day 29, at 3 months and at 6 months)
- Immunoglobulin M (IgM)(Initial assessment, at day 29, at 3 months and at 6 months)
- Total Cholesterol(Initial assessment, at day 29, at 3 months and at 6 months)
研究者
Raquel Revuelta Iniesta
Senior Lecturer in Nutrition
University of Exeter