Weight Management in Obese Cancer Patients During Curative Active Treatment (CANOBESE Study): A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Accrual
研究概览
简要总结
This is a feasibility study intervention to fifty cancer patients with obesity and with newly diagnosed stage II-IV solid tumors undergoing curative treatment recruited at the Catalan Institute of Oncology (ICO) in L'Hospitalet, Spain.
The investigators hypothesize that weight management during cancer treatment could enhance health outcomes for this population. The feasibility of a multimodal weight loss management program will be assesses, including a personalized hypocaloric and high-protein diet combined with a supervised exercise home-program and behavioural support.
详细描述
The single-arm intervention will consist of a multimodal weight management program, including a personalized hypocaloric and high-protein diet combined with a supervised exercise home-program and behavioural support. Hypocaloric diet will be individualized according to their energy requirements estimated and then applying a 20% caloric restriction. In order to reduce body weight and maintain muscle mass, a high-protein diet will be provided consisting of 1.5 g of protein/kg/day.
Participants will be provided with a 3-day food record (3-DFR) chart prior to their baseline visit. After a full nutritional evaluation, the dietitian will create a diet plan unique to the participant. For those participants struggling to attain their recommended intake or anticipating protein intake to be challenging, an oral whey powder supplement will be provided for the duration of the study. Additional approaches to overcoming dietary challenges will include information/resources on nutritional symptom management that can impact dietary intake and/or high-protein recipes.
The exercise program will be based on supervised aerobic and resistance exercise home-based training sessions 3 times/week. The sessions will be 60 minutes long and will include 5 minutes of flexibility, followed by 25 minutes of aerobic exercises, 25 minutes of resistance exercises, and 5 minutes of balance exercises. The physiotherapist will supervise the sessions and will provide monthly individual face-to-face counselling to assure adherence to the protocol. The investigators have designed an individualized exercise program that fits the current patient's clinical situation. Each patient will receive a fitness tracker band to monitor his/her activity.
Behavioural support will include problem-solving strategies and practical tools to facilitate participants' self-control on emotional eating or stress-driven behaviours. Targeted behaviour goals will be set. A psychologist will provide technical support and training to the dietitian and the physiotherapist to improve their skills to provide behavioural changes and motivation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (age 18+) with pathologically confirmed malignant solid tumors, stage II-IV, elected for oncological treatment (chemo, radio, or both) with curative intend.
- •Expected oncological treatment time ≥ 3 months.
- •BMI ≥ 30 kg/m²
- •Resident in the Barcelona area up to the completion of cancer treatment.
- •ECOG Perfomance Status (PS) 0-1
- •Availability of internet access.
排除标准
- •Patients with melanoma and brain tumours.
- •Surgery as the only treatment.
- •Tumour localizations with high risk of malnutrition (such as head and neck, upper gastrointestinal tract, or pancreatic cancer):
- •Pregnancy or breastfeeding
- •Another active malignancy
- •Current health or medical condition that affects weight status, e.g., untreated hyper- or hypothyroidism,etc
- •Pre-existing medical condition that precludes adherence to unsupervised exercise, e.g., severe orthopedic conditions, scheduled for a hip or knee replacement, bone metastases, paralysis, dementia, untreated stage 3 hypertension, or unstable angina, heart attack, congestive heart failure or conditions that dictated hospitalization or oxygen within 6-months.
- •Unable to read or understand Spanish or Catalan
- •Enrolled in a weight loss program
- •Active suicidal ideation, anorexia, bulimia, binge eating disorder, current substance abuse or dependence (besides nicotine dependence)
- •Use of pacemaker or another electrical implanted device
- •History of bariatric (or LapBand) surgery, or considering or currently on a wait-list for bariatric or LapBand surgery
- •Patients with any concurrent medical or psychological condition that, in the investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol.
结局指标
主要结局
Accrual
时间窗: From baseline to end of cancer treatment (3 to 9 months)
Feasibility will be evaluated based on participant accrual, measured by the weekly enrollment rate and the total duration required to achieve the target sample size.
Retention
时间窗: From baseline to end of cancer treatment (3 to 9 months)
Feasibility will be assessed based on participant retention, monitored through attendance records signed at each visit. Investigators will calculate the retention rate, dropout rate, time to dropout, and reasons for discontinuation.
Fidelity of the programme delivery
时间窗: From baseline to end of cancer treatment (3 to 9 months)
Feasibility based on fidelity of the intervention will be assessed using a patient-completed checklist after each dietetic and physiotherapy session. Items will be scored as: +1: session content delivered as intended, 0: content omitted, -1: content delivered in a way that deviates from protocol. Fidelity scores will be aggregated, and if overall fidelity drops below 80%, retraining may be considered. Additionally, patients will complete a final evaluation form at the end of the program assessing intervention load, frequency, delivery format, behavioral support, and perceived value (e.g., effort, satisfaction, willingness to repeat).
Nutritional adherence
时间窗: From baseline to end of cancer treatment (3 to 9 months)
Feasibility based on adherence will be evaluated using a 24-hour dietary recall to assess energy and protein intake. At the end of the intervention period, dietary adherence will also be defined as a 10-20% reduction in baseline calorie intake, along with maintenance or an increase in protein intake.
Physical activity adherence
时间窗: From baseline to end of cancer treatment (3 to 9 months)
Feasibility based on physical activity adherence will be assessed through physiotherapist evaluations and wearable device tracking.
Ocurrance of any serious or life-threatening adverse events (Safety)
时间窗: Throughout the study period (from baseline to end of intervention, 3 to 9 months)
Safety will be evaluated by monitoring the occurrence of any serious or life-threatening adverse events that may be attributable to the intervention. Specifically, investigators will record physical or cardiac events resulting in overnight hospitalization. The clinical team will assess and document whether each event is related to the dietary, exercise, or behavioral components of the intervention.
次要结局
- Change in Body Weight and Body Composition(Baseline to end of treatment (approx. 3 to 9 months))
- Change in Eating Self-Efficacy(Baseline to the end of intervention (approx. 3 to 9 months))
- Change in physical activity self-efficacy(Baseline to the end of intervention (approx. 3 to 9 months))
- Change in Autonomous Motivation(Baseline to the end of intervention (approx. 3 to 9 months))
- Modified Glasgow Prognostic Score(Baseline and end of treatment (3 to 9 months))
研究者
Lorena Arribas
Principal Investigator
Institut d'Investigació Biomèdica de Bellvitge