Effectiveness of a Multimodal Education and Support Program for the Prevention of Cancer Related Cachexia for Patients and Their Family Caregiver
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline in pre-cachexia stage against cachexia criteria at 12 weeks
研究概览
简要总结
The aim of the study is to evaluate the effectiveness of a multifactorial education and support program for the prevention of cancer-related cachexia syndrome, for patients and their family caregivers during anti-cancer treatment.
详细描述
After being informed about the study and the need to nominate a family caregiver, all patients and their family caregiver giving written informed consent, they will undergo a 12-weeks multimodal program. Randomly they will divided into two groups (intervention and control). This 12-weeks multimodal program includes 4 meetings (with cancer nurse and clinical dietician). In this 4 meetings (about 30 minutes) they will have blood tests (CRP, Albumin levels), body composition measurements, questionnaires, education on their diet and symptom management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •18 years old or older
- •Participants must be diagnosed with solid tumour (stomach, colorectal, pancreas, breast, lung)
- •Participants needing chemotherapy/immunotherapy/hormone therapy/target therapy
- •Participants must be normal or pre cachectic as defined by the guidelines
- •Read and understand Greek or English
排除标准
- •Haematologic tumors
- •Parenteral Nutrition
- •ECOG Performance status >2 or Karnofsky Performance Status <60%
- •Participant who can not introduce a family caregiver
- •Participants in cachexia or refractory cachexia stage as defined by the guidelines below:
- •>5% weight loss over the past 6 months (in absence of simple starvation); OR
- •BMI <20 and any degree of weight loss >2%; OR
- •Appendicular skeletal muscle index consistent with sarcopenia (whole body fat-free mass index without bone determined by bioelectrical impedance (men <14.6 kg/m²; women <11.4 kg/m²) and weight loss >2%
- •Patients who use complementary therapies (ex-acupuncture)
结局指标
主要结局
Change from baseline in pre-cachexia stage against cachexia criteria at 12 weeks
时间窗: Baseline and week 4, week 8, week 12
To assess the patient's baseline cancer cachexia stage with weight (weight loss \<5% in previous three months, kg), height (cm) and BMI (BMI \> 20) measurements.
次要结局
- Change from baseline in inflammation based on the CRP test at 12 weeks(Baseline and week 4, week 8, week 12)
- Change from baseline in edema according to albumin levels from baseline at 12 weeks(Baseline and week 4, week 8, week 12)
- Change from baseline of patient's Quality of life on the FAACT questionnaire (score) at 12 weeks(Baseline and week 12)
- Change from baseline (week 4) of family caregiver's Quality of life on the CarGOQoL questionnaire (score) at 12 weeks(Week 4 and week 12)
研究者
Dr. Andreas Charalambous
Associate Professor Oncology and Palliative Care
Cyprus University of Technology