The feasibility and acceptability of conducting a randomised controlled trial to improve Body Composition and Quality of Life of stomach cancer patients after Total gastrectomy in India (EASE IN)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Primary outcome: Body composition will be measured using various indicators, including body mass index, adiposity measured using waist circumference and lean and fat mass measured using bioelectrical impedance analysis (Quantitative data).
研究概览
简要总结
Previous research suggests that Indian cancer survivors experience poor health and wellbeing. Little is known about stomach cancer survivors’ body composition (BC) post total gastrectomy in India despite evidence suggesting that BC could affect survival, and quality of life (QoL). The first 6-12 months post-gastrectomy are important to establish a ‘new normal for eating’ that is informed by understanding of dietary changes and eating behaviour.
The project aims to determine whether using information about body composition can help tailor a diet and physical activity lifestyle intervention (IBC) and is feasible and acceptable to stomach cancer survivors who recently completed treatment. We will also assess whether using this information can improve cancer survivors’ body composition and quality of life.
All the patients will be followed up till 8 months post primary surgeryand the intervention group will receive the tailored diet and physical activity lifestyle intervention delivered by telephone fortnightly. The level of intervention received will be based on body composition, diet and physical activity measures collected at the time of discharge. These measures, along with the quality of life, will be collected every four months during follow-up visits.
We expect to strengthen understanding of the impact of integrating body composition measures into diet and physical activity lifestyle intervention (IBC) to improve QoL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with stomach cancer who had a total gastrectomy and chemotherapy Only patients from Greater Mumbai region.
排除标准
- •Patients who had other cancers in the past two years Patients who underwent or will undergo radiotherapy (approximately 2% of the patients) Patients who had an extensive resection due to cancer spreading to other parts of the body (resection extended to spleen or oesophagus) that could result in increased post-operative complications Patients with severe frailty or dementia (based on self-reporting or medical records) Patients who might need tubal feeding following their gastrectomy Patients who have physical or mental health conditions that could limit consenting to the study or complying with the diet and physical activity recommendations.
结局指标
主要结局
Primary outcome: Body composition will be measured using various indicators, including body mass index, adiposity measured using waist circumference and lean and fat mass measured using bioelectrical impedance analysis (Quantitative data).
时间窗: 24 months
次要结局
- Secondary outcome: Quality of Life will be measured using the QLQ-C305 (Quantitative data).(ï‚· The feasibility outcomes will assess eligibility, acceptability, recruitment, and retention rates. (Quantitative data and Qualitative Data).)
研究者
Dr Manish Bhandare
Tata Memorial Hospital