The feasibility and acceptability of conducting a randomised controlled trial to improve Body Composition and Quality of Life of stomach cancer patients after gastrectomy in India (EASE IN)
Currently, stomach cancer is the 6th leading cancer in India, with around 60,222 cases every year. Typically, this is diagnosed in older adults (60 years and above). For these patients, stomach removal is the only curative treatment with chemotherapy.
Irrespective of their initial body composition, often measured as the proportion of fat and lean mass, the majority of these patients experience a significant loss of fat and lean mass, which could impact their survival and quality of life. To maintain a healthy body composition, patients are often provided with dietary and physical activity advice in high-income countries.
However, in low and middle-income settings, including India, body composition is rarely monitored, and lifestyle interventions are seldom provided. There is a need to understand how best to deliver appropriately diet and physical activity lifestyle intervention and more accurately evaluate outcomes.
Aims and objectives
The project aims to determine whether using information about body composition can help personalise a diet and physical activity lifestyle intervention (IBC) and is acceptable to stomach cancer survivors who recently completed treatment.
We will also assess whether using this tailored IBC intervention can improve cancer survivors’ body composition and quality of life.
How it will be done
The feasibility study will be conducted at the Tata Memorial Hospital, a leading Indian cancer care provider. We aim to recruit 70 patients whose treatment included removal of complete stomach and chemotherapy will be allocated into intervention and control groups. 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
- 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. The control group will receive routine care provided by the hospital.
Body composition, and Quality of Life measures will be collected at the time of discharge and collected every four months during follow-up visits. Diet and physical activity measures will be collected at the start and end of the study.
Although the intervention model looks promising, there is no evidence if cancer survivors in India would agree to participate in a trial after their treatment and discharge. Feasibility measures such as acceptability of randomising into the study arms and follow-up process will be assessed.
The impact of the feasibility intervention will also be assessed by measuring changes in body composition and quality of life in both the control group and the intervention group.
The project will increase our understanding of whether using measures of body composition can help personalise a diet and physical activity lifestyle intervention and is feasible and acceptable to stomach cancer survivors who recently completed treatment.
The findings of this study will help generate body composition, nutritional and physical activity guidelines for cancer survivors in India. They will also inform the design of the potential future IBC RCT and the judgment of whether to proceed to full trial.