NCT04448041

CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries

A Cluster Randomised Feasibility Study of a Sustainable Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 168 (actual)
• Sponsor: University of Edinburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aims: The CRANE feasibility study (A mixed methods study of malnutrition and sustainable nutritional intervention for patients undergoing cancer surgery in low- and middle-income countries) aims to investigate the identification of pre-operative malnourishment, data collection methods and acceptability of a nutritional intervention for a future trial to improve outcomes after cancer surgery in low- and middle-income countries (LMICs). 1. To identify and validate the most relevant nutritional screening tool for patients in LMICs undergoing surgery for cancer; 2. To identify a low cost sustainable nutritional intervention for patients in LMICs undergoing surgery for cancer; 3. To establish the feasibility of delivering a randomised trial of a sustainable nutritional intervention for patients in LMICs undergoing surgery for cancer. Design: A mixed-methods study comprising of qualitative work including focus groups and interviews, trial of data collection and validation to test feasibility in clinical practice Participants: Patients undergoing elective surgery for suspected cancer in LMICs Outcomes Work package (WP) 1: The primary deliverable is the identification of a relevant, pragmatic, and acceptable nutritional screening tool. WP 2: The primary deliverable is the identification of a low-cost and sustainable nutritional intervention. Focus groups and interviews will be held with patients and clinicians to explore the sustainability, implementation and acceptability of screening and interventions. WP 3: The primary outcome will be to determine feasibility and acceptability of trial design. A number of outcome assessments and data collection instruments will be evaluated for feasibility, including anthropometric parameters and patient outcomes (30-day mortality, major post-operative complications, length of hospital stay and quality of life). A final study design, analysis plan, and health economic plan will be developed. Sample size: For this feasibility study, the investigators will conduct multidisciplinary focus groups and interviews, perform and validate malnutrition screening in 200 patients across four countries and record patient 30-day outcomes. This will also include the time taken to collect data on 200 eligible patients. This sample size has been informed from previous malnutrition data originating from a large prospective international multicentre observational cancer study (GlobalSurg 3).

Conditions

• Malnutrition
• Surgery
• Cancer

Interventions

Type	Name	Description
OTHER	Malnutrition screening	Primary comparison: Prevalence of malnutrition and impact on 30-day outcomes in patients undergoing surgery for cancer

Timeline

• Start date: 2020-09-07
• Primary completion: 2021-06-30
• Completion: 2021-11-30
• First posted: 2020-06-25
• Last updated: 2024-06-07

Locations

11 sites across 3 countries: Ghana, India, Philippines