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

University of Edinburgh · 2020
ClinicalTrials.gov · Datasets · License: Public Domain · 2020
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cancermalnutritionsurgery
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
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