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

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).

Inclusion Criteria:

• Hospitals in LMICs who undertake planned (elective) cancer surgery for cancer.
• Patients over 18 years of age (or the age of majority for the country);
• Patients undergoing planned (elective) surgery for cancer;
• Patients undergoing surgery where the intent is either curative or palliative;
• Patients must be able and willing to provide written informed consent (signature or a fingerprint).

Exclusion Criteria:

• Children (below age of majority for the country);
• Patients undergoing emergency surgery;
• Any operative indication other than cancer;
• Patients unable to provide written informed consent;