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

Study Overview
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Brief Summary
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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). To identify and validate the most relevant nutritional screening tool for patients in LMICs undergoing surgery for cancer; To identify a low cost sustainable nutritional intervention for patients in LMICs undergoing surgery for cancer; 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).

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

Conditions
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Malnutrition, Surgery, Cancer

Intervention / Treatment
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* Other: Malnutrition screening


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ghana<br> | Other: Malnutrition screening<br>* Primary comparison: Prevalence of malnutrition and impact on 30-day outcomes in patients undergoing surgery for cancer<br>|
| India<br> | Other: Malnutrition screening<br>* Primary comparison: Prevalence of malnutrition and impact on 30-day outcomes in patients undergoing surgery for cancer<br>|
| Philippines<br> | Other: Malnutrition screening<br>* Primary comparison: Prevalence of malnutrition and impact on 30-day outcomes in patients undergoing surgery for cancer<br>|
| Zambia<br> | Other: Malnutrition screening<br>* Primary comparison: Prevalence of malnutrition and impact on 30-day outcomes in patients undergoing surgery for cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of malnutrition | Malnutrition as measured using validated screening tools | Immediately prior to surgery | 
| 30-day mortality rate | Death within 30 days of surgical procedure | 30 days from surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day complication rate | Defined with by Clavien-Dindo grade III or IV | 30 days from surgery | 
| Length of stay | Length of hospital admission | 30 days from surgery | 
| Re-operation rate | Re-operation within 30 days of surgical procedure | 30 days from surgery | 
| Quality of life following surgery (EQ-5D / WHODAS questionnaire) | Short-term quality of life for patients following surgery | 30 days from surgery | 
| Readmission rates | Readmission within 30 days of surgery | 30 days from surgery | 
| Recruitment rate | Time taken to recruit 200 patients | Through study duration, up to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malnutrition, Screening tools, Cancer surgery, Low and middle-income countries (LMIC)