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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ghana |
| ||
| India |
| ||
| Philippines |
| ||
| Zambia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Malnutrition screening | Other | Primary comparison: Prevalence of malnutrition and impact on 30-day outcomes in patients undergoing surgery for cancer |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing surgery for cancer in four partner LMIC countries are eligible
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| Name | Affiliation | Role |
|---|---|---|
| Ewen Harrison | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cape Coast Teaching Hospital | Cape Coast | Ghana | ||||
| Tamale Teaching Hospital |
Derived anonymised data at the patient-level may be able to be made available for sharing
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| 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-5L / WHODAS questionnaire (36 item)) | 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 |
| Tamale |
| Ghana |
| Tata medical Centre | Kolkata | India |
| CMC Ludhiana | Ludhiana | India |
| Padhar Hospital | Padhār | India |
| AIIMS | Rishikesh | India |
| Christian Medical College | Vellore | India |
| Medical Center | Manila | Philippines |
| Philippine General Hospital (UP-PGH) | Manila | Philippines |
| Rizal Medical Center | Manila | Philippines |
| The Medical City Hospital | Manila | Philippines |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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