Cancer, Malnutrition, Surgery
Conditions
Keywords
Malnutrition, Screening tools, Cancer surgery, Low and middle-income countries (LMIC)
Brief 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).
Interventions
OTHERMalnutrition screening
Primary comparison: Prevalence of malnutrition and impact on 30-day outcomes in patients undergoing surgery for cancer
Sponsors
University of Edinburgh
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of malnutrition | Immediately prior to surgery | Malnutrition as measured using validated screening tools |
| 30-day mortality rate | 30 days from surgery | Death within 30 days of surgical procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Re-operation rate | 30 days from surgery | Re-operation within 30 days of surgical procedure |
| Quality of life following surgery (EQ-5D-5L / WHODAS questionnaire (36 item)) | 30 days from surgery | Short-term quality of life for patients following surgery |
| 30-day complication rate | 30 days from surgery | Defined with by Clavien-Dindo grade III or IV |
| Recruitment rate | Through study duration, up to one year | Time taken to recruit 200 patients |
| Readmission rates | 30 days from surgery | Readmission within 30 days of surgery |
| Length of stay | 30 days from surgery | Length of hospital admission |
Countries
Ghana, India, Philippines
Outcome results
None listed