Clinical trial NCT04448041: CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Official title: A Cluster Randomised Feasibility Study of a Sustainable Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Surgery
Cancer
Keywords: Malnutrition
Screening tools
Cancer surgery
Low and middle-income countries (LMIC)
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgery for cancer in four partner LMIC countries are eligible

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).


Eligibility criteria: 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;

Primary outcomes:
measure: Prevalence of malnutrition
timeFrame: Immediately prior to surgery
measure: 30-day mortality rate
timeFrame: 30 days from surgery
Secondary outcomes:
measure: 30-day complication rate
timeFrame: 30 days from surgery
measure: Length of stay
timeFrame: 30 days from surgery
measure: Re-operation rate
timeFrame: 30 days from surgery
measure: Quality of life following surgery (EQ-5D-5L / WHODAS questionnaire (36 item))
timeFrame: 30 days from surgery
measure: Readmission rates
timeFrame: 30 days from surgery
measure: Recruitment rate
timeFrame: Through study duration, up to one year
Other outcomes:
Locations:
city: Cape Coast
country: Ghana
facility: Cape Coast Teaching Hospital
city: Tamale
country: Ghana
facility: Tamale Teaching Hospital
city: Kolkata
country: India
facility: Tata medical Centre
city: Ludhiana
country: India
facility: CMC Ludhiana
city: Padhar
country: India
facility: Padhar Hospital
city: Rishīkesh
country: India
facility: AIIMS
city: Vellore
country: India
facility: Christian Medical College
city: Manila
country: Philippines
facility: Medical Center
city: Manila
country: Philippines
facility: Philippine General Hospital (UP-PGH)
city: Manila
country: Philippines
facility: Rizal Medical Center
city: Manila
country: Philippines
facility: The Medical City Hospital
Study officials:
affiliation: University of Edinburgh
name: Ewen Harrison
role: PRINCIPAL_INVESTIGATOR
References: