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

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).

Study Overview

• Status: Unknown
• Conditions: Cancer; Malnutrition; Surgery
• Intervention / Treatment: Other: Malnutrition screening

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery for cancer in four partner LMIC countries are eligible

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ghana	Other: Malnutrition screening; Primary comparison: Prevalence of malnutrition and impact on 30-day outcomes in patients undergoing surgery for cancer
India	Other: Malnutrition screening; Primary comparison: Prevalence of malnutrition and impact on 30-day outcomes in patients undergoing surgery for cancer
Philippines	Other: Malnutrition screening; Primary comparison: Prevalence of malnutrition and impact on 30-day outcomes in patients undergoing surgery for cancer
Zambia	Other: Malnutrition screening; Primary comparison: Prevalence of malnutrition and impact on 30-day outcomes in patients undergoing surgery for cancer

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Edinburgh

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2020
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): November 1, 2021

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (ACTUAL): June 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 22, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Malnutrition; Cancer surgery; Screening tools; Low and middle-income countries (LMIC)
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: CRANE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Derived anonymised data at the patient-level may be able to be made available for sharing
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No