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

Completed

• Conditions: Surgery; Malnutrition; Cancer
• Interventions: Other: Malnutrition screening

• Registration Number: NCT04448041
• Lead Sponsor: University of Edinburgh

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-11
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-25
• Study Start: 2020-09-07
• Primary Completion: 2021-06-30
• Study Completion: 2021-11-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
India	Malnutrition screening	-
Zambia	Malnutrition screening	-
Ghana	Malnutrition screening	-
Philippines	Malnutrition screening	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Re-operation rate	30 days from surgery	Re-operation within 30 days of surgical procedure
30-day complication rate	30 days from surgery	Defined with by Clavien-Dindo grade III or IV
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
Readmission rates	30 days from surgery	Readmission within 30 days of surgery
Recruitment rate	Through study duration, up to one year	Time taken to recruit 200 patients
Length of stay	30 days from surgery	Length of hospital admission

Trial Locations

Locations (11)

AIIMS; 🇮🇳 Rishīkesh, India

Philippine General Hospital (UP-PGH); 🇵🇭 Manila, Philippines

Tamale Teaching Hospital; 🇬🇭 Tamale, Ghana

Tata medical Centre; 🇮🇳 Kolkata, India

Padhar Hospital; 🇮🇳 Padhar, India

CMC Ludhiana; 🇮🇳 Ludhiana, India

Cape Coast Teaching Hospital; 🇬🇭 Cape Coast, Ghana

Medical Center; 🇵🇭 Manila, Philippines

Rizal Medical Center; 🇵🇭 Manila, Philippines

The Medical City Hospital; 🇵🇭 Manila, Philippines

Christian Medical College; 🇮🇳 Vellore, India