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

Cancer Clinical Trial

— CRANE  

Official title:

A Cluster Randomised Feasibility Study of a Sustainable Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04448041
• Other study ID #: CRANE
• Status: Completed
• Start date: September 7, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: June 2024
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: November 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Cancer
• Malnutrition
• Surgery

Intervention

Other:
• Malnutrition screening
Primary comparison: Prevalence of malnutrition and impact on 30-day outcomes in patients undergoing surgery for cancer

Locations

Country	Name	City	State
Ghana	Cape Coast Teaching Hospital	Cape Coast
Ghana	Tamale Teaching Hospital	Tamale
India	Tata medical Centre	Kolkata
India	CMC Ludhiana	Ludhiana
India	Padhar Hospital	Padhar
India	AIIMS	Rishikesh
India	Christian Medical College	Vellore
Philippines	Medical Center	Manila
Philippines	Philippine General Hospital (UP-PGH)	Manila
Philippines	Rizal Medical Center	Manila
Philippines	The Medical City Hospital	Manila

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Countries where clinical trial is conducted

Ghana,  India,  Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of malnutrition	Malnutrition as measured using validated screening tools	Immediately prior to surgery
Primary	30-day mortality rate	Death within 30 days of surgical procedure	30 days from surgery
Secondary	30-day complication rate	Defined with by Clavien-Dindo grade III or IV	30 days from surgery
Secondary	Length of stay	Length of hospital admission	30 days from surgery
Secondary	Re-operation rate	Re-operation within 30 days of surgical procedure	30 days from surgery
Secondary	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
Secondary	Readmission rates	Readmission within 30 days of surgery	30 days from surgery
Secondary	Recruitment rate	Time taken to recruit 200 patients	Through study duration, up to one year