NCT04448041

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. 1.To identify and validate the most relevant nutritional screening tool for patients in LMICs undergoing surgery for cancer;
  2. 2.To identify a low cost sustainable nutritional intervention for patients in LMICs undergoing surgery for cancer;
  3. 3.To establish the feasibility of delivering a randomised trial of a sustainable nutritional intervention for patients in LMICs undergoing surgery for cancer.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
3 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 7, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

10 months

First QC Date

June 11, 2020

Last Update Submit

June 6, 2024

Conditions

MalnutritionSurgeryCancer

Keywords

MalnutritionScreening toolsCancer surgeryLow and middle-income countries (LMIC)

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • 30-day complication rate

    30 days from surgery

  • Length of stay

    30 days from surgery

  • Re-operation rate

    30 days from surgery

  • Quality of life following surgery (EQ-5D-5L / WHODAS questionnaire (36 item))

    30 days from surgery

  • Readmission rates

    30 days from surgery

  • +1 more secondary outcomes

Study Arms (4)

Ghana

Other: Malnutrition screening

India

Other: Malnutrition screening

Philippines

Other: Malnutrition screening

Zambia

Other: Malnutrition screening

Interventions

Malnutrition screeningOTHER

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

GhanaIndiaPhilippinesZambia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Cape Coast Teaching Hospital

Cape Coast, Ghana

Location

Tamale Teaching Hospital

Tamale, Ghana

Location

Tata medical Centre

Kolkata, India

Location

CMC Ludhiana

Ludhiana, India

Location

Padhar Hospital

Pādhar, India

Location

AIIMS

Rishikesh, India

Location

Christian Medical College

Vellore, India

Location

Medical Center

Manila, Philippines

Location

Philippine General Hospital (UP-PGH)

Manila, Philippines

Location

Rizal Medical Center

Manila, Philippines

Location

The Medical City Hospital

Manila, Philippines

Location

MeSH Terms

Conditions

MalnutritionNeoplasms

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Ewen Harrison

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 25, 2020

Study Start

September 7, 2020

Primary Completion

June 30, 2021

Study Completion

November 30, 2021

Last Updated

June 7, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

Derived anonymised data at the patient-level may be able to be made available for sharing

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

GH(2)IN(5)PH(4)