MalnutritionCRANENCT04448041
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
An observational study of Malnutrition and Surgery, run by University of Edinburgh at 11 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, Surgery, Cancer
- What is being tested?
- Malnutrition screening
- How many people
- 168 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 7 Sep 2020to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgery for cancer in four partner LMIC countries are eligible
Who may be able to join
- 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).
Who cannot join
- 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;
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
India5 sites
Tata medical Centre
Kolkata
CMC Ludhiana
Ludhiana
Padhar Hospital
Pādhar
AIIMS
Rishikesh
Christian Medical College
Vellore
Philippines4 sites
Medical Center
Manila
Philippine General Hospital (UP-PGH)
Manila
Rizal Medical Center
Manila
The Medical City Hospital
Manila
Ghana2 sites
Cape Coast Teaching Hospital
Cape Coast
Tamale Teaching Hospital
Tamale
About this study
Official title: 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).
- To identify and validate the most relevant nutritional screening tool for patients in LMICs undergoing surgery for cancer;
- To identify a low cost sustainable nutritional intervention for patients in LMICs undergoing surgery for cancer;
- To establish the feasibility of delivering a randomised trial of a sustainable nutritional intervention for patients in LMICs undergoing surgery for cancer.
Read more
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).
- Conditions
- Malnutrition, Surgery, Cancer
- Being tested
- Malnutrition screening
- Keywords
- Malnutrition, Screening tools, Cancer surgery, Low and middle-income countries (LMIC)
- Medical subject headings
- Malnutrition, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Malnutrition screeningOther
Primary comparison: Prevalence of malnutrition and impact on 30-day outcomes in patients undergoing surgery for cancer
| Study group | Role | What they receive |
|---|---|---|
| Ghana | Not described Receives: Other: Malnutrition screening | |
| India | Not described Receives: Other: Malnutrition screening | |
| Philippines | Not described Receives: Other: Malnutrition screening | |
| Zambia | Not described Receives: Other: Malnutrition screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of malnutrition
Malnutrition as measured using validated screening tools
Measured: Immediately prior to surgery
30-day mortality rate
Death within 30 days of surgical procedure
Measured: 30 days from surgery
Secondary outcomes (6)
30-day complication rate
Defined with by Clavien-Dindo grade III or IV
Measured: 30 days from surgery
Length of stay
Length of hospital admission
Measured: 30 days from surgery
Re-operation rate
Re-operation within 30 days of surgical procedure
Measured: 30 days from surgery
Quality of life following surgery (EQ-5D-5L / WHODAS questionnaire (36 item))
Short-term quality of life for patients following surgery
Measured: 30 days from surgery
Readmission rates
Readmission within 30 days of surgery
Measured: 30 days from surgery
Recruitment rate
Time taken to recruit 200 patients
Measured: Through study duration, up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start7 Sep 2020
- Primary completion30 Jun 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ewen Harrison, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448041
- Sponsor's protocol ID
- CRANE
- Acronym
- CRANE
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2020
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Derived anonymised data at the patient-level may be able to be made available for sharing
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomised Feasibility Study of a Sustainable Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
- ClinicalTrials.gov ID
- NCT04448041
- Acronym / sponsor ID
- CRANE / CRANE
- Conditions
- Malnutrition, Surgery, Cancer
- Keywords
- Malnutrition, Screening tools, Cancer surgery, Low and middle-income countries (LMIC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- To identify and validate the most relevant nutritional screening tool for patients in LMICs undergoing surgery for cancer;
- To identify a low cost sustainable nutritional intervention for patients in LMICs undergoing surgery for cancer;
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ghana | – | Other: Malnutrition screening |
| India | – | Other: Malnutrition screening |
| Philippines | – | Other: Malnutrition screening |
| Zambia | – | Other: Malnutrition screening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery for cancer in four partner LMIC countries are eligible
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Malnutrition screeningPrimary comparison: Prevalence of malnutrition and impact on 30-day outcomes in patients undergoing surgery for cancer | Other | Ghana, India, Philippines, Zambia |
Primary outcome
Prevalence of malnutrition
Time frame: Immediately prior to surgery
Malnutrition as measured using validated screening tools
30-day mortality rate
Time frame: 30 days from surgery
Death within 30 days of surgical procedure
6 secondary outcomes
30-day complication rate
Time frame: 30 days from surgery
Length of stay
Time frame: 30 days from surgery
Re-operation rate
Time frame: 30 days from surgery
Quality of life following surgery (EQ-5D-5L / WHODAS questionnaire (36 item))
Time frame: 30 days from surgery
Readmission rates
Time frame: 30 days from surgery
Recruitment rate
Time frame: Through study duration, up to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: Yes. Derived anonymised data at the patient-level may be able to be made available for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewen Harrison principal investigator
University of Edinburgh
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Surgery, run by University of Edinburgh at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in India, Philippines, Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of malnutrition (time frame: Immediately prior to surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.