An observational study in Neoplasms, Bereavement and Quality of Life, sponsored by University of Bergen. Completed at 20 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by University of Bergen · Observational
Providing high quality care for dying patients and their families is very important. One way one can assess the care provided is to ask bereaved relatives to complete a questionnaire after their family member has died. The questionnaire can ask about their experiences and their thoughts about the care provided to their family member.
One such questionnaire is the 'Care Of the Dying Evaluation' (or CODE). CODE has been developed with the help and support of bereaved relatives and has been used extensively within the United Kingdom. In this project the investigators want to use the CODE questionnaire to look at bereaved relatives' views about care provided in seven different countries within Europe and Latin America. In the first part of the project CODE was translated into the main language of each country. Volunteers and bereaved relatives in each country were asked to give feedback about whether CODE was easy to understand, sensitive, and easy to complete. Based on the feedback a common version of CODE that is suitable for use across all the countries was developed.
In the next phase of the project, relatives who have recently experienced a bereavement where one of their family members has died from cancer in a hospital, will be invited to complete the CODE questionnaire about two months after the patient's death. The relatives may complete CODE on paper, using a computer, or by interview. The aim is to have 100 completed CODE questionnaires from each of the seven countries. The data from the questionnaires will be used to make a report on the current quality of care for dying cancer patients in hospitals across the seven countries. It will also be possible to compare the care between the countries and identify areas needing improvement.
In the next phase of the project, health care professionals, researchers and bereaved relatives together will use their knowledge and experience to find effective ways to improve the weak areas identified, and assess the results of putting these changes into practice.
ABSTRACT
Background: In order to ensure the highest quality of care is provided for dying patients and their families, one needs to first be able to robustly evaluate the current quality of care. One identified method is to assess this from the user-perspective by conducting bereaved relatives' surveys. 'Care Of the Dying Evaluation' (CODE) is a recognised, validated post-bereavement questionnaire which has been extensively used within the United Kingdom. The ERANet-LAC CODE project aims to use CODE in a wider international context. In Work Package 1 of the project, CODE will be translated and pilot tested in volunteers and bereaved relatives in the partner countries. Using a consensus procedure, a final version of the international CODE (i-CODE) questionnaire will be developed.
Aims: The present project (Work Package 2) aims to advance the international evidence in care for dying cancer patients by undertaking an observational study of bereaved relatives' views across seven participating countries. The overall aims of Work Package 2 (WP2) are to:
Methods: Bereaved adult relatives, to adult cancer patients who had an 'expected' death in hospital, will be approached face to face, by telephone or in writing and invited to complete the CODE questionnaire. The CODE questionnaire pack will be sent out 6-8 weeks after bereavement. CODE may be completed via self-completion paper questionnaire, via on-line questionnaire, or facilitated via a researcher using a tablet, telephone or face-to-face interview, according to what is feasible and acceptable in each country. The aim is 100 completed questionnaires per country. Basic demographics will be recorded for all potential participants and for the patients who died.
Analysis of results: Data will be analysed using SPSS and according to the CODE user guide, to present a common international report, individual country reports and cross-country comparisons. Data will be interpreted in the context of knowledge about the individual sites/countries.
Conclusions: The expected outcomes from WP2 are an international survey and cross-country comparisons about the current quality of care for dying cancer patients as perceived by bereaved people, including key areas where care needs to be improved. WP3 of the project will use the results of the international survey to implement changes to improve the care.
INTRODUCTION
The present project was proposed in response to the ERANet-LAC 2nd Joint Call on Research and Innovation and approved for funding under the European Commission's 7th framework program. The aim of the project is to inform and develop an evidence based approach to systematically standardize assessment and care of dying cancer patients, using relative generated outcomes. The project will be conducted in four European and three South American countries three years starting from January 2017. The project contains three Work Packages (parts). This protocol describes the work to be undertaken in Work Package 2 (CODE International Survey).
BACKGROUND
The delivery of appropriate care for dying cancer patients remains a key medical, social, economic and political issue. However, the quality of care for the dying is diverse both within and between EU-LAC countries.
Based on the international evidence base, a set of core principles for care of the dying has been defined. These principles are applicable to the care of dying cancer patients, as well as other patients, worldwide.
In order to ensure the highest quality of care provisions, one needs to first be able to robustly evaluate the current quality of care. One method is to assess this from the user-perspective by conducting bereaved relatives' surveys.
'Care Of the Dying Evaluation' Questionnaire
One post-bereavement questionnaire is 'Care Of the Dying Evaluation' (CODE). This is a 42-item self-completion questionnaire, developed within the UK, and focused on the quality of care and the level of support provided to individuals and their families in the last days of life and the immediate post-bereavement period.
CODE has been used and validated with bereaved relatives, including undertaking cognitive 'think aloud' interviews to assess face and content validity; assessing CODE's stability over time by conducting test-retest reliability analysis; and assessing the construct validity and internal consistency of CODE. Subsequently, CODE has been used across hospices, hospitals and community settings.
In Work Package 1 of the present project, CODE was translated from English into the main language of each partner country according to established international procedures, and pilot tested in volunteers and bereaved relatives to assure understanding and appropriate cultural adaptation. Based on feedback from the testing in each country, a common, international version of CODE (iCODE) has been established through a consensus procedure.
AIMS \& OBJECTIVES
The present project (Work Package 2) aims to advance the international evidence in care for dying patients by undertaking an observational study of bereaved relatives' views across seven participating countries, by use of the CODE questionnaire.
The overall aims of Work Package 2 (WP2) are:
METHODS
Study sites
The necessary number of hospitals caring for adult cancer patients will be recruited as study sites. The study will only be performed in institutions defined as hospitals
Recruitment
The relative / next-of-kin must be approached after the patient's death. The investigators will approach the person recorded as next-of-kin in the patient's hospital record.
Only one completed questionnaire will be included per deceased patient.
Recruitment will be done prospectively. The method of recruitment will be adapted as to what is feasible and in the individual country.
DATA COLLECTION
CODE International Survey
Data to be collected The CODE questionnaire is the common data collection tool of the study. CODE also includes demographic data. Information about the hospital stay will be included for all cases, as part of the inclusion procedure.
Method of data collection
The CODE questionnaire will be sent to the participants 6-8 weeks post bereavement, with on reminder. CODE International Survey was intended as a postal survey, but other data collection methods will also be accepted.
Sample estimation:
Minimum acceptable number of questionnaires per country is 100 (with this number, a 95% confidence interval will give a margin of error of +/- 10% of the primary outcome).
Data transfer
The electronic version and database for CODE for each country/language will be developed in Norway using the Corporate Surveyor software. The databases will be merged in Norway for the final common analyses.
A web survey of study sites will also be conducted.
DATA ANALYSIS
Data will be analysed using the R statistical package, using descriptive statistics (proportions (%) for categorical data; means and standard deviations for continuous parametric data and medians and interquartile range for continuous non-parametric data).
The dataset, anonymised at patient, site and country level, will be aggregated at international level to enable an international report. Results will be summarised in tabular and graphical format, as appropriate.
Free text comments will be analysed using qualitative methods (text condensation).
PROJECT MANAGEMENT AND WORK PLAN
All partners have signed the consortium agreement. The PIs are responsible for the CODE international survey in their respective countries. The group of PIs constitute the project General Assembly and decision-making body.
WP1 (Preparation and Piloting) ran from month 1 to month 7 of the project, i.e. from January to August 2017.
WP2 is designed to run from month 8 to month 22 of the project, i.e. from September 2017 to November 2018.
Time line and deliverables
Confirmation of ethical approval for CODE International Survey in each country: month 6 (July 2017) Web survey of institutions ready for use: month 6 (July 2017) Fully developed, tested and web-accessible data collection tools: month 6 (July 2017) i-CODE ready for use: month 7 (Aug 2017) Completed web survey of inclusion sites: month 10 (Nov 2017) Completed international survey with at least 600 completed CODE questionnaires: month 22 (Nov 2018) Report on CODE International Survey data: month 22 (Nov 2018)
SPONSORSHIP AND BUDGET
Financial support for the project was granted from national research funding agencies in the participating countries, except in the UK. The University of Liverpool, UK, takes part in the project as self-financed partner.
No commercial interests are involved in the study. No conflicts of interest have been declared. Participants receive no financial benefit for participation.
ETHICAL APPROVAL AND GOVERNANCE
The Project Lead (PI) for each country will seek the necessary approvals for CODE International Survey, from their local/regional ethics committee, and from their institutional review board as needed. All countries will need ethical approval for WP2.
All potential participants will be given a Participant Information Sheet detailing the aims of the study and informing that participation is fully voluntary.
PATIENT AND PUBLIC INVOLVEMENT Both volunteers and bereaved relatives will be deeply involved in developing i-CODE to be used for the international survey.
After the survey has been performed, bereaved relatives will be involved in the action planning on how to address the main areas of concern identified.
CONFIDENTIALITY AND DATA MANAGEMENT
The Project Lead for each country will preserve the confidentiality of participants taking part in the study. All data will be anonymised and individual participants will not be identifiable from published data.
All data will be stored on a secure, password protected research server. Data will be stored for up to five years after the completion of the project before being confidentially shredded or deleted.
DISSEMINATION AND PUBLICATIONS
A website for the project will be established.
Authorship will be defined according to the Vancouver Guidelines. National data may be published by the study group in each country.
The last project meeting with presentations and discussions of the project findings will be arranged as an open international conference.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's enrollment of 914 is above the median of 200 across 2,638 observational studies indexed under Neoplasms.
Browse Neoplasms studies →University of Bergen is the lead sponsor of 143 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Next-of-kin to cancer patient who died an expected death in hospital
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bereaved relatives after cancer deaths in hospitals
CODE (Care Of the Dying Evaluation) Questionnaire Item 30 Score for Relatives' Perception of How Much of the Time the Deceased Patient Was Treated With Dignity and Respect, by Nurses, and by Doctors
CODE (Care Of the Dying Evaluation) questionnaire, item 30: How much of the time was the deceased patient treated with dignity and respect, by nurses, and by doctors. Maximum obtainable score 4, minimum 0. The higher score, the better outcome.
Time frame: 6-8 weeks post bereavement
Number of Participants (Relatives) Answering "Yes" to CODE (Care Of the Dying Evaluation) Questionnaire Item 31: Were You Adequately Supported in the Patients' Last Days of Life?
CODE (Care Of the Dying Evaluation) questionnaire, item 31: Were you adequately supported in the patient's last days of life? Yes/no question. The higher percentage of relatives answering 'yes', the better outcome.
Time frame: 6-8 weeks post bereavement
Individual Items of CODE (Care Of the Dying Evaluation) Questionnaire.
Individual questionnaire items of the CODE (Care Of the Dying Evaluation) questionnaire. Maximum value 4, minimum value 0. The higher score, the better outcome.
Time frame: 6-8 weeks post bereavement
| Milestone | Bereaved Relatives |
|---|---|
| Started | 914 |
| Completed | 914 |
| Not completed | 0 |
CODE (Care Of the Dying Evaluation) questionnaire, item 30: How much of the time was the deceased patient treated with dignity and respect, by nurses, and by doctors. Maximum obtainable score 4, minimum 0. The higher score, the better outcome.
| score on a scale | Bereaved Relatives |
|---|---|
| CODE (Care Of the Dying Evaluation) Questionnaire Item 30 Score for Relatives' Perception of How Much of the Time the Deceased Patient Was Treated With Dignity and Respect, by Nurses, and by Doctors | 3.7 (3.6 to 3.7) |
CODE (Care Of the Dying Evaluation) questionnaire, item 31: Were you adequately supported in the patient's last days of life? Yes/no question. The higher percentage of relatives answering 'yes', the better outcome.
| Participants | Bereaved Relatives |
|---|---|
| Number of Participants (Relatives) Answering "Yes" to CODE (Care Of the Dying Evaluation) Questionnaire Item 31: Were You Adequately Supported in the Patients' Last Days of Life? | 788 |
Individual questionnaire items of the CODE (Care Of the Dying Evaluation) questionnaire. Maximum value 4, minimum value 0. The higher score, the better outcome.
Results for this outcome have not been posted.
Collected over One year, during the data collection.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bereaved Relatives | 0/914 (0%) | 0/914 (0%) | 0/914 (0%) |
| Age, Customized(Participants) | Bereaved Relatives |
|---|---|
| 18-29 years | 26 |
| 30-39 years | 95 |
| 40-49 years | 148 |
| 50-59 years | 241 |
| 60-69 years | 208 |
| 70-79 years | 150 |
| 80-89 years | 35 |
| Missing | 11 |
| Sex: Female, Male(Participants) | Bereaved Relatives |
|---|---|
| Female | 610 |
| Male | 304 |
| Race and Ethnicity Not Collected(Participants) | Bereaved Relatives |
|---|
| Region of Enrollment(Participants) | Bereaved Relatives |
|---|---|
| Argentina | 105 |
| Norway | 194 |
| Uruguay | 125 |
| Poland | 100 |
| Brazil | 105 |
| United Kingdom | 102 |
| Germany | 183 |
| Type of ward where the patient died(Participants) | Bereaved Relatives |
|---|---|
| Medical or surgical ward | 447 |
| Palliative care unit | 231 |
| Oncology ward | 119 |
| Intensive care unit | 69 |
| Emergency unit | 42 |
| Missing | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — The plan only includes sharing of data within the consortium.
Ran from Aug 2017 to primary completion in Dec 2018, 15 months.
Results were first posted in Oct 2021, 2 years 10 months after primary completion.
Of 1,098 non-industry observational studies under Neoplasms, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 227. This study's 15 months is below that.
Counting every sponsor, half of 1,246 studies reached it within 58 months; a quarter within 24 and three quarters within 210.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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