CancerNCT02775825
Quality of the End of Life Care
An observational study of Cancer, run by National Guard Health Affairs at 1 site in Saudi Arabia.
Trial summary
End-of life care is one of the principle components of cancer care. Measurement of the quality of care provided for end-of-life cancer patients is an important issue. Recently there has been an increased emphasis on measuring and monitoring the quality of cancer care for the purpose of improving clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer
- What is being tested?
- survey
- How many people
- 180 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Oct 2015to Mar 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with advanced cancer defined as patients who are 18 years or older with stage IV or metastatic disease at the last month of their life.
Who may be able to join
- Documented confirmed cancer diagnosis.
- 18 year or older.
- Patients with advanced cancer (stage IV or with metastasis).
- Any hospital admission within the last 30 days.
Who cannot join
- Cancer patients admitted under care of other specialties other than oncology.
- Patients who had a major surgery within one month of death, which required admission for more than 1 day under general anesthesia.
- Patients who were following with other hospitals transferred and died within 3 days of admission.
- Cancer diagnosis was made only on death certificate with no prior cancer diagnosis.
- Patient died outside hospital.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abdul Aziz Medical City for National Guard
Riyadh
About this study
Official title: Quality of the End of Life Care for Adult Patients With Advanced Cancer in Saudi Arabia
End-of life care is one of the principle components of cancer care. Measurement of the quality of care provided for end-of-life cancer patients is an important issue. Recently there has been an increased emphasis on measuring and monitoring the quality of cancer care for the purpose of improving clinical practice. Despite increasing attention paid to end-of-life care in recent years, many studies have described difficulties in the final phase of life, including problems with access to hospice, inadequate symptom management, care giving burdens, care mismatched with patient preferences, and inappropriate resource use. Measuring quality of life is an important issue for monitoring clinical practice and improving outcome. Although patient assessment is the best quality measure, it is impractical to measure the quality of end-of-life care because of the difficulties of accurate prognostication for end-of-life and many patients are too ill to provide assessments. In contrast, several recent studies developed quality indicators (QIs) of palliative and end-of-life care, which assess the quality from existing sources such as administrative data or medical chart data.
Read the detailed description
Quality of care has been defined as the 'degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge'.The challenge remains, however, to define key indicators of quality of care, to link those indicators with health outcomes, and to establish reliable, valid, and timely measurements of the indicators.
The development of QIs is based on the assumption that there is available evidence or a consensus position that can be used to assess the quality of care provided. As many areas of health care interventions operate with a limited evidence base, it is often necessary to combine the existing evidence with consensus techniques; such techniques explore consensus among a group of experts to reach a final aggregate opinion, expert-based knowledge
A systematic review published in 2006 that reviewed literature and relevant websites from USA, Europe, Canada, and Australia concluded that there were limited tools to evaluate whether cancer patients receive effective supportive treatment. In response, the cancer-quality Assessing Symptoms Side Effects and Indicators of Supportive Treatment (ASSIST) measures were developed .These ninety two quality indicators (QIs) were developed for medical record abstraction using the RAND-UCLA QI development method; they cover assessment and treatment of pain and other symptoms as well as information and care planning. However there are a number of other indicators that can be studied these include intensive care unit (ICU) visit, Emergency (ER) visits and chemotherapy use close to death.
- Conditions
- Cancer
- Being tested
- survey
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the quality of care provided by oncology department to adult patients with advanced cancer in the last month of their life using The Cancer Quality-ASSIST QI (Assessing Symptoms Side Effects and Indicators of Supportive Treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startOct 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Guard Health Affairs
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775825
- Sponsor's protocol ID
- C15/003/R
- Status last verified
- May 2016
- First submitted
- 12 May 2016
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of the End of Life Care for Adult Patients With Advanced Cancer in Saudi Arabia
- ClinicalTrials.gov ID
- NCT02775825
- Acronym / sponsor ID
- C15/003/R
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- National Guard Health AffairsOther government
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 18 May 2016 (estimated)
- 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.
End-of life care is one of the principle components of cancer care. Measurement of the quality of care provided for end-of-life cancer patients is an important issue. Recently there has been an increased emphasis on measuring and monitoring the quality of cancer care for the purpose of improving clinical practice. Despite increasing attention paid to end-of-life care in recent years, many studies have described difficulties in the final phase of life, including problems with access to hospice, inadequate symptom management, care giving burdens, care mismatched with patient preferences, and inappropriate resource use. Measuring quality of life is an important issue for monitoring clinical practice and improving outcome. Although patient assessment is the best quality measure, it is impractical to measure the quality of end-of-life care because of the difficulties of accurate prognostication for end-of-life and many patients are too ill to provide assessments. In contrast, several recent studies developed quality indicators (QIs) of palliative and end-of-life care, which assess the quality from existing sources such as administrative data or medical chart data.
Detailed description
Quality of care has been defined as the 'degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge'.The challenge remains, however, to define key indicators of quality of care, to link those indicators with health outcomes, and to establish reliable, valid, and timely measurements of the indicators.
The development of QIs is based on the assumption that there is available evidence or a consensus position that can be used to assess the quality of care provided. As many areas of health care interventions operate with a limited evidence base, it is often necessary to combine the existing evidence with consensus techniques; such techniques explore consensus among a group of experts to reach a final aggregate opinion, expert-based knowledge
A systematic review published in 2006 that reviewed literature and relevant websites from USA, Europe, Canada, and Australia concluded that there were limited tools to evaluate whether cancer patients receive effective supportive treatment. In response, the cancer-quality Assessing Symptoms Side Effects and Indicators of Supportive Treatment (ASSIST) measures were developed .These ninety two quality indicators (QIs) were developed for medical record abstraction using the RAND-UCLA QI development method; they cover assessment and treatment of pain and other symptoms as well as information and care planning. However there are a number of other indicators that can be studied these include intensive care unit (ICU) visit, Emergency (ER) visits and chemotherapy use close to death.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with advanced cancer defined as patients who are 18 years or older with stage IV or metastatic disease at the last month of their life.
Key inclusion criteria (4 listed)
- Documented confirmed cancer diagnosis.
- 18 year or older.
- Patients with advanced cancer (stage IV or with metastasis).
- Any hospital admission within the last 30 days.
Key exclusion criteria (5 listed)
- Cancer patients admitted under care of other specialties other than oncology.
- Patients who had a major surgery within one month of death, which required admission for more than 1 day under general anesthesia.
- Patients who were following with other hospitals transferred and died within 3 days of admission.
- Cancer diagnosis was made only on death certificate with no prior cancer diagnosis.
- Patient died outside hospital.
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 |
|---|---|---|
| survey | Other | – |
Primary outcome
To measure the quality of care provided by oncology department to adult patients with advanced cancer in the last month of their life using The Cancer Quality-ASSIST QI (Assessing Symptoms Side Effects and Indicators of Supportive Treatment
Time frame: 6 months
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 19 May 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by National Guard Health Affairs at 1 site in Saudi Arabia.
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 4 inclusion and 5 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 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. 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?
To measure the quality of care provided by oncology department to adult patients with advanced cancer in the last month of their life using The Cancer Quality-ASSIST QI (Assessing Symptoms Side Effects and Indicators of Supportive Treatment (time frame: 6 months). 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 19 May 2016.