SarcomaNCT01034696
Pain Prevalence and Risk Factors Among Sarcoma/Melanoma Oncology Patients in an Outpatients Setting
An observational study of Sarcoma and Melanoma, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The primary objective of this research project is to estimate the number of patients with sarcoma or melanoma attending an outpatients clinic that are in pain or have unmet pain needs. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2009to Jan 2010
- 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: Participants attending sarcoma and melanoma out patients clinics at the Royal Marsden Hospital.
Who may be able to join
- Diagnosis of sarcoma or melanoma cancer
- Able to respond to an assessment in written English.
- Able to provide informed consent to participate in the study.
Who cannot join
- Patients whose health would be compromised by participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Prevalence and Risk Factors Amongst Sarcoma/Melanoma Oncology Outpatients. A Baseline, Cross Sectional Study Towards a Pain Free Hospital
The primary objective of this research project is to estimate the number of patients with sarcoma or melanoma attending an outpatients clinic that are in pain or have unmet pain needs.
- Medical subject headings
- Sarcoma, Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with significant pain and the proportion of patients with a negative score on the pain management index (PMI)
Secondary outcomes (3)
Proportion of patients with neuropathic pain.
Potential predictors of pain. The variables tested as potential risk factors will be age, tumour type, gender and treatment type.
We will also seek to identify potential predictors of pain intensity in patients that do have pain. In addition to the risk factors already mentioned above, duration and cause of pain will also be tested in this case as potential pain predictors.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startMay 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Dr John Williams, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034696
- Sponsor's protocol ID
- CCR3224
- Status last verified
- May 2016
- First submitted
- 16 Dec 2009
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Prevalence and Risk Factors Amongst Sarcoma/Melanoma Oncology Outpatients. A Baseline, Cross Sectional Study Towards a Pain Free Hospital
- ClinicalTrials.gov ID
- NCT01034696
- Acronym / sponsor ID
- CCR3224
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 17 Dec 2009 (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.
The primary objective of this research project is to estimate the number of patients with sarcoma or melanoma attending an outpatients clinic that are in pain or have unmet pain needs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants attending sarcoma and melanoma out patients clinics at the Royal Marsden Hospital.
Key inclusion criteria (3 listed)
- Diagnosis of sarcoma or melanoma cancer
- Able to respond to an assessment in written English.
- Able to provide informed consent to participate in the study.
Key exclusion criteria (1 listed)
- Patients whose health would be compromised by participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of patients with significant pain and the proportion of patients with a negative score on the pain management index (PMI)
3 secondary outcomes
Proportion of patients with neuropathic pain.
Potential predictors of pain. The variables tested as potential risk factors will be age, tumour type, gender and treatment type.
We will also seek to identify potential predictors of pain intensity in patients that do have pain. In addition to the risk factors already mentioned above, duration and cause of pain will also be tested in this case as potential pain predictors.
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 23 May 2016.
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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.
Dr John Williams principal investigator
Royal Marsden NHS Foundation Trust
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 Sarcoma and Melanoma, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 1 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 23 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 United Kingdom. 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?
The proportion of patients with significant pain and the proportion of patients with a negative score on the pain management index (PMI). 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 23 May 2016.