Pain Prevalence and Risk Factors Among Sarcoma/Melanoma Oncology Patients in an Outpatients Setting

May 20, 2016 updated by: Royal Marsden NHS Foundation Trust

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Sutton, Surrey, United Kingdom, SM25PT
        • Royal Marsden Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants attending sarcoma and melanoma out patients clinics at the Royal Marsden Hospital.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients whose health would be compromised by participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The proportion of patients with significant pain and the proportion of patients with a negative score on the pain management index (PMI)

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Principal Investigator: Dr John Williams, Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

December 16, 2009

First Submitted That Met QC Criteria

December 16, 2009

First Posted (ESTIMATE)

December 17, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 23, 2016

Last Update Submitted That Met QC Criteria

May 20, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR3224

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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