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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01034696
First Posted: December 17, 2009
Last Update Posted: May 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Royal Marsden NHS Foundation Trust
  Purpose
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.

Condition
Sarcoma Melanoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pain Prevalence and Risk Factors Amongst Sarcoma/Melanoma Oncology Outpatients. A Baseline, Cross Sectional Study Towards a Pain Free Hospital

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 250
Study Start Date: May 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants attending sarcoma and melanoma out patients clinics at the Royal Marsden Hospital.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034696


Locations
United Kingdom
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM25PT
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Dr John Williams Royal Marsden NHS Foundation Trust
  More Information

Responsible Party: Dr John Williams, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01034696     History of Changes
Other Study ID Numbers: CCR3224
First Submitted: December 16, 2009
First Posted: December 17, 2009
Last Update Posted: May 23, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Melanoma
Sarcoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Connective and Soft Tissue


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