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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Royal Marsden NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01034696
First received: December 16, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  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:

U.S. FDA Resources

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) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with neuropathic pain. [ Designated as safety issue: No ]
  • Potential predictors of pain. The variables tested as potential risk factors will be age, tumour type, gender and treatment type. [ Designated as safety issue: No ]
  • 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. [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034696

Contacts
Contact: Dr John Williams 02078082954 john.williams@rmh.nhs.uk

Locations
United Kingdom
Royal Marsden Hospital Recruiting
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

No publications provided

Responsible Party: Dr John Williams, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01034696     History of Changes
Other Study ID Numbers: CCR3224
Study First Received: December 16, 2009
Last Updated: December 16, 2009
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on June 18, 2013