NCT01034696

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2009

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

May 23, 2016

Status Verified

May 1, 2016

Enrollment Period

8 months

First QC Date

December 16, 2009

Last Update Submit

May 20, 2016

Conditions

SarcomaMelanoma

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Marsden Hospital

Sutton, Surrey, SM25PT, United Kingdom

Location

MeSH Terms

Conditions

SarcomaMelanoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dr John Williams

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 16, 2009

First Posted

December 17, 2009

Study Start

May 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

May 23, 2016

Record last verified: 2016-05

Locations

GB(1)