Pain: Screen and Treat

NCT01716780 | Unknown Phase 3

• 1 other identifier: CCR3439
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

This study is looking at treating cancer pain in head and neck cancer. Patients are asked in outpatients to score their worst pain on a scale of 0 to 10 in the last 24 hours. Those with a pain score of 4 and above are randomised into the study. Patients are allocated to continue with their current care (control group) or to be reviewed by the pain/palliative care team (intervention group). At baseline questionnaires are completed on level of pain, type of pain, quality of life and anxiety/depression. Information is also collected on the analgesia they've used in the past month and basic health economics (GP/hospital visits related to pain management and treatment). Follow up in the trial is for 3 months and consists of questionnaires as above and further collection of information on analgesic usage and health economics.

Conditions

Head and Neck Cancer; Pain

Outcome Measures

Primary Outcomes (1)

• The change in pain score summarized from patient reports

  1 month, 2 months and 3 months

Secondary Outcomes (6)

• Impact of pain

  1 month, 2 months, 3 months

• Adequacy of pain treatment

  1 month, 2 months and 3 months

• Quality of life

  1 month, 2 months and 3 months

• Patient satisfaction

  1 month, 2 months and 3 months

• Anxiety and depression

  1 month, 2 months and 3 months

Study Arms (2)

Routine care

NO INTERVENTION

Patients allocated to the "control group" will undergo their 'usual care'; they will be given pain medication when they specifically request it or when their oncology doctor/ nurse or GP considers it appropriate to prescribe it, either at the oncology clinic visit or at any time during the course of the study.

Intervention

EXPERIMENTAL

Patients allocated to the "intervention group" will be reviewed by the pain/palliative care team and will undergo prospective, proactive, integrated, structured pain treatment according to recent guidelines on cancer pain care.

Other: Intervention

Interventions

Intervention OTHER

Patients allocated to the "intervention group" will undergo prospective, proactive, integrated, structured pain treatment according to recent guidelines on cancer pain care

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients attending head and neck oncology clinics
• Patients with a cancer diagnosis who are receiving anti cancer treatment or who have received anti cancer treatment
• Patients who score 4 or more on the Brief Pain Inventory numerical rating scale screening question 'worst pain in past 24 hours'

You may not qualify if:

• age below 18 years
• patients unable to respond to an English written assessment
• patients with medical conditions that could affect their mental function or level of consciousness such as stroke, or dementia
• patients who score \<4 on the Brief Pain Inventory numerical rating scale screening question
• patients already under the care of a pain/palliative care service

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Pain

Interventions

Methods

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• John E Williams

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr John Williams

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: October 30, 2012
• Study Start: January 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 30, 2012

Record last verified: 2012-10

Locations

GB (1)