Pain: Screen and Treat

Pain Clinical Trial

Official title:

Towards a Pain Free Hospital: Effect and Cost Effectiveness of Routine Screening and Treatment for Pain in Head and Neck Oncology Outpatients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01716780
• Other study ID #: CCR3439
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 12, 2012
• Last updated: October 25, 2012
• Start date: January 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health ResearchUnited Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 156
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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'

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Pain

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Royal Marsden Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in pain score summarized from patient reports		1 month, 2 months and 3 months	No
Secondary	Impact of pain	Measured by the brief pain inventory questionnaire	1 month, 2 months, 3 months	No
Secondary	Adequacy of pain treatment	Using Pain Management Index, calculated from BPI and WHO ladder	1 month, 2 months and 3 months	No
Secondary	Quality of life	Assessed using the EQ-5D questionnaire	1 month, 2 months and 3 months	No
Secondary	Patient satisfaction	Likert scale	1 month, 2 months and 3 months	No
Secondary	Anxiety and depression	Assessed using the Hospital anxiety and depression questionnaire	1 month, 2 months and 3 months	No
Secondary	Treatment costs	Information collected on analgesic usage and contact with healthcare professionals for pain management purposes	1 month, 2 months and 3 months	No