Pain: Screen and Treat

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Head and Neck Cancer
• Intervention / Treatment: Other: Intervention

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine care; 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.
Experimental: Intervention; 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; Patients allocated to the "intervention group" will undergo prospective, proactive, integrated, structured pain treatment according to recent guidelines on cancer pain care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change in pain score summarized from patient reports	1 month, 2 months and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of pain	Measured by the brief pain inventory questionnaire	1 month, 2 months, 3 months
Adequacy of pain treatment	Using Pain Management Index, calculated from BPI and WHO ladder	1 month, 2 months and 3 months
Quality of life	Assessed using the EQ-5D questionnaire	1 month, 2 months and 3 months
Patient satisfaction	Likert scale	1 month, 2 months and 3 months
Anxiety and depression	Assessed using the Hospital anxiety and depression questionnaire	1 month, 2 months and 3 months
Treatment costs	Information collected on analgesic usage and contact with healthcare professionals for pain management purposes	1 month, 2 months and 3 months

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust
• Collaborators: National Institute for Health Research, United Kingdom
• Investigators: Principal Investigator: John E Williams, Royal Marsden NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: September 12, 2012
• First Submitted That Met QC Criteria: October 25, 2012
• First Posted (Estimate): October 30, 2012

Study Record Updates

• Last Update Posted (Estimate): October 30, 2012
• Last Update Submitted That Met QC Criteria: October 25, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: CCR3439