Pain: Screen and Treat

Phase 3

• Conditions: Pain; Head and Neck Cancer
• Interventions: Other: Intervention

• Registration Number: NCT01716780
• Lead Sponsor: Royal Marsden NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-07
• Study First Submitted: 2012-09-12
• Status Verified: 2012-10
• Study Completion: 2012-10
• Study First Submitted QC: 2012-10-25
• Last Update Submitted: 2012-10-25
• Study First Posted: 2012-10-30
• Last Update Posted: 2012-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 156

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	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.

Primary Outcome Measures

Name	Time	Method
The change in pain score summarized from patient reports	1 month, 2 months and 3 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Royal Marsden Hospital; 🇬🇧 London, United Kingdom