Pain: Screen and Treat

Study Overview
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Brief Summary
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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.

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

Conditions
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Head and Neck Cancer, Pain

Intervention / Treatment
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* Other: Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine care<br>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<br>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<br>* Patients allocated to the intervention group will undergo prospective, proactive, integrated, structured pain treatment according to recent guidelines on cancer pain care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |