Pain: Screen and Treat
Primary Purpose
Head and Neck Cancer, Pain
Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Intervention
Sponsored by
About this trial
This is an interventional health services research trial for Head and Neck Cancer
Eligibility Criteria
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
Sites / Locations
- Royal Marsden Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Routine care
Intervention
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The change in pain score summarized from patient reports
Secondary Outcome Measures
Impact of pain
Measured by the brief pain inventory questionnaire
Adequacy of pain treatment
Using Pain Management Index, calculated from BPI and WHO ladder
Quality of life
Assessed using the EQ-5D questionnaire
Patient satisfaction
Likert scale
Anxiety and depression
Assessed using the Hospital anxiety and depression questionnaire
Treatment costs
Information collected on analgesic usage and contact with healthcare professionals for pain management purposes
Full Information
NCT ID
NCT01716780
First Posted
September 12, 2012
Last Updated
October 25, 2012
Sponsor
Royal Marsden NHS Foundation Trust
Collaborators
National Institute for Health Research, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT01716780
Brief Title
Pain: Screen and Treat
Official Title
Towards a Pain Free Hospital: Effect and Cost Effectiveness of Routine Screening and Treatment for Pain in Head and Neck Oncology Outpatients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
October 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal Marsden NHS Foundation Trust
Collaborators
National Institute for Health Research, United Kingdom
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Pain
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Routine care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intervention
Intervention Description
Patients allocated to the "intervention group" will undergo prospective, proactive, integrated, structured pain treatment according to recent guidelines on cancer pain care
Primary Outcome Measure Information:
Title
The change in pain score summarized from patient reports
Time Frame
1 month, 2 months and 3 months
Secondary Outcome Measure Information:
Title
Impact of pain
Description
Measured by the brief pain inventory questionnaire
Time Frame
1 month, 2 months, 3 months
Title
Adequacy of pain treatment
Description
Using Pain Management Index, calculated from BPI and WHO ladder
Time Frame
1 month, 2 months and 3 months
Title
Quality of life
Description
Assessed using the EQ-5D questionnaire
Time Frame
1 month, 2 months and 3 months
Title
Patient satisfaction
Description
Likert scale
Time Frame
1 month, 2 months and 3 months
Title
Anxiety and depression
Description
Assessed using the Hospital anxiety and depression questionnaire
Time Frame
1 month, 2 months and 3 months
Title
Treatment costs
Description
Information collected on analgesic usage and contact with healthcare professionals for pain management purposes
Time Frame
1 month, 2 months and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John E Williams
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Marsden Hospital
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
12. IPD Sharing Statement
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Pain: Screen and Treat
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