Pain: Screen and Treat
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|ClinicalTrials.gov Identifier: NCT01716780|
Recruitment Status : Unknown
Verified October 2012 by RMH R&D, Royal Marsden NHS Foundation Trust.
Recruitment status was: Active, not recruiting
First Posted : October 30, 2012
Last Update Posted : October 30, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Pain||Other: Intervention||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|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 Start Date :||January 2011|
|Actual Primary Completion Date :||July 2012|
|Estimated Study Completion Date :||October 2012|
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.
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.
Patients allocated to the "intervention group" will undergo prospective, proactive, integrated, structured pain treatment according to recent guidelines on cancer pain care
- The change in pain score summarized from patient reports [ Time Frame: 1 month, 2 months and 3 months ]
- Impact of pain [ Time Frame: 1 month, 2 months, 3 months ]Measured by the brief pain inventory questionnaire
- Adequacy of pain treatment [ Time Frame: 1 month, 2 months and 3 months ]Using Pain Management Index, calculated from BPI and WHO ladder
- Quality of life [ Time Frame: 1 month, 2 months and 3 months ]Assessed using the EQ-5D questionnaire
- Patient satisfaction [ Time Frame: 1 month, 2 months and 3 months ]Likert scale
- Anxiety and depression [ Time Frame: 1 month, 2 months and 3 months ]Assessed using the Hospital anxiety and depression questionnaire
- Treatment costs [ Time Frame: 1 month, 2 months and 3 months ]Information collected on analgesic usage and contact with healthcare professionals for pain management purposes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716780
|Royal Marsden Hospital|
|London, United Kingdom, SW3 6JJ|
|Principal Investigator:||John E Williams||Royal Marsden NHS Foundation Trust|