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Pain: Screen and Treat

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
RMH R&D, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01716780
First received: September 12, 2012
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Head and Neck Cancer
Pain
 Other: Intervention
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • The change in pain score summarized from patient reports [ Time Frame: 1 month, 2 months and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impact of pain [ Time Frame: 1 month, 2 months, 3 months ] [ Designated as safety issue: No ]
    Measured by the brief pain inventory questionnaire

  • Adequacy of pain treatment [ Time Frame: 1 month, 2 months and 3 months ] [ Designated as safety issue: No ]
    Using Pain Management Index, calculated from BPI and WHO ladder

  • Quality of life [ Time Frame: 1 month, 2 months and 3 months ] [ Designated as safety issue: No ]
    Assessed using the EQ-5D questionnaire

  • Patient satisfaction [ Time Frame: 1 month, 2 months and 3 months ] [ Designated as safety issue: No ]
    Likert scale

  • Anxiety and depression [ Time Frame: 1 month, 2 months and 3 months ] [ Designated as safety issue: No ]
    Assessed using the Hospital anxiety and depression questionnaire

  • Treatment costs [ Time Frame: 1 month, 2 months and 3 months ] [ Designated as safety issue: No ]
    Information collected on analgesic usage and contact with healthcare professionals for pain management purposes


Enrollment: 156
Study Start Date: January 2011
Estimated Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716780

Locations
United Kingdom
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: John E Williams Royal Marsden NHS Foundation Trust
  More Information

No publications provided

Responsible Party: RMH R&D, Dr John Williams, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01716780     History of Changes
Other Study ID Numbers: CCR3439
Study First Received: September 12, 2012
Last Updated: October 25, 2012
Health Authority: United Kingdom: National Institute for Health Research
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013