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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014