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Pain: Screen and Treat

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01716780
Enrollment
156
Registered
2012-10-30
Start date
2011-01-31
Completion date
2012-10-31
Last updated
2012-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Pain

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.

Interventions

OTHERIntervention

Patients allocated to the intervention group will undergo prospective, proactive, integrated, structured pain treatment according to recent guidelines on cancer pain care

Sponsors

National Institute for Health Research, United Kingdom
CollaboratorOTHER_GOV
Royal Marsden NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The change in pain score summarized from patient reports1 month, 2 months and 3 months

Secondary

MeasureTime frameDescription
Adequacy of pain treatment1 month, 2 months and 3 monthsUsing Pain Management Index, calculated from BPI and WHO ladder
Quality of life1 month, 2 months and 3 monthsAssessed using the EQ-5D questionnaire
Impact of pain1 month, 2 months, 3 monthsMeasured by the brief pain inventory questionnaire
Anxiety and depression1 month, 2 months and 3 monthsAssessed using the Hospital anxiety and depression questionnaire
Treatment costs1 month, 2 months and 3 monthsInformation collected on analgesic usage and contact with healthcare professionals for pain management purposes
Patient satisfaction1 month, 2 months and 3 monthsLikert scale

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026