Overview

This trial is active, not recruiting.

Conditions head and neck cancer, pain
Treatment intervention
Phase phase 3
Sponsor Royal Marsden NHS Foundation Trust
Collaborator National Institute for Health Research, United Kingdom
Start date January 2011
End date July 2012
Trial size 156 participants
Trial identifier NCT01716780, CCR3439

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(No Intervention)
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)
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
Patients allocated to the "intervention group" will undergo prospective, proactive, integrated, structured pain treatment according to recent guidelines on cancer pain care

Primary Outcomes

Measure
The change in pain score summarized from patient reports
time frame: 1 month, 2 months and 3 months

Secondary Outcomes

Measure
Impact of pain
time frame: 1 month, 2 months, 3 months
Adequacy of pain treatment
time frame: 1 month, 2 months and 3 months
Quality of life
time frame: 1 month, 2 months and 3 months
Patient satisfaction
time frame: 1 month, 2 months and 3 months
Anxiety and depression
time frame: 1 month, 2 months and 3 months
Treatment costs
time frame: 1 month, 2 months and 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Towards a Pain Free Hospital: Effect and Cost Effectiveness of Routine Screening and Treatment for Pain in Head and Neck Oncology Outpatients
Principal investigator John E Williams
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Royal Marsden NHS Foundation Trust.