Pain: Screen and Treat

NCT ID: NCT01716780

Last Updated: 2012-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Head and Neck Cancer Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Intervention

Intervention Type OTHER

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

Interventions

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Intervention

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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RMH R&D

Dr John Williams

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John E Williams

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

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Royal Marsden Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CCR3439

Identifier Type: -

Identifier Source: org_study_id