Head and Neck CancerPhase 3NCT01716780
Pain: Screen and Treat
A Phase 3 study testing Intervention in people with Head and Neck Cancer and Pain, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Pain
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2011to Oct 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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'
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Towards a Pain Free Hospital: Effect and Cost Effectiveness of Routine Screening and Treatment for Pain in Head and Neck Oncology Outpatients
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.
- Conditions
- Head and Neck Cancer, Pain
- Being tested
- Intervention
- Medical subject headings
- Head and Neck Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
Patients allocated to the "intervention group" will undergo prospective, proactive, integrated, structured pain treatment according to recent guidelines on cancer pain care
| Study group | Role | What they receive |
|---|---|---|
| Routine care | 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. |
| Intervention | 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. Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in pain score summarized from patient reports
Measured: 1 month, 2 months and 3 months
Secondary outcomes (6)
Impact of pain
Measured by the brief pain inventory questionnaire
Measured: 1 month, 2 months, 3 months
Adequacy of pain treatment
Using Pain Management Index, calculated from BPI and WHO ladder
Measured: 1 month, 2 months and 3 months
Quality of life
Assessed using the EQ-5D questionnaire
Measured: 1 month, 2 months and 3 months
Patient satisfaction
Likert scale
Measured: 1 month, 2 months and 3 months
Anxiety and depression
Assessed using the Hospital anxiety and depression questionnaire
Measured: 1 month, 2 months and 3 months
Treatment costs
Information collected on analgesic usage and contact with healthcare professionals for pain management purposes
Measured: 1 month, 2 months and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startJan 2011
- Primary completionJul 2012
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Principal investigator, RMH R&D, Royal Marsden NHS Foundation Trust
- Investigators
- John E Williams, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716780
- Sponsor's protocol ID
- CCR3439
- Status last verified
- Oct 2012
- First submitted
- 12 Sep 2012
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards a Pain Free Hospital: Effect and Cost Effectiveness of Routine Screening and Treatment for Pain in Head and Neck Oncology Outpatients
- ClinicalTrials.gov ID
- NCT01716780
- Acronym / sponsor ID
- CCR3439
- Conditions
- Head and Neck Cancer, Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Jan 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (estimated)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine care | 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. |
| Intervention | Experimental | Other: InterventionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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'
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionPatients allocated to the "intervention group" will undergo prospective, proactive, integrated, structured pain treatment according to recent guidelines on cancer pain care | Other | Intervention |
Primary outcome
The change in pain score summarized from patient reports
Time frame: 1 month, 2 months and 3 months
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John E Williams principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intervention in people with Head and Neck Cancer and Pain, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in pain score summarized from patient reports (time frame: 1 month, 2 months and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2012.