PainHNCNCT03089736
Pain Related to Head and Neck Cancer (HNC); Implementation and Evaluation of Self-care Measure Due to the Same Illness
A study testing Education, Self Care and Treatment as usual (TAU) in people with Pain and Head and Neck Cancer, run by Linkoeping University.
Trial summary
The purpose of this study is to evaluate the effect of individual education and individual self-care measures on pain intensity, perceived health, mood and sleep during and after treatment with radiotherapy for head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Head and Neck Cancer
- What is being tested?
- Education, Self Care and Treatment as usual (TAU)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 19 Mar 2017
- Phase
- Interventional
- 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
- All HNC patients who went through RT and were referred to the Pain and Rehabilitation Centre at the University Hospital (Linköping, Sweden) were invited to participate in the study which run from January 2015 - March 2017.
- -
Who cannot join
- Non Swedish speaking individuals, severe social and/or psychological disorders, severe cognitive conditions,other serious medical conditions.
- -
About this study
Official title: Pain Related to Head and Neck Cancer (HNC); Implementation and Evaluation of Self-care Measure Due to the Same Illness During Radiotherapy (RT)
The purpose of this study is to evaluate the effect of individual education and individual self-care measures on pain intensity, perceived health, mood and sleep during and after treatment with radiotherapy for head and neck cancer.
Read the detailed description
The purpose of this study is to evaluate the effect of individual education and individual self-care measures on pain intensity, perceived health, mood and sleep during and after treatment with radiotherapy for head and neck cancer
- Conditions
- Pain, Head and Neck Cancer
- Being tested
- Education, Self Care, Treatment as usual (TAU)
- Keywords
- Pain, Head and neck cancer, depression, anxiety, health, catastrophizing
- Medical subject headings
- Pain, Head and Neck Neoplasms, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Six education areas was offered: pain and pain physiology, pain medication, side effects and prevention of side effects, abuse of medications, sleep advice and advice on anxiety.
Self CareBehavioural
The following instructions on self-care for pain relief: apply ice or crushed ice in the oral cavity, lubricating and antiseptic mouth rinses, pain relieving gel, tongue movements and gaps exercises. Prevention of dryness in the mouth and throat; saliva stimulants and saliva substitute agents in different preparations, increased measures of good oral hygiene. Physical activities and regular rest once to several times per day. Sleep restriction and measures to treat sleep disorders.
pharmacological treatment + advices
| Study group | Role | What they receive |
|---|---|---|
| TAU + Education and self care | Experimental | Treatment as usual (TAU; i.e. pharmacological treatments and advices) + structured education + instructions on self care Receives: Behavioral: Education; Behavioral: Self Care; Other: Treatment as usual (TAU) |
| Treatment as usual (TAU) | Other | Treatment as usual (TAU; i.e. pharmacological treatments and advices) Receives: Other: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain intensity
Pain intensity the actual day using a numeric rating scale.
Measured: Change from baseline pain intensity at 20 weeks
Change in Pain Interference
Pain interference the actual day using a numeric rating scale
Measured: Change from baseline pain interference at 20 weeks
Change in Perceived health index
Perceived health according to the index based on five dimensions of European Quality of Life instrument (EQ-5D index)
Measured: Change from baseline EQ-5D index at 20 weeks
Change in Perceived health scale
Perceived health according to the visual analgue scale of European Quality of Life instrument (EQ-VAS)
Measured: Change from baseline EQ-VAS at 20 weeks
Secondary outcomes (3)
Change in depression
Depression scale of Hospital and Depression Scale (HADS)
Measured: Change from baseline depression at 20 weeks
Change in anxiety
Anxiety scale of Hospital and Depression Scale (HADS)
Measured: Change from baseline anxiety at 20 weeks
Change in catastrophizing
Total score of Pain Catastrophizing scale
Measured: Change from baseline catastrophizing at 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start1 Jan 2015
- Primary completion31 Dec 2016
- Study completion19 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bjorn Gerdle, Linkoeping University
- Investigators
- Bjorn Gerdle, Professor MD, Principal investigator, Rehabilitation Medicine, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089736
- Sponsor's protocol ID
- HNC, pain-coaching during RT
- Acronym
- HNC
- Status last verified
- Mar 2017
- First submitted
- 26 Aug 2015
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Related to Head and Neck Cancer (HNC); Implementation and Evaluation of Self-care Measure Due to the Same Illness During Radiotherapy (RT)
- ClinicalTrials.gov ID
- NCT03089736
- Acronym / sponsor ID
- HNC / HNC, pain-coaching during RT
- Conditions
- Pain, Head and Neck Cancer
- Keywords
- Pain, Head and neck cancer, depression, anxiety, health, catastrophizing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 19 Mar 2017 (actual)
- First posted
- 24 Mar 2017 (actual)
- 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.
The purpose of this study is to evaluate the effect of individual education and individual self-care measures on pain intensity, perceived health, mood and sleep during and after treatment with radiotherapy for head and neck cancer.
Detailed description
The purpose of this study is to evaluate the effect of individual education and individual self-care measures on pain intensity, perceived health, mood and sleep during and after treatment with radiotherapy for head and neck cancer
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAU + Education and self care | Experimental | Behavioral: Education, Behavioral: Self Care, Other: Treatment as usual (TAU)Treatment as usual (TAU; i.e. pharmacological treatments and advices) + structured education + instructions on self care |
| Treatment as usual (TAU) | Other | Other: Treatment as usual (TAU)Treatment as usual (TAU; i.e. pharmacological treatments and advices) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All HNC patients who went through RT and were referred to the Pain and Rehabilitation Centre at the University Hospital (Linköping, Sweden) were invited to participate in the study which run from January 2015 - March 2017.
- -
Key exclusion criteria (2 listed)
- Non Swedish speaking individuals, severe social and/or psychological disorders, severe cognitive conditions,other serious medical conditions.
- -
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 |
|---|---|---|
| EducationSix education areas was offered: pain and pain physiology, pain medication, side effects and prevention of side effects, abuse of medications, sleep advice and advice on anxiety. | Behavioural | TAU + Education and self care |
| Self CareThe following instructions on self-care for pain relief: apply ice or crushed ice in the oral cavity, lubricating and antiseptic mouth rinses, pain relieving gel, tongue movements and gaps exercises. Prevention of dryness in the mouth and throat; saliva stimulants and saliva substitute agents in different preparations, increased measures of good oral hygiene. Physical activities and regular rest once to several times per day. Sleep restriction and measures to treat sleep disorders. | Behavioural | TAU + Education and self care |
| Treatment as usual (TAU)pharmacological treatment + advices | Other | TAU + Education and self care, Treatment as usual (TAU) |
Primary outcome
Change in Pain intensity
Time frame: Change from baseline pain intensity at 20 weeks
Pain intensity the actual day using a numeric rating scale.
Change in Pain Interference
Time frame: Change from baseline pain interference at 20 weeks
Pain interference the actual day using a numeric rating scale
Change in Perceived health index
Time frame: Change from baseline EQ-5D index at 20 weeks
Perceived health according to the index based on five dimensions of European Quality of Life instrument (EQ-5D index)
Change in Perceived health scale
Time frame: Change from baseline EQ-VAS at 20 weeks
Perceived health according to the visual analgue scale of European Quality of Life instrument (EQ-VAS)
3 secondary outcomes
Change in depression
Time frame: Change from baseline depression at 20 weeks
Change in anxiety
Time frame: Change from baseline anxiety at 20 weeks
Change in catastrophizing
Time frame: Change from baseline catastrophizing at 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Bjorn Gerdle, Professor MD principal investigator
Rehabilitation Medicine, Linkoeping University
Questions about this trial
What is this clinical trial studying?
A study testing Education, Self Care and Treatment as usual (TAU) in people with Pain and Head and Neck Cancer, run by Linkoeping University.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Pain intensity (time frame: Change from baseline pain intensity at 20 weeks). The study lists 4 primary outcomes in all. 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 Mar 2017.