Pain Related to Head and Neck Cancer (HNC); Implementation and Evaluation of Self-care Measure Due to the Same Illness

Study Overview
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Brief Summary
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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
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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

Official Title
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Pain Related to Head and Neck Cancer (HNC); Implementation and Evaluation of Self-care Measure Due to the Same Illness During Radiotherapy (RT)

Conditions
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Pain, Head and Neck Cancer

Intervention / Treatment
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* Behavioral: Education
* Behavioral: Self Care
* Other: Treatment as usual (TAU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. - Exclusion Criteria: Non Swedish speaking individuals, severe social and/or psychological disorders, severe cognitive conditions,other serious medical conditions. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAU + Education and self care<br>Treatment as usual (TAU; i.e. pharmacological treatments and advices) + structured education + instructions on self care | Behavioral: Education<br>* 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.<br>Behavioral: Self Care<br>* 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.<br>Other: Treatment as usual (TAU)<br>* pharmacological treatment + advices<br>|
| Other: Treatment as usual (TAU)<br>Treatment as usual (TAU; i.e. pharmacological treatments and advices) | Other: Treatment as usual (TAU)<br>* pharmacological treatment + advices<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain intensity | Pain intensity the actual day using a numeric rating scale. | Change from baseline pain intensity at 20 weeks | 
| Change in Pain Interference | Pain interference the actual day using a numeric rating scale | 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) | 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) | Change from baseline EQ-VAS at 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression | Depression scale of Hospital and Depression Scale (HADS) | Change from baseline depression at 20 weeks | 
| Change in anxiety | Anxiety scale of Hospital and Depression Scale (HADS) | Change from baseline anxiety at 20 weeks | 
| Change in catastrophizing | Total score of Pain Catastrophizing scale | Change from baseline catastrophizing at 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Head and neck cancer, depression, anxiety, health, catastrophizing