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Completed

NCT Number: NCT03089736

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

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.

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Key information

Conditions

Pain Anxiety Disorders Behavior Behavioral Symptoms Depression Head and Neck Cancer Head and Neck Neoplasms Mental Disorders Neoplasms Neoplasms by Site Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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Exclusion criteria

Non Swedish speaking individuals, severe social and/or psychological disorders, severe cognitive conditions,other serious medical conditions.

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Treatment and study plan

Education

Behavioral

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 Care

Behavioral

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.

Treatment as usual (TAU)

Other

pharmacological treatment + advices

Primary outcomes

  1. Change in Pain intensity

    Time frame: Change from baseline pain intensity at 20 weeks

    Pain intensity the actual day using a numeric rating scale.

  2. Change in Pain Interference

    Time frame: Change from baseline pain interference at 20 weeks

    Pain interference the actual day using a numeric rating scale

  3. 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)

  4. 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)

Secondary outcomes

  1. Change in depression

    Time frame: Change from baseline depression at 20 weeks

    Depression scale of Hospital and Depression Scale (HADS)

  2. Change in anxiety

    Time frame: Change from baseline anxiety at 20 weeks

    Anxiety scale of Hospital and Depression Scale (HADS)

  3. Change in catastrophizing

    Time frame: Change from baseline catastrophizing at 20 weeks

    Total score of Pain Catastrophizing scale

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

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

Acronym: HNC

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Mar 24, 2017
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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