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

NCT ID: NCT03089736

Last Updated: 2017-03-30

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

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2017-03-19

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

Conditions

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Pain Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

All patients who referred to the Pain and Rehabilitation Centre at the University Hospital, asked about participation in the study. Of those who agreed to participate every second patient were distributed to the control group versus intervention group.

Study Groups

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TAU + Education and self care

Treatment as usual (TAU; i.e. pharmacological treatments and advices) + structured education + instructions on self care

Group Type EXPERIMENTAL

Education

Intervention Type 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

Intervention Type 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)

Intervention Type OTHER

pharmacological treatment + advices

Treatment as usual (TAU)

Treatment as usual (TAU; i.e. pharmacological treatments and advices)

Group Type OTHER

Treatment as usual (TAU)

Intervention Type OTHER

pharmacological treatment + advices

Interventions

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Education

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.

Intervention Type BEHAVIORAL

Self Care

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.

Intervention Type BEHAVIORAL

Treatment as usual (TAU)

pharmacological treatment + advices

Intervention Type OTHER

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.

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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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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Bjorn Gerdle

Professor MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bjorn Gerdle, Professor MD

Role: PRINCIPAL_INVESTIGATOR

Rehabilitation Medicine, Linkoeping University

Other Identifiers

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HNC, pain-coaching during RT

Identifier Type: -

Identifier Source: org_study_id

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