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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03089736
Acronym
HNC
Enrollment
62
Registered
2017-03-24
Start date
2015-01-01
Completion date
2017-03-19
Last updated
2017-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Pain

Keywords

Pain, Head and neck cancer, depression, anxiety, health, catastrophizing

Brief 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.

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

Interventions

BEHAVIORALEducation

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.

BEHAVIORALSelf 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.

OTHERTreatment as usual (TAU)

pharmacological treatment + advices

Sponsors

Linkoeping University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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. \-

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain intensityChange from baseline pain intensity at 20 weeksPain intensity the actual day using a numeric rating scale.
Change in Pain InterferenceChange from baseline pain interference at 20 weeksPain interference the actual day using a numeric rating scale
Change in Perceived health indexChange from baseline EQ-5D index at 20 weeksPerceived health according to the index based on five dimensions of European Quality of Life instrument (EQ-5D index)
Change in Perceived health scaleChange from baseline EQ-VAS at 20 weeksPerceived health according to the visual analgue scale of European Quality of Life instrument (EQ-VAS)

Secondary

MeasureTime frameDescription
Change in anxietyChange from baseline anxiety at 20 weeksAnxiety scale of Hospital and Depression Scale (HADS)
Change in catastrophizingChange from baseline catastrophizing at 20 weeksTotal score of Pain Catastrophizing scale
Change in depressionChange from baseline depression at 20 weeksDepression scale of Hospital and Depression Scale (HADS)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026