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CompletedNCT03089736HNCUpdated Mar 30, 2017

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

An interventional study of Education and Self Care in Pain and Head and Neck Cancer, sponsored by Linkoeping University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-30.

Sponsored by Linkoeping University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jan 2015, registered Aug 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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

02

Conditions studied

  • Pain
  • Head and Neck Cancer

Keywords

  • Pain
  • Head and neck cancer
  • depression
  • anxiety
  • health
  • catastrophizing
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 552 are open to participants now.

This study's enrollment of 62 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Linkoeping University is the lead sponsor of 189 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

-

Exclusion Criteria:

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

-

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    TAU + Education and self care

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

    Behavioral: Education · Behavioral: Self Care · Other: Treatment as usual (TAU)

  • Other
    Treatment as usual (TAU)

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

    Other: Treatment as usual (TAU)

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

06

What researchers measure

Primary outcomes

  1. Change in Pain intensity

    Pain intensity the actual day using a numeric rating scale.

    Time frame: Change from baseline pain intensity at 20 weeks

  2. Change in Pain Interference

    Pain interference the actual day using a numeric rating scale

    Time frame: Change from baseline pain interference at 20 weeks

  3. Change in Perceived health index

    Perceived health according to the index based on five dimensions of European Quality of Life instrument (EQ-5D index)

    Time frame: Change from baseline EQ-5D index at 20 weeks

  4. Change in Perceived health scale

    Perceived health according to the visual analgue scale of European Quality of Life instrument (EQ-VAS)

    Time frame: Change from baseline EQ-VAS at 20 weeks

Secondary outcomes

  1. Change in depression

    Depression scale of Hospital and Depression Scale (HADS)

    Time frame: Change from baseline depression at 20 weeks

  2. Change in anxiety

    Anxiety scale of Hospital and Depression Scale (HADS)

    Time frame: Change from baseline anxiety at 20 weeks

  3. Change in catastrophizing

    Total score of Pain Catastrophizing scale

    Time frame: Change from baseline catastrophizing at 20 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03089736
Lead sponsor
Linkoeping University
Responsible party
Bjorn Gerdle (Professor MD, Linkoeping University) — Principal investigator
First posted
Mar 24, 2017
Start date
Jan 1, 2015
Primary completion
Dec 31, 2016
Completion
Mar 19, 2017
Last update
Mar 30, 2017

Study contacts

Bjorn Gerdle, Professor MD
principal investigator · Rehabilitation Medicine, Linkoeping University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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