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

Pain Clinical Trial

— HNC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03089736
• Other study ID #: HNC, pain-coaching during RT
• Status: Completed
• Phase: N/A
• First received: August 26, 2015
• Last updated: March 29, 2017
• Start date: January 1, 2015
• Est. completion date: March 19, 2017

Study information

• Verified date: March 2017
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 19, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Pain

Intervention

Behavioral:
• 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.
• 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.

Other:
• Treatment as usual (TAU)
pharmacological treatment + advices

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain intensity	Pain intensity the actual day using a numeric rating scale.	Change from baseline pain intensity at 20 weeks
Primary	Change in Pain Interference	Pain interference the actual day using a numeric rating scale	Change from baseline pain interference at 20 weeks
Primary	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
Primary	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	Change in depression	Depression scale of Hospital and Depression Scale (HADS)	Change from baseline depression at 20 weeks
Secondary	Change in anxiety	Anxiety scale of Hospital and Depression Scale (HADS)	Change from baseline anxiety at 20 weeks
Secondary	Change in catastrophizing	Total score of Pain Catastrophizing scale	Change from baseline catastrophizing at 20 weeks