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

Not Applicable

Completed

• Conditions: Pain; Head and Neck Cancer
• Interventions: Behavioral: Education; Behavioral: Self Care; Other: Treatment as usual (TAU)

• Registration Number: NCT03089736
• Lead Sponsor: Linkoeping University

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

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2015-08-26
• Primary Completion: 2016-12-31
• Status Verified: 2017-03
• Study Completion: 2017-03-19
• Study First Submitted QC: 2017-03-19
• Study First Posted: 2017-03-24
• Last Update Submitted: 2017-03-29
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAU + Education and self care	Education	Treatment as usual (TAU; i.e. pharmacological treatments and advices) + structured education + instructions on self care
TAU + Education and self care	Self Care	Treatment as usual (TAU; i.e. pharmacological treatments and advices) + structured education + instructions on self care
TAU + Education and self care	Treatment as usual (TAU)	Treatment as usual (TAU; i.e. pharmacological treatments and advices) + structured education + instructions on self care
Treatment as usual (TAU)	Treatment as usual (TAU)	Treatment as usual (TAU; i.e. pharmacological treatments and advices)

Primary Outcome Measures

Name	Time	Method
Change in Pain intensity	Change from baseline pain intensity at 20 weeks	Pain intensity the actual day using a numeric rating scale.
Change in Pain Interference	Change from baseline pain interference at 20 weeks	Pain interference the actual day using a numeric rating scale
Change in Perceived health index	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)
Change in Perceived health scale	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 Outcome Measures

Name	Time	Method
Change in depression	Change from baseline depression at 20 weeks	Depression scale of Hospital and Depression Scale (HADS)
Change in anxiety	Change from baseline anxiety at 20 weeks	Anxiety scale of Hospital and Depression Scale (HADS)
Change in catastrophizing	Change from baseline catastrophizing at 20 weeks	Total score of Pain Catastrophizing scale