Back to resultsPain Related to Head and Neck Cancer (HNC); Implementation and Evaluation of Self-care Measure Due to the Same Illness (HNC)
Primary Purpose
Pain, Head and Neck Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Education
Self Care
Treatment as usual (TAU)
Sponsored by
About this trial
This is an interventional supportive care trial for Pain focused on measuring Pain, Head and neck cancer, depression, anxiety, health, catastrophizing
Eligibility Criteria
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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Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
TAU + Education and self care
Treatment as usual (TAU)
Arm Description
Treatment as usual (TAU; i.e. pharmacological treatments and advices) + structured education + instructions on self care
Treatment as usual (TAU; i.e. pharmacological treatments and advices)
Outcomes
Primary Outcome Measures
Change in Pain intensity
Pain intensity the actual day using a numeric rating scale.
Change in Pain Interference
Pain interference the actual day using a numeric rating scale
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 in Perceived health scale
Perceived health according to the visual analgue scale of European Quality of Life instrument (EQ-VAS)
Secondary Outcome Measures
Change in depression
Depression scale of Hospital and Depression Scale (HADS)
Change in anxiety
Anxiety scale of Hospital and Depression Scale (HADS)
Change in catastrophizing
Total score of Pain Catastrophizing scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03089736
Brief Title
Pain Related to Head and Neck Cancer (HNC); Implementation and Evaluation of Self-care Measure Due to the Same Illness
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
March 19, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Head and Neck Cancer
Keywords
Pain, Head and neck cancer, depression, anxiety, health, catastrophizing
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
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.
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAU + Education and self care
Arm Type
Experimental
Arm Description
Treatment as usual (TAU; i.e. pharmacological treatments and advices) + structured education + instructions on self care
Arm Title
Treatment as usual (TAU)
Arm Type
Other
Arm Description
Treatment as usual (TAU; i.e. pharmacological treatments and advices)
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
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
Intervention Name(s)
Self Care
Intervention Description
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
Other
Intervention Name(s)
Treatment as usual (TAU)
Intervention Description
pharmacological treatment + advices
Primary Outcome Measure Information:
Title
Change in Pain intensity
Description
Pain intensity the actual day using a numeric rating scale.
Time Frame
Change from baseline pain intensity at 20 weeks
Title
Change in Pain Interference
Description
Pain interference the actual day using a numeric rating scale
Time Frame
Change from baseline pain interference at 20 weeks
Title
Change in Perceived health index
Description
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
Title
Change in Perceived health scale
Description
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 Outcome Measure Information:
Title
Change in depression
Description
Depression scale of Hospital and Depression Scale (HADS)
Time Frame
Change from baseline depression at 20 weeks
Title
Change in anxiety
Description
Anxiety scale of Hospital and Depression Scale (HADS)
Time Frame
Change from baseline anxiety at 20 weeks
Title
Change in catastrophizing
Description
Total score of Pain Catastrophizing scale
Time Frame
Change from baseline catastrophizing at 20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bjorn Gerdle, Professor MD
Organizational Affiliation
Rehabilitation Medicine, Linkoeping University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pain Related to Head and Neck Cancer (HNC); Implementation and Evaluation of Self-care Measure Due to the Same Illness
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