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

NCT03089736 | Completed

• 1 other identifier: HNC, pain-coaching during RT
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain; Head and Neck Cancer

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Change in Pain intensity

  Pain intensity the actual day using a numeric rating scale.

  Change from baseline pain intensity at 20 weeks

• Change in Pain Interference

  Pain interference the actual day using a numeric rating scale

  Change from baseline pain interference at 20 weeks

• 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

• 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 Outcomes (3)

• Change in depression

  Change from baseline depression at 20 weeks

• Change in anxiety

  Change from baseline anxiety at 20 weeks

• Change in catastrophizing

  Change from baseline catastrophizing at 20 weeks

Study Arms (2)

TAU + Education and self care

EXPERIMENTAL

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)

Treatment as usual (TAU)

OTHER

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

Other: Treatment as usual (TAU)

Interventions

Education BEHAVIORAL

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.

TAU + Education and self care

Self Care BEHAVIORAL

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.

TAU + Education and self care

Treatment as usual (TAU) OTHER

pharmacological treatment + advices

TAU + Education and self care; Treatment as usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Linkoeping University: lead

MeSH Terms

Conditions

Pain; Head and Neck Neoplasms; Depression; Anxiety Disorders

Interventions

Educational Status; Self Care; Therapeutics

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Bjorn Gerdle, Professor MD

  Rehabilitation Medicine, Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor MD

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: March 24, 2017
• Study Start: January 1, 2015
• Primary Completion: December 31, 2016
• Study Completion: March 19, 2017
• Last Updated: March 30, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share