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Self-management Support in Cancer Pain

Maastricht University Medical Centre (MUMC) logo

Maastricht University Medical Centre (MUMC)

Status

Unknown

Conditions

Pain

Treatments

Behavioral: Self-management support

Study type

Interventional

Funder types

Other

Identifiers

NCT02333968
UM 2011-5079

Details and patient eligibility

About

Pain is a prevalent and distressing symptom in patients with cancer, having an enormous impact on functioning and quality of life. Integration of patient self-management and professional care by means of care technology provides new opportunities in the outpatient setting. In this project a technology based and nurse delivered multicomponent self-management support intervention has been developed. Important components include monitoring, feedback, education, and nurse support. Following feasibility evaluation, the primary aim of this randomized controlled trial is to assess the effect of the intervention regarding pain intensity and quality of life as compared to care as usual. Secondary outcomes of the effect evaluation are self-efficacy, knowledge, anxiety and depression, and pain medication use. Besides, a cost-evaluation and summative process evaluation will be performed.

Enrollment

174 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of cancer
  • Patients who are under (palliative) anti-tumour treatment in a day clinic or outpatient clinic, or patients who have no treatment options available anymore
  • Cancer (treatment related) pain > 2 weeks
  • Pain is defined as a patient reported pain score of 4 or more on a numerical rating scale (scale 0-10)
  • Living at home

Exclusion criteria

  • Expected life expectancy < 3 months
  • Chronic non-cancer pain
  • Known cognitive impairments
  • Participation in other studies that interfere with this study
  • Not being able to read and understand the Dutch language
  • Reduced vision
  • Non-reachable by phone

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

174 participants in 2 patient groups

Intervention group
Experimental group
Description:
Self-management support
Treatment:
Behavioral: Self-management support
Control group
No Intervention group
Description:
Care as usual

Trial contacts and locations

2

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Central trial contact

Laura Hochstenbach, MSc

Data sourced from clinicaltrials.gov

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