title: Effectiveness of the "Cancer Home-Life Intervention" on everyday activities and quality of life in people with advanced cancer living at home: a randomised controlled trial and an economic evaluation.
abstract: BACKGROUND
  During the past decade an increasing number of people live with advanced cancer mainly due to improved medical treatment. Research has shown that many people with advanced cancer have problems with everyday activities, which have negative impact on their quality of life, and that they spend a considerable part of their time at home. Still, research on interventions to support the performance of and participation in everyday activities is only scarcely available. Therefore, the occupational therapy-based "Cancer Home-Life Intervention" consisting of tailored adaptive interventions applied in the participant's home environment was developed. The objective of this study is to examine the effectiveness and cost-effectiveness of the Cancer Home-Life Intervention compared to usual care on the performance of and participation in everyday activities and quality of life in people with advanced cancer living at home.
  
  
  METHODS
  The study is a randomised, controlled trial (RCT) including an economic evaluation. The required sample size of 272 adults living at home will be recruited from outpatient clinics at two Danish hospitals. They should be diagnosed with cancer; evaluated incurable by the responsible oncologist; and with a functional level 1-2 on the WHO performance scale. The primary outcome is the quality of performance of activities of daily living. Secondary outcomes are problems with prioritised everyday activities; autonomy and participation; and health-related quality of life. Participants are randomly assigned to: a) The Cancer Home-Life Intervention in addition to usual care, and b) Usual care alone.
  
  
  CONCLUSIONS
  The trial will show whether the Cancer Home-Life Intervention provides better support for people with advanced cancer living at home in performing and participating in everyday activities, and whether it contributes to their health-related quality of life. The economic evaluation alongside the RCT will show if the Cancer Home-Life Intervention is cost-effective. The trial will also show the acceptability of the intervention to the target group, and whether subgroups of participants will benefit more than others.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier NCT02356627. Registered 02/02/2015.
authors.affiliation: The National Board of Social Services, 5000, Odense C, Denmark. aabrandt@health.sdu.dk.|The Research Initiative of Activity Studies and Occupational Therapy, Research Unit of General Practice, Department of Public Health, University of Southern Denmark, 5000, Odense C, Denmark. aabrandt@health.sdu.dk.|OPEN Odense Patient data Explorative Network, Odense University Hospital and University of Southern Denmark, 5000, Odense C, Denmark. aabrandt@health.sdu.dk.
authors.forename: Å
authors.initials: Å
authors.lastname: Brandt
authors.affiliation: The Research Initiative of Activity Studies and Occupational Therapy, Research Unit of General Practice, Department of Public Health, University of Southern Denmark, 5000, Odense C, Denmark.|OPEN Odense Patient data Explorative Network, Odense University Hospital and University of Southern Denmark, 5000, Odense C, Denmark.
authors.forename: M S
authors.initials: MS
authors.lastname: Pilegaard
authors.affiliation: The Research Initiative of Activity Studies and Occupational Therapy, Research Unit of General Practice, Department of Public Health, University of Southern Denmark, 5000, Odense C, Denmark.|OPEN Odense Patient data Explorative Network, Odense University Hospital and University of Southern Denmark, 5000, Odense C, Denmark.|Department of Physiotherapy and Occupational Therapy, Aarhus University Hospital, 8000, Aarhus C, Denmark.|Institute of Public Health, Aarhus University, 8000, Aarhus C, Denmark.
authors.forename: L G
authors.initials: LG
authors.lastname: Oestergaard
authors.affiliation: The Research Initiative of Activity Studies and Occupational Therapy, Research Unit of General Practice, Department of Public Health, University of Southern Denmark, 5000, Odense C, Denmark.|OPEN Odense Patient data Explorative Network, Odense University Hospital and University of Southern Denmark, 5000, Odense C, Denmark.
authors.forename: L
authors.initials: L
authors.lastname: Lindahl-Jacobsen
authors.affiliation: Centre of Health Economics Research (COHERE), Department of Public Health, University of Southern Denmark, 5000, Odense C, Denmark.
authors.forename: J
authors.initials: J
authors.lastname: Sørensen
authors.affiliation: Department of Psychology, University of Southern Denmark, 5230, Odense M, Denmark.|Department of Palliative Medicine, Bispebjerg Hospital, 2400, Copenhagen, NV, Denmark.
authors.forename: A T
authors.initials: AT
authors.lastname: Johnsen
authors.affiliation: The Research Initiative of Activity Studies and Occupational Therapy, Research Unit of General Practice, Department of Public Health, University of Southern Denmark, 5000, Odense C, Denmark.|OPEN Odense Patient data Explorative Network, Odense University Hospital and University of Southern Denmark, 5000, Odense C, Denmark.
authors.forename: K
authors.initials: K
authors.lastname: la Cour
mesh_terms: D000203:Activities of Daily Living / Q000523:psychology; D000328:Adult; D003362:Cost-Benefit Analysis; D005260:Female; D006699:Home Care Services / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000191:economics* / Q000523:psychology*; D015397:Program Evaluation; D011788:Quality of Life / Q000523:psychology*