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Clinical Trials/NCT01432197
NCT01432197
Completed
Early Phase 1

Occupational Therapy for Cancer Patients: A Randomised Controlled Study

University of Southern Denmark1 site in 1 country116 target enrollmentMarch 2010

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
HRQOL (Health Related Quality of Life)
Sponsor
University of Southern Denmark
Enrollment
116
Locations
1
Primary Endpoint
Health related quality of life
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

The aim of this study is to investigate the effect of occupational therapy, in shape of activities of daily living, for cancer patients.

Detailed Description

Background Cancer patients often experience serious dysfunctions leading to problems with activities of daily living (ADL) and reduced quality of life. Occupational therapy is believed to be effective in handling many of the problems with ADL experienced by patients with cancer, but the evidence is sparse. Aim The purpose of this study is to analyse the effects of an occupational therapy intervention targeting cancer patients. Outcome measures are the patients self-reported quality of life and the patients ability to perform ADL. Methods Randomised controlled trial with 288 patients with cancer treated at Naestved hospital in Denmark. Occupational therapy intervention programme for the intervention group (N=144) and standard treatment and care for the controls (N=144). A systematic review including studies of ADL intervention for cancer patients will be carried out. Feasibility of the recruitment and the intervention will be analysed and published. The patients need for occupational therapy will be analysed using baseline information from the randomised controlled trial. The effects of the intervention will be analysed using patient validated questionnaires including EORTC QLQ-C30 and the ADL taxonomy questionnaire.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
June 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Line Lindahl

Ph.D student, OT, MPH

University of Southern Denmark

Eligibility Criteria

Inclusion Criteria

  • Cancer patients
  • Disability comparable with a performance status of 10 to 70 on Karnofsky Performance Status Scale
  • Able to read and understand Danish

Exclusion Criteria

  • Referred to occupational therapy before study start

Outcomes

Primary Outcomes

Health related quality of life

Time Frame: 15 months

Secondary Outcomes

  • Ability to perform activities of daily living(15 months)

Study Sites (1)

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