Occupational Therapy for Cancer Patients: a Randomised, Controlled Study
NCT ID: NCT01432197
Last Updated: 2011-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
116 participants
INTERVENTIONAL
2010-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Occupational therapy intervention
Intervention group: Standard treatment and care added with an ADL intervention program: 1) ADL training, 2) home modifications, 3) delivery and supervision in adaptive equipments, and 4) instruction in self-training programs.
Control group: Standard treatment and care. No occupational therapy intervention.
ADL intervention
1\) ADL training, 2) home modifications, 3) delivery and supervision in adaptive equipments, and 4) instruction in self-training programs.
Standard treatment and care
Control group: Standard treatment and care. No occupational therapy intervention.
No interventions assigned to this group
Interventions
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ADL intervention
1\) ADL training, 2) home modifications, 3) delivery and supervision in adaptive equipments, and 4) instruction in self-training programs.
Eligibility Criteria
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Inclusion Criteria
* Disability comparable with a performance status of 10 to 70 on Karnofsky Performance Status Scale
* Able to read and understand Danish
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Naestved Hospital
OTHER
University of Southern Denmark
OTHER
Responsible Party
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Line Lindahl
Ph.D student, OT, MPH
Principal Investigators
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Dorte Gilsaa Hansen, Ph.D, M.D.
Role: PRINCIPAL_INVESTIGATOR
Research Unit of General Practice, IST, University of Southern Denmark
Karen la Cour, Ph.D, OT, MSc
Role: PRINCIPAL_INVESTIGATOR
Health, Man and Society, IST, University of Southern Denmark
Locations
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Research Unit of General Practice, IST, University of Southern Denmark
Odense, , Denmark
Countries
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Other Identifiers
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RCT Occup Cancer
Identifier Type: -
Identifier Source: org_study_id
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