Occupational Therapy for Cancer Patients: a Randomised, Controlled Study

September 9, 2011 updated by: Line Lindahl, University of Southern Denmark

Occupational Therapy for Cancer Patients: A Randomised Controlled Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Research Unit of General Practice, IST, University of Southern Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: ADL intervention
1) ADL training, 2) home modifications, 3) delivery and supervision in adaptive equipments, and 4) instruction in self-training programs.
No Intervention: Standard treatment and care
Control group: Standard treatment and care. No occupational therapy intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Health related quality of life
Time Frame: 15 months
15 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Ability to perform activities of daily living
Time Frame: 15 months
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Naestved Hospital

Investigators

  • Principal Investigator: Dorte Gilsaa Hansen, Ph.D, M.D., Research Unit of General Practice, IST, University of Southern Denmark
  • Principal Investigator: Karen la Cour, Ph.D, OT, MSc, Health, Man and Society, IST, University of Southern Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

September 8, 2011

First Submitted That Met QC Criteria

September 9, 2011

First Posted (Estimate)

September 12, 2011

Study Record Updates

Last Update Posted (Estimate)

September 12, 2011

Last Update Submitted That Met QC Criteria

September 9, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RCT Occup Cancer

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HRQOL (Health Related Quality of Life)

Clinical Trials on ADL intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe