Occupational Therapy for Cancer Patients: a Randomised, Controlled Study

Early Phase 1

Completed

• Conditions: HRQOL (Health Related Quality of Life)
• Interventions: Other: ADL intervention

• Registration Number: NCT01432197
• Lead Sponsor: University of Southern Denmark

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.

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2011-06
• Status Verified: 2011-09
• Study First Submitted: 2011-09-08
• Study First Submitted QC: 2011-09-09
• Last Update Submitted: 2011-09-09
• Study First Posted: 2011-09-12
• Last Update Posted: 2011-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Occupational therapy intervention	ADL 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.

Primary Outcome Measures

Name	Time	Method
Health related quality of life	15 months

Secondary Outcome Measures

Name	Time	Method
Ability to perform activities of daily living	15 months

Trial Locations

Locations (1)

Research Unit of General Practice, IST, University of Southern Denmark; 🇩🇰 Odense, Denmark