Occupational Therapy for Cancer Patients: a Randomised, Controlled Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Occupational Therapy for Cancer Patients: A Randomised Controlled Study

Conditions
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HRQOL (Health Related Quality of Life)

Intervention / Treatment
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* Other: ADL intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life |  | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to perform activities of daily living |  | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HRQOL, Occupational therapy, ADL intervention, Cancer patients