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NCT Number: NCT01432197

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.

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Key information

Conditions

HRQOL (Health Related Quality Of Life)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Research Unit of General Practice, IST, University of Southern Denmark

Odense, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADL intervention

Other
  • ADL training, 2) home modifications, 3) delivery and supervision in adaptive equipments, and 4) instruction in self-training programs.

Primary outcomes

  1. Health related quality of life

    Time frame: 15 months

Secondary outcomes

  1. Ability to perform activities of daily living

    Time frame: 15 months

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Naestved Hospital

Registry information

Official study title

Occupational Therapy for Cancer Patients: A Randomised Controlled Study

Important dates

Study start
2010
Primary completion
2011
First posted
Sep 12, 2011
Registry last updated
Sep 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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