Occupational Therapy for Cancer Patients: a Randomised, Controlled Study

HRQOL (Health Related Quality of Life) Clinical Trial

Official title:

Occupational Therapy for Cancer Patients: A Randomised Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01432197
• Other study ID #: RCT Occup Cancer
• Status: Completed
• Phase: Phase 0
• First received: September 8, 2011
• Last updated: September 9, 2011
• Start date: March 2010

Study information

• Verified date: September 2011
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish Data Protection Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• HRQOL (Health Related Quality of Life)

Intervention

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

Locations

Country	Name	City	State
Denmark	Research Unit of General Practice, IST, University of Southern Denmark	Odense

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	Naestved Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related quality of life		15 months	No
Secondary	Ability to perform activities of daily living		15 months	No