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Occupational Therapy for Cancer Patients: A Randomised Controlled Study


Phase 0
18 Years
N/A
Not Enrolling
Both
HRQOL (Health Related Quality of Life)

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Trial Information

Occupational Therapy for Cancer Patients: A Randomised Controlled 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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Health related quality of life

Outcome Time Frame:

15 months

Safety Issue:

No

Principal Investigator

Dorte Gilsaa Hansen, Ph.D, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Denmark: The Danish Data Protection Agency

Study ID:

RCT Occup Cancer

NCT ID:

NCT01432197

Start Date:

March 2010

Completion Date:

Related Keywords:

  • HRQOL (Health Related Quality Of Life)
  • HRQOL
  • Occupational therapy
  • ADL intervention
  • Cancer patients

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