Occupational Therapy for Cancer Patients: a Randomised, Controlled Study

This study has been completed.
Sponsor:
Collaborator:
Naestved Hospital
Information provided by (Responsible Party):
Line Lindahl, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01432197
First received: September 8, 2011
Last updated: September 9, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
HRQOL (Health Related Quality of Life)
Other: ADL intervention
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Occupational Therapy for Cancer Patients: A Randomised Controlled Study

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Health related quality of life [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ability to perform activities of daily living [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Enrollment: 116
Study Start Date: March 2010
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Occupational therapy 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.

Other: ADL intervention
1) ADL training, 2) home modifications, 3) delivery and supervision in adaptive equipments, and 4) instruction in self-training programs.
No Intervention: Standard treatment and care
Control group: Standard treatment and care. No occupational therapy intervention.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432197

Locations
Denmark
Research Unit of General Practice, IST, University of Southern Denmark
Odense, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Naestved Hospital
Investigators
Principal Investigator: Dorte Gilsaa Hansen, Ph.D, M.D. Research Unit of General Practice, IST, University of Southern Denmark
Principal Investigator: Karen la Cour, Ph.D, OT, MSc Health, Man and Society, IST, University of Southern Denmark
  More Information

No publications provided

Responsible Party: Line Lindahl, Ph.D student, OT, MPH, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01432197     History of Changes
Other Study ID Numbers: RCT Occup Cancer
Study First Received: September 8, 2011
Last Updated: September 9, 2011
Health Authority: Denmark: The Danish Data Protection Agency

Keywords provided by University of Southern Denmark:
HRQOL
Occupational therapy
ADL intervention
Cancer patients

ClinicalTrials.gov processed this record on October 19, 2014