Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 8, 2011
September 9, 2011
March 2010
June 2011   (final data collection date for primary outcome measure)
Health related quality of life [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01432197 on ClinicalTrials.gov Archive Site
Ability to perform activities of daily living [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Occupational Therapy for Cancer Patients: a Randomised, Controlled Study
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.

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.

Interventional
Phase 0
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
HRQOL (Health Related Quality of Life)
Other: ADL intervention
1) ADL training, 2) home modifications, 3) delivery and supervision in adaptive equipments, and 4) instruction in self-training programs.
  • 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.

    Intervention: Other: ADL intervention
  • No Intervention: Standard treatment and care
    Control group: Standard treatment and care. No occupational therapy intervention.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
Not Provided
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01432197
RCT Occup Cancer
No
Line Lindahl, University of Southern Denmark
University of Southern Denmark
Naestved Hospital
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
University of Southern Denmark
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP