Occupational Therapy for Cancer Patients: a Randomised, Controlled Study
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 8, 2011 | ||||||||
| Last Updated Date | September 9, 2011 | ||||||||
| Start Date ICMJE | March 2010 | ||||||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Health related quality of life [ Time Frame: 15 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01432197 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Ability to perform activities of daily living [ Time Frame: 15 months ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Occupational Therapy for Cancer Patients: a Randomised, Controlled Study | ||||||||
| Official Title ICMJE | Occupational Therapy for Cancer Patients: A Randomised Controlled Study | ||||||||
| Brief Summary | 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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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 0 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | HRQOL (Health Related Quality of Life) | ||||||||
| Intervention ICMJE | Other: ADL intervention
1) ADL training, 2) home modifications, 3) delivery and supervision in adaptive equipments, and 4) instruction in self-training programs. |
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| Study Arm (s) |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 116 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Denmark | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01432197 | ||||||||
| Other Study ID Numbers ICMJE | RCT Occup Cancer | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Line Lindahl, University of Southern Denmark | ||||||||
| Study Sponsor ICMJE | University of Southern Denmark | ||||||||
| Collaborators ICMJE | Naestved Hospital | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Southern Denmark | ||||||||
| Verification Date | September 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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