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Effectiveness and cost-utility of a guided self-help exercise program for patients treated with total laryngectomy: protocol of a multi-center randomized controlled trial.
- Source :
- BMC Cancer; 8/2/2016, Vol. 16, p1-10, 10p, 2 Color Photographs, 1 Diagram
- Publication Year :
- 2016
-
Abstract
- <bold>Background: </bold>Total laryngectomy with or without adjuvant (chemo)radiation often induces speech, swallowing and neck and shoulder problems. Speech, swallowing and shoulder exercises may prevent or diminish these problems. The aim of the present paper is to describe the study, which is designed to investigate the effectiveness and cost-utility of a guided self-help exercise program built into the application "In Tune without Cords" among patients treated with total laryngectomy.<bold>Methods/design: </bold>Patients, up to 5 years earlier treated with total laryngectomy with or without (chemo)radiation will be recruited for participation in this study. Patients willing to participate will be randomized to the intervention or control group (1:1). Patients in the intervention group will be provided access to a guided self-help exercise program and a self-care education program built into the application "In Tune without Cords". Patients in the control group will only be provided access to the self-care education program. The primary outcome is the difference in swallowing quality (SWAL-QOL) between the intervention and control group. Secondary outcome measures address speech problems (SHI), shoulder disability (SDQ), quality of life (EORTC QLQ-C30, QLQ-H&N35 and EQ-5D), direct and indirect costs (adjusted iMCQ and iPCQ measures) and self-management (PAM). Patients will be asked to complete these outcome measures at baseline, immediately after the intervention or control period (i.e. at 3 months follow-up) and at 6 months follow-up.<bold>Discussion: </bold>This randomized controlled trial will provide knowledge on the effectiveness of a guided self-help exercise program for patients treated with total laryngectomy. In addition, information on the value for money of such an exercise program will be provided. If this guided self-help program is (cost)effective for patients treated with total laryngectomy, the next step will be to implement this exercise program in current clinical practice.<bold>Trial Registration: </bold>NTR5255 Protocol version 4 date September 2015. [ABSTRACT FROM AUTHOR]
- Subjects :
- LARYNGECTOMY
PHYSICAL training & conditioning
SHOULDER exercises
LARYNGECTOMEES
RANDOMIZED controlled trials
EXERCISE therapy
COMPARATIVE studies
COST effectiveness
DEGLUTITION disorders
EXPERIMENTAL design
LONGITUDINAL method
RESEARCH methodology
MEDICAL cooperation
PATIENT education
QUALITY of life
QUESTIONNAIRES
RESEARCH
HEALTH self-care
SPEECH disorders
EVALUATION research
TREATMENT effectiveness
ECONOMICS
Subjects
Details
- Language :
- English
- ISSN :
- 14712407
- Volume :
- 16
- Database :
- Complementary Index
- Journal :
- BMC Cancer
- Publication Type :
- Academic Journal
- Accession number :
- 117200497
- Full Text :
- https://doi.org/10.1186/s12885-016-2613-6