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Efficacy of a guided self-help exercise program in laryngectomized patients


- candidate number22351
- NTR NumberNTR5255
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-jun-2015
- Secondary IDsMETC VUmc 2014.514 
- Public TitleEfficacy of a guided self-help exercise program in laryngectomized patients
- Scientific TitleEfficacy of a guided self-help exercise program targeting speech, swallowing and shoulder problems in laryngectomized patients: a randomized controlled trial
- ACRONYM
- hypothesisTreatment of patients diagnosed with laryngeal cancer with total laryngectomy with or without (chemo)radiation often induces speech, swallowing and shoulder complaints. Speech, swallowing and shoulder exercises may prevent or diminish these complaints. The aim of this study is to investigate the efficacy and cost-effectiveness of the guided self-help exercise program build into the application “in Tune without Cords” to prevent or reduce speech, swallowing and neck and shoulder problems in patients treated with total laryngectomy.
- Healt Condition(s) or Problem(s) studiedLaryngopharynx
- Inclusion criteriaIn order to be eligible to participate in this study, a patient must meet all of the following criteria:
1) treated with total laryngectomy with or without (chemo)radiation up to five years ago in one of the participating head and neck cancer centers; and
2) provided written informed consent.
- Exclusion criteriaA potential participant who meets any of the following criteria will be excluded from participation in this study:
1) treated with total laryngectomy combined with a total glossectomy;
2)treated with partial laryngectomy;
3) younger than 18 years;
4) having cognitive impairments; and/or
5) unable to understand the Dutch language.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2015
- planned closingdate1-jul-2016
- Target number of participants100
- InterventionsThe intervention investigated in this study is a guided self-help exercise program targeting speech, swallowing and shoulder problems called “In Tune without Cords”. This guided self-help exercise program is provided by Internet or booklet plus DVD.
- Primary outcomeThe primary outcome measure of this study is the swallowing quality of life questionnaire (SWAL-QoL).
- Secondary outcomeSecondary outcome measures of this study are the speech handicap index (SHI), the shoulder disability questionnaire (SDQ), the EORTC generic and head and neck cancer specific quality of life questionnaires (EORTC-QLQC30 and H&N35), the EuroQol-5 dimensions (EQ-5d), cost questionnaires and the Patient Activation Measure (PAM).
- TimepointsPatient reported outcome measures will be assessed at baseline, after the intervention or control period and three months after the intervention or control period.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. I.M. Verdonck-de Leeuw
- CONTACT for SCIENTIFIC QUERIESDr. I.M. Verdonck-de Leeuw
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Michiel Keijzer Fund
- Publications
- Brief summaryTreatment of patients diagnosed with laryngeal cancer with total laryngectomy with or without (chemo)radiation often induces speech, swallowing and shoulder complaints. Speech, swallowing and shoulder exercises may prevent or diminish these complaints. The aim of this study is to investigate the efficacy and cost-effectiveness of the guided self-help exercise program build into the application “in Tune without Cords” to prevent or reduce speech, swallowing and neck and shoulder problems in patients treated with total laryngectomy.
- Main changes (audit trail)
- RECORD17-jun-2015 - 17-okt-2015


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