No registrations found.
ID
Source
Health condition
Patients treated with total laryngectomy, laryngeal cancer, speech problems, swallowing problems, shoulder problems
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure of this study is the swallowing quality of life questionnaire (SWAL-QoL).
Secondary outcome
Secondary 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).
Background summary
Treatment 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.
Study objective
Treatment 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.
Study design
Patient reported outcome measures will be assessed at baseline, after the intervention or control period and three months after the intervention or control period.
Intervention
The 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.
I.M. Verdonck-de Leeuw
VU University Medical Center (VUmc)
Dept of Otolaryngology-Head & Neck Surgery
Amsterdam 1007 MB
The Netherlands
+31(0)20-4443690
im.verdonck@vumc.nl
I.M. Verdonck-de Leeuw
VU University Medical Center (VUmc)
Dept of Otolaryngology-Head & Neck Surgery
Amsterdam 1007 MB
The Netherlands
+31(0)20-4443690
im.verdonck@vumc.nl
Inclusion criteria
In 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 criteria
A 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5123 |
| NTR-old | NTR5255 |
| Other | : METC VUmc 2014.514 |