To investigate the efficacy of the guided self-help exercise program of *in Tune without Cords* among laryngectomized patients.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measures are differences in swallowing quality (swallowing
quality of life questionnaire), speech problems (speech handicap index) and
shoulder disability (shoulder disability questionnaire) between the
intervention and control group at follow-up measurements.
Secondary outcome
Secondary outcome measures are generic and head and neck cancer specific
quality of life (EORTC quality of life core module and head and neck cancer
module), the incremental cost effectiveness ratio (calculated using different
cost questionnaires and the EuroQol-5 dimensions) and self-management (patients
activation measure).
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.
Study objective
To investigate the efficacy of the guided self-help exercise program of *in
Tune without Cords* among laryngectomized patients.
Study design
A prospective randomized controlled trial with two parallel groups (1:1)
comparing a guided self-help exercise program targeting speech, swallowing and
neck and shoulder problems to a control group with measures 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 provided by Internet or booklet plus DVD targeting speech, swallowing
and shoulder problems. Patients are asked to exercise themselves at home using
the Internet or booklet plus DVD containing written instructions, images and
videos of prescribed exercises. Patients are asked to exercise three times a
day (10-15 minutes a time) for 12 weeks.
Study burden and risks
Risks are negligible and burden is low. In case of positive results,
participating patients will probably benefit immediately from the guided
self-help exercise program.
de Boelelaan 1117 de Boelelaan 1117
Amsterdam 1081 HV
NL
de Boelelaan 1117 de Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Patients treated with total laryngectomy in the last 5 years
Exclusion criteria
Patients treated with total laryngectomy combined with a total glossectomy, patients treated with a partial laryngectomy, patients younger than 18 years, patients with cognitive impairments or who do not 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 |
|---|---|
| CCMO | NL51261.029.14 |