Skip to content

Efficacy of a guided self-help exercise program targeting speech, swallowing and shoulder problems in laryngectomized patients: a randomized controlled trial

Efficacy of a guided self-help exercise program targeting speech, swallowing and shoulder problems in laryngectomized patients: a randomized controlled trial - Efficacy of a guided self-help exercise program in laryngectomized patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43884
Enrollment
100
Registered
2015-01-21
Start date
2015-06-21
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

head and neck cancer laryngeal cancer

Interventions

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

Sponsors

KNO/hoofd-halschirurgie
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients treated with total laryngectomy in the last 5 years

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)