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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21069
Enrollment
100
Registered
2015-06-17
Start date
2015-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Patients treated with total laryngectomy, laryngeal cancer, speech problems, swallowing problems, shoulder problems

Interventions

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 pro

Sponsors

VU University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
The primary outcome measure of this study is the swallowing quality of life questionnaire (SWAL-QoL).

Secondary

MeasureTime frame
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).

Contacts

Public ContactI.M. Verdonck-de Leeuw

PO Box 7057

im.verdonck@vumc.nl+31(0)20-4443690

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)