Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646861
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Head and Neck Cancer Rehabilitation the CaRe Feasibility Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Head and Neck Cancer Rehabilitation the CaRe Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CaRe
Brief Summary:
Introduction As both the number of cancer survivors and the length of survival time are increasing long-term health issues related to cancer and its treatment are becoming more prevalent Research suggests that exercise can mitigate a number of negative health consequences of head and neck cancer and improve physical function and quality of life Multi-modal exercise interventions have been proposed as a cornerstone for survivorship care However studies evaluating exercise programmes in head and neck cancer populations are lacking
Purpose To evaluate the feasibility and acceptability of a multi-modal exercise rehabilitation programme for survivors of head and neck cancer in a real-world standard practice setting
Methods and analysis In this single-arm prospective feasibility study survivors of head and neck cancer n29 will undergo a 10-week multi-modal exercise programme The study population will comprise of cancer survivors attending outpatient services in an Irish national cancer centre Participants will be aged 18 or older and have completed treatment with curative intent
Feasibility will be evaluated in terms of recruitment adherence and compliance to the programme Secondary outcomes will examine physical function and quality of life measures In addition the acceptability of the programme will be assessed through patient feedback
Ethics and dissemination Ethical approval is pending from the St Jamess Hospital and Tallaght University Hospital Research and Ethics Committee The study results will be used to optimise the intervention content and may serve as the foundation for a larger definitive trial Results will be disseminated through peer-review journals congresses and relevant clinical groups
Purpose To evaluate the feasibility and acceptability of a multi-modal exercise rehabilitation programme for survivors of head and neck cancer in a real-world standard practice setting
Methods and analysis In this single-arm prospective feasibility study survivors of head and neck cancer n29 will undergo a 10-week multi-modal exercise programme The study population will comprise of cancer survivors attending outpatient services in an Irish national cancer centre Participants will be aged 18 or older and have completed treatment with curative intent
Feasibility will be evaluated in terms of recruitment adherence and compliance to the programme Secondary outcomes will examine physical function and quality of life measures In addition the acceptability of the programme will be assessed through patient feedback
Ethics and dissemination Ethical approval is pending from the St Jamess Hospital and Tallaght University Hospital Research and Ethics Committee The study results will be used to optimise the intervention content and may serve as the foundation for a larger definitive trial Results will be disseminated through peer-review journals congresses and relevant clinical groups
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None