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Trial Title:
Head and Neck Cancer Rehabilitation: the CaRe Feasibility Study
NCT ID:
NCT06646861
Condition:
Head and Neck Cancer Survivors
Conditions: Official terms:
Head and Neck Neoplasms
Conditions: Keywords:
Exercise
Rehabilitation
Survivorship
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Exercise
Description:
A combination of aerobic, resistance, balance and flexibility exercises will be included.
Arm group label:
Exercise
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 (n=29) 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. James's 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Informed Consent
- Over 18 years old
- In the first two years after treatment for head and neck cancer
- Medically fit to participate in low to moderate physical activity
Exclusion Criteria:
- Individuals with moderate or severe cognitive impairment
- Pregnancy
- Receiving treatment in the palliative setting
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
School of Medicine
Address:
City:
Dublin
Country:
Ireland
Contact:
Last name:
Grainne Sheill, PhD
Phone:
+353879403733
Email:
sheillg@tcd.ie
Contact backup:
Last name:
Kelly Coghlan-Lynch, MSc
Phone:
+353877827525
Email:
KCoghlan@stjames.ie
Contact backup:
Last name:
Grainne Sheill, PhD
Start date:
November 1, 2024
Completion date:
September 30, 2025
Lead sponsor:
Agency:
University of Dublin, Trinity College
Agency class:
Other
Collaborator:
Agency:
Irish Cancer Society
Agency class:
Other
Collaborator:
Agency:
St. James's Hospital, Ireland
Agency class:
Other
Source:
University of Dublin, Trinity College
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06646861
