Clinical trial NCT06646861: Head and Neck Cancer Rehabilitation: the CaRe Feasibility Study
Official title: Head and Neck Cancer Rehabilitation: the CaRe Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Head and Neck Cancer Survivors
Keywords: Exercise
Rehabilitation
Survivorship
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: Irish Cancer Society
name: St. James's Hospital, Ireland
First posted: 2024-10-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_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 (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.


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

Primary outcomes:
measure: Programme feasibility
timeFrame: From enrolment until end of study intervention at 10 weeks
Secondary outcomes:
measure: The Neck Disability Index
timeFrame: From enrolment until end of study intervention at 10 weeks
measure: Quality of Life
timeFrame: From enrolment until end of study intervention at 10 weeks
measure: Physical Function
timeFrame: From enrolment until end of study intervention at 10 weeks
measure: Physical Activity
timeFrame: From enrolment until end of study intervention at 10 weeks
measure: Cancer Related Fatigue
timeFrame: From enrolment until end of study intervention at 10 weeks
measure: Oral Intake
timeFrame: From enrolment until end of study intervention at 10 weeks
measure: Lymphoedema
timeFrame: From enrolment until end of study intervention at 10 weeks
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: School of Medicine
Study officials:
affiliation: University of Dublin, Trinity College
name: Grainne Sheill, PhD
role: PRINCIPAL_INVESTIGATOR
References: