Head and Neck Cancer Survivors
Conditions
Keywords
Exercise, Rehabilitation, Survivorship
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.
Interventions
OTHERExercise
A combination of aerobic, resistance, balance and flexibility exercises will be included.
Sponsors
University of Dublin, Trinity College
Irish Cancer Society
St. James's Hospital, Ireland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Programme feasibility | From enrolment until end of study intervention at 10 weeks | Recruitment rates (percentage of eligible study population that consented to participation), programme adherence (number of prescribed supervised and unsupervised sessions completed), retention, acceptability of the intervention and adverse events. Reasons for attrition or non-compliance will be identified through qualitative evaluation with participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Neck Disability Index | From enrolment until end of study intervention at 10 weeks | The Neck Disability Index will assess neck pain. |
| Quality of Life | From enrolment until end of study intervention at 10 weeks | The functional assessment of cancer therapy head and neck questionnaire will be used to measure quality of life. The higher the score, the better the QOL. |
| Physical Function | From enrolment until end of study intervention at 10 weeks | The 30 second Sit to Stand test, hand grip strength and clinical frailty scale. 30 second Sit to Stand: higher score associated with better outcomes Hand Grip Strength: higher score associated with better outcomes Clinical Frailty Scale: Lower values are associated with better outcomes |
| Physical Activity | From enrolment until end of study intervention at 10 weeks | Self-reported physical activity will be collected using the Godin Leisure-Time Physical Activity Questionnaire. The GLTEQ is a 4-item self-administered questionnaire with the first three questions seeking information on the number of times one engages in mild, moderate and strenuous activity in bouts of at least 15 min duration in a typical week. Total leisure activity score is then calculated based on number of bouts at each intensity multiplied by 3, 5, and 9 metabolic equivalents and summed. A higher score means more physically active. |
| Cancer Related Fatigue | From enrolment until end of study intervention at 10 weeks | Brief Fatigue Inventory This 9-item scale assesses the severity and interference of fatigue based on a 0 (no fatigue) to 10 (greatest fatigue) scale |
| Oral Intake | From enrolment until end of study intervention at 10 weeks | The Functional Oral Intake Scale This scale reflects the functional oral intake of patients (1-7) where 7 indicates no restrictions to oral intake and better outcomes |
| Lymphoedema | From enrolment until end of study intervention at 10 weeks | Lymph Scanner |
Countries
Ireland
Contacts
PRINCIPAL_INVESTIGATORGrainne Sheill, PhD
University of Dublin, Trinity College
Outcome results
None listed