Head and Neck Cancer Rehabilitation: the CaRe Feasibility Study

Not Applicable

Not yet recruiting

• Conditions: Head and Neck Cancer Survivors

• Registration Number: NCT06646861
• Lead Sponsor: University of Dublin, Trinity College

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-15
• Last Update Submitted: 2024-10-15
• Study First Posted: 2024-10-17
• Last Update Posted: 2024-10-17
• Study Start: 2024-11-01
• Primary Completion: 2025-07-31
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

• Individuals with moderate or severe cognitive impairment
• Pregnancy
• Receiving treatment in the palliative setting

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

School of Medicine; 🇮🇪 Dublin, Ireland