Head and Neck Cancer Rehabilitation: The CaRe Feasibility Study (CaRe)

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer Survivors
• Intervention / Treatment: Other: Exercise

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • School Of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise; Multi-modal exercise programme The 10-week multi-modal exercise programme will comprise of twice weekly online supervised group-based exercise sessions. Each exercise session will last approximately 1 hour and consist of a combination of aerobic, resistance and balance and flexibility exercises.	Other: Exercise; A combination of aerobic, resistance, balance and flexibility exercises will be included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Programme feasibility	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.	From enrolment until end of study intervention at 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Neck Disability Index	The Neck Disability Index will assess neck pain.	From enrolment until end of study intervention at 10 weeks
Quality of Life	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.	From enrolment until end of study intervention at 10 weeks
Physical Function	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	From enrolment until end of study intervention at 10 weeks
Physical Activity	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.	From enrolment until end of study intervention at 10 weeks
Cancer Related Fatigue	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	From enrolment until end of study intervention at 10 weeks
Oral Intake	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	From enrolment until end of study intervention at 10 weeks
Lymphoedema	Lymph Scanner	From enrolment until end of study intervention at 10 weeks

Collaborators and Investigators

• Sponsor: University of Dublin, Trinity College
• Collaborators: St. James's Hospital, Ireland; Irish Cancer Society
• Investigators: Principal Investigator: Grainne Sheill, PhD, University of Dublin, Trinity College

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Exercise; Survivorship
• Additional Relevant MeSH Terms: Behavior; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: 2247

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No