Head and Neck Cancer Rehabilitation: The CaRe Feasibility Study

NCT06646861 | Completed

• 1 other identifier: 2247
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer Survivors

Keywords

Exercise; Rehabilitation; Survivorship

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The Neck Disability Index

  From enrolment until end of study intervention at 10 weeks

• Quality of Life

  From enrolment until end of study intervention at 10 weeks

• Physical Function

  From enrolment until end of study intervention at 10 weeks

• Physical Activity

  From enrolment until end of study intervention at 10 weeks

• Cancer Related Fatigue

  From enrolment until end of study intervention at 10 weeks

Study Arms (1)

Exercise

EXPERIMENTAL

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

Interventions

Exercise OTHER

A combination of aerobic, resistance, balance and flexibility exercises will be included.

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Dublin, Trinity College: lead
• Irish Cancer Society: collaborator
• St. James's Hospital, Ireland: collaborator

Study Sites (1)

School of Medicine

Dublin, Ireland

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Grainne Sheill, PhD

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Assistant Professor

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 17, 2024
• Study Start: November 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: September 30, 2025
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

IE (1)