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Prehabilitation and Recovery After Head and Neck Cancer Surgery

U

University of Calgary

Status

Enrolling

Conditions

Surgery
Head and Neck Neoplasms
Head and Neck Cancer

Treatments

Behavioral: Prehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT04598087
HREBA-CC-20-0013

Details and patient eligibility

About

Implementing a multiphasic, multimodal prehabilitation intervention for people undergoing surgery with free flap reconstruction for the treatment of head and neck cancer.

Full description

BACKGROUND: Head and neck cancer (HNC) is the 7th most common cancer worldwide, and treatment often involves surgery. HNC surgery is intensive, complications are common, and quality of life (QOL) is negatively impacted. Support must be expanded to not only help patients survive HNC but to recover faster and live well following surgery. Prehabilitation, or optimizing a patient's condition before surgery, is a key opportunity to integrate supportive care early in the clinical care pathway for this underserved patient group. RESEARCH DESIGN AND METHODS: Using a mixed-methods approach, the aims of this hybrid implementation-effectiveness study are to (i) implement a multiphasic exercise prehabilitation program for HNC patients in a real-world setting and describe factors influencing implementation across the phases; (ii) determine the safety and tolerability of a multiphasic exercise prehabilitation program for HNC patients; (iii) explore the potential benefits of a multiphasic exercise prehabilitation program for HNC patients, and (iv) build a systematic screening and referral pathway into exercise oncology resources post-operatively. Outcomes are detailed below and include patient-reported outcomes, physical function, mobility (step count) and hospital length of stay.

Enrollment

96 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Aged ≥18 years;
  • Histologically verified primary head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, or in lymph nodes of the neck from an unknown primary tumour
  • Scheduled to undergo oncologic resection or resection for benign disease with free flap reconstruction
  • Approval received from a clinical exercise physiologist (CSEP-CEP) and/or clinician
  • Ability to provide written informed consent and understand study information in English

Exclusion criteria

  • Neurological or musculoskeletal co-morbidity inhibiting exercise
  • Diagnosed psychotic, addictive, or major cognitive disorders
  • Severe coronary artery disease (Canadian Cardiovascular Society class III or greater)
  • Significant congestive heart failure (New York Heart Association class III or greater)

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

96 participants in 1 patient group

Prehabilitation
Experimental group
Description:
- Tailored exercise prescription involving aerobic and resistance training, supported by a clinical exercise physiologist.
Treatment:
Behavioral: Prehabilitation

Trial contacts and locations

1

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Central trial contact

Rosemary C Twomey, PhD

Data sourced from clinicaltrials.gov

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