Prehabilitation and Recovery After Head and Neck Cancer Surgery

NCT ID: NCT04598087

Last Updated: 2022-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-09
• Study Completion Date: 2024-12-31

Brief Summary

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

Detailed 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.

Conditions

Head and Neck Cancer; Head and Neck Neoplasms; Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Prehabilitation

\- Tailored exercise prescription involving aerobic and resistance training, supported by a clinical exercise physiologist.

Group Type: EXPERIMENTAL

Prehabilitation

Intervention Type: BEHAVIORAL

The multi-phasic prehabilitation intervention involves three phases: Phase 1: Before surgery (typically \~25 days); Phase 2: The in-hospital phase (typically 10-14 days); Phase 3: Discharge to 6-weeks after surgery.

Interventions

Prehabilitation

The multi-phasic prehabilitation intervention involves three phases: Phase 1: Before surgery (typically \~25 days); Phase 2: The in-hospital phase (typically 10-14 days); Phase 3: Discharge to 6-weeks after surgery.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicole Culos-Reed, PhD

Role: PRINCIPAL_INVESTIGATOR

nculosre@ucalgary.ca

Locations

University of Calgary

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Rosemary C Twomey, PhD

Role: CONTACT

rosemary.twomey@ucalgary.ca

+1 403-919-2061

Facility Contacts

Rosie Twomey, PhD

Role: primary

rosemary.twomey@ucalgary.ca

4039192061

References

Wagoner CW, Daun JT, Danyluk J, Twomey R, Murphy L, Peterson M, Gentleman E, Capozzi LC, Francis GJ, Chandarana SP, Hart RD, Matthews TW, McKenzie D, Matthews J, Nakoneshny SC, Schrag C, Sauro KM, Dort JC, Manaloto V, Burnett L, Chisholm A, Lau H, Culos-Reed SN. Multiphasic exercise prehabilitation for patients undergoing surgery for head and neck cancer: a hybrid effectiveness-implementation study protocol. Support Care Cancer. 2023 Nov 28;31(12):726. doi: 10.1007/s00520-023-08164-w.

Reference Type: DERIVED

PMID: 38012345 (View on PubMed)

Other Identifiers

HREBA-CC-20-0013

Identifier Type: -

Identifier Source: org_study_id