Prehabilitation and Recovery After Head and Neck Cancer Surgery

Multiphasic Prehabilitation in Patients Undergoing Surgery for Head and Neck Cancer

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

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Head and Neck Neoplasms; Surgery
• Intervention / Treatment: Behavioral: Prehabilitation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rosemary C Twomey, PhD; Phone Number: +1 403-919-2061; Email: rosemary.twomey@ucalgary.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Recruiting
      • University of Calgary
      • Contact: Rosie Twomey, PhD; Phone Number: 4039192061; Email: rosemary.twomey@ucalgary.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

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: Prehabilitation; - Tailored exercise prescription involving aerobic and resistance training, supported by a clinical exercise physiologist.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life: Functional Assessment of Cancer Therapy-Head and Neck Version 4 (FACT-H&N)	Total score ranges from 0-156. A higher score is a better outcome.	Baseline, 6 weeks, 6 months and 12 months after surgery (6 months is primary).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekly step counts	Total weekly step counts, measured using the Garmin vivosmart® 4	Phase 1 (before surgery)
Weekly "intensity minutes"	Total weekly "intensity minutes", measured using the Garmin vivosmart® 4	Phase 1 (before surgery)
Weekly step counts	Total weekly step counts. Garmin vivosmart® 4	Phase 3 (0-6 weeks after hospital discharge)
Weekly "intensity minutes"	Total weekly step counts, measured using the Garmin vivosmart® 4	Phase 3 (0-6 weeks after hospital discharge)
Self-reported moderate and strenuous physical activity score: Godin Leisure-Time Exercise Questionnaire (GLTEQ)	[moderate frequency per week × 5] + [strenuous frequency per week × 9]. A higher score indicates more physical activity. The minimum score is 0, the maximum is dependent on the participant's frequency of physical activity.	Pre-intervention, 6 weeks after surgery, 6 and 12 months after cancer treatment
Self-reported physical activity (leisure score index): Godin Leisure-Time Exercise Questionnaire (GLTEQ)	[mild frequency per week × 3] + [moderate frequency per week × 5] + [strenuous frequency per week × 9]. A higher score indicates more physical activity. The minimum score is 0, the maximum is dependent on the participant's frequency of physical activity.	Baseline, 6 weeks after surgery, 6 and 12 months after cancer treatment
Fatigue severity: Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F). Total score.	Total score ranges from 0-52. Higher score means lower fatigue severity.	Baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up
Anxiety score: Hospital Anxiety and Depression Scale (HADS)	Score ranges from 0-21, a higher score means more anxiety symptoms.	Baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up
Depression score: Hospital Anxiety and Depression Scale (HADS)	Score ranges from 0-21, a higher score means more depressive symptoms.	Baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up
Symptom burden: Edmonton Symptom Assessment System (ERAS-r).	Each item scored from 0 (no symptom) to 10 (worst possible symptom)	Baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up
Self-reported health status: EQ VAS (visual analogue) score	Score ranges from 0 (worst health) to 100 (best health).	Baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up
Single-leg balance (s)	Timed single-limb stance, both legs where tolerable, eyes open and closed where tolerable, up to a maximum of 45 seconds.	Before surgery, 6 weeks after surgery, 6 and 12 months follow-up
Lower-limb muscular endurance (number of sit-to-stands)	Thirty second sit-to-stand test	Before surgery, 6 weeks after surgery, 6 and 12 months follow-up
Functional exercise capacity (total steps)	Two-minute step test	Before surgery, 6 weeks after surgery, 6 and 12 months follow-up
Hospital length of stay (total number of days)	Part of routine clinical data collection with the Calgary Head & Neck Enhanced Recovery Program.	The in-hospital period after surgery (from surgery to hospital discharge)
Number of complications	Part of routine clinical data collection with the Calgary Head & Neck Enhanced Recovery Program.	Within 1 year after surgery.
Mobilization after surgery (i)	Mean daily step count. Garmin vivosmart® 4	The mean of the hospital period after surgery (typically 10-14 days)
Mobilization after surgery (ii)	Total daily step counts. Garmin vivosmart® 4	The in hospital period after surgery (typically 10-14 days)

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Nicole Culos-Reed, PhD, nculosre@ucalgary.ca

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 7, 2022
• Last Update Submitted That Met QC Criteria: February 18, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: HREBA-CC-20-0013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No