Prehabilitation and Recovery After Head and Neck Cancer Surgery

Not Applicable

Recruiting

• Conditions: Head and Neck Neoplasms; Surgery; Head and Neck Cancer
• Interventions: Behavioral: Prehabilitation

• Registration Number: NCT04598087
• Lead Sponsor: University of Calgary

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.

Study Timeline

• Study First Submitted: 2020-10-08
• Study First Submitted QC: 2020-10-16
• Study First Posted: 2020-10-22
• Status Verified: 2022-02
• Study Start: 2022-02-09
• Last Update Submitted: 2022-02-18
• Last Update Posted: 2022-03-07
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prehabilitation	Prehabilitation	- Tailored exercise prescription involving aerobic and resistance training, supported by a clinical exercise physiologist.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada