Implementing a multiphasic, multimodal prehabilitation intervention for people undergoing surgery with free flap reconstruction for the treatment of head and neck cancer.
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
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
96
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.
University of Calgary
Calgary, Alberta, Canada
RECRUITINGQuality 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.
Time frame: Baseline, 6 weeks, 6 months and 12 months after surgery (6 months is primary).
Weekly step counts
Total weekly step counts, measured using the Garmin vivosmart® 4
Time frame: Phase 1 (before surgery)
Weekly "intensity minutes"
Total weekly "intensity minutes", measured using the Garmin vivosmart® 4
Time frame: Phase 1 (before surgery)
Weekly step counts
Total weekly step counts. Garmin vivosmart® 4
Time frame: Phase 3 (0-6 weeks after hospital discharge)
Weekly "intensity minutes"
Total weekly step counts, measured using the Garmin vivosmart® 4
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: Before surgery, 6 weeks after surgery, 6 and 12 months follow-up
Functional exercise capacity (total steps)
Two-minute step test
Time frame: 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.
Time frame: 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.
Time frame: Within 1 year after surgery.
Mobilization after surgery (i)
Mean daily step count. Garmin vivosmart® 4
Time frame: The mean of the hospital period after surgery (typically 10-14 days)
Mobilization after surgery (ii)
Total daily step counts. Garmin vivosmart® 4
Time frame: The in hospital period after surgery (typically 10-14 days)