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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation | Experimental | - Tailored exercise prescription involving aerobic and resistance training, supported by a clinical exercise physiologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation | 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. |
| 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). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rosemary C Twomey, PhD | Contact | +1 403-919-2061 | rosemary.twomey@ucalgary.ca |
| Name | Affiliation | Role |
|---|---|---|
| Nicole Culos-Reed, PhD | nculosre@ucalgary.ca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Recruiting | Calgary | Alberta | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38012345 | Derived | 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. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| 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) |
| D015444 |
| Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |