Prehabilitation and Recovery After Head and Neck Cancer Surgery

Surgery Clinical Trial

Official title:

Multiphasic Prehabilitation in Patients Undergoing Surgery for Head and Neck Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04598087
• Other study ID #: HREBA-CC-20-0013
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2022
• Source: University of Calgary
• Contact: Rosemary C Twomey, PhD
• Phone: +1 403-919-2061
• Email: rosemary.twomey[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Surgery

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Weekly step counts	Total weekly step counts, measured using the Garmin vivosmart® 4	Phase 1 (before surgery)
Secondary	Weekly "intensity minutes"	Total weekly "intensity minutes", measured using the Garmin vivosmart® 4	Phase 1 (before surgery)
Secondary	Weekly step counts	Total weekly step counts. Garmin vivosmart® 4	Phase 3 (0-6 weeks after hospital discharge)
Secondary	Weekly "intensity minutes"	Total weekly step counts, measured using the Garmin vivosmart® 4	Phase 3 (0-6 weeks after hospital discharge)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Functional exercise capacity (total steps)	Two-minute step test	Before surgery, 6 weeks after surgery, 6 and 12 months follow-up
Secondary	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)
Secondary	Number of complications	Part of routine clinical data collection with the Calgary Head & Neck Enhanced Recovery Program.	Within 1 year after surgery.
Secondary	Mobilization after surgery (i)	Mean daily step count. Garmin vivosmart® 4	The mean of the hospital period after surgery (typically 10-14 days)
Secondary	Mobilization after surgery (ii)	Total daily step counts. Garmin vivosmart® 4	The in hospital period after surgery (typically 10-14 days)