Clinical trial NCT04598087: Prehabilitation and Recovery After Head and Neck Cancer Surgery
Official title: Multiphasic Prehabilitation in Patients Undergoing Surgery for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Cancer
Head and Neck Neoplasms
Surgery
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Quality of life: Functional Assessment of Cancer Therapy-Head and Neck Version 4 (FACT-H&N)
timeFrame: Baseline, 6 weeks, 6 months and 12 months after surgery (6 months is primary).
Secondary outcomes:
measure: Weekly step counts
timeFrame: Phase 1 (before surgery)
measure: Weekly "intensity minutes"
timeFrame: Phase 1 (before surgery)
measure: Weekly step counts
timeFrame: Phase 3 (0-6 weeks after hospital discharge)
measure: Weekly "intensity minutes"
timeFrame: Phase 3 (0-6 weeks after hospital discharge)
measure: Self-reported moderate and strenuous physical activity score: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
timeFrame: Pre-intervention, 6 weeks after surgery, 6 and 12 months after cancer treatment
measure: Self-reported physical activity (leisure score index): Godin Leisure-Time Exercise Questionnaire (GLTEQ)
timeFrame: Baseline, 6 weeks after surgery, 6 and 12 months after cancer treatment
measure: Fatigue severity: Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F). Total score.
timeFrame: Baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up
measure: Anxiety score: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up
measure: Depression score: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up
measure: Symptom burden: Edmonton Symptom Assessment System (ERAS-r).
timeFrame: Baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up
measure: Self-reported health status: EQ VAS (visual analogue) score
timeFrame: Baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up
measure: Single-leg balance (s)
timeFrame: Before surgery, 6 weeks after surgery, 6 and 12 months follow-up
measure: Lower-limb muscular endurance (number of sit-to-stands)
timeFrame: Before surgery, 6 weeks after surgery, 6 and 12 months follow-up
measure: Functional exercise capacity (total steps)
timeFrame: Before surgery, 6 weeks after surgery, 6 and 12 months follow-up
measure: Hospital length of stay (total number of days)
timeFrame: The in-hospital period after surgery (from surgery to hospital discharge)
measure: Number of complications
timeFrame: Within 1 year after surgery.
measure: Mobilization after surgery (i)
timeFrame: The mean of the hospital period after surgery (typically 10-14 days)
measure: Mobilization after surgery (ii)
timeFrame: The in hospital period after surgery (typically 10-14 days)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: nculosre@ucalgary.ca
name: Nicole Culos-Reed, PhD
role: PRINCIPAL_INVESTIGATOR
References: