Prehabilitation and Recovery After Head and Neck Cancer Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Head and Neck Cancer
- Head and Neck Neoplasms
- Surgery
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 fa...
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: This study is a prospective randomized controlled trial with a two-armed parallel design and 1:1 allocation ratio. The prehabilitation intervention will be multiphasic (before surgery, during the inpatient period, and after discharge) and multimodal (exercise and nutrition components). The primary objective is to determine the effect of prehabilitation compared to usual care on the co-primary outcomes of perioperative mobilization (step count measured using actigraphy) and QOL (Functional Assessment of Cancer Therapy-Head and Neck). The hypothesis is that both mobilization (in-hospital and in early recovery) and QOL (six months after surgery) will be significantly improved in the prehabilitation group, in comparison to usual care. The secondary objective is to examine the effect of prehabilitation compared to usual care on secondary outcomes including (i) hospital length of stay and complications; (ii) functional/fitness outcomes (including functional exercise capacity measured using the six-minute walk test); (iii) patient-reported outcomes including fatigue, anxiety and depression. DISCUSSION: This will be the first trial to assess the effectiveness of a multiphasic prehabilitation intervention for patients undergoing HNC surgery.
Tracking Information
- NCT #
- NCT04598087
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Nicole Culos-Reed, PhD nculosre@ucalgary.ca