Prehabilitation and Recovery After Head and Neck Cancer Surgery
Primary Purpose
Head and Neck Cancer, Head and Neck Neoplasms, Surgery
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Prehabilitation
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Cancer
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)
Sites / Locations
- University of CalgaryRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prehabilitation
Arm Description
- Tailored exercise prescription involving aerobic and resistance training, supported by a clinical exercise physiologist.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Weekly step counts
Total weekly step counts, measured using the Garmin vivosmart® 4
Weekly "intensity minutes"
Total weekly "intensity minutes", measured using the Garmin vivosmart® 4
Weekly step counts
Total weekly step counts. Garmin vivosmart® 4
Weekly "intensity minutes"
Total weekly step counts, measured using the Garmin vivosmart® 4
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.
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.
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.
Anxiety score: Hospital Anxiety and Depression Scale (HADS)
Score ranges from 0-21, a higher score means more anxiety symptoms.
Depression score: Hospital Anxiety and Depression Scale (HADS)
Score ranges from 0-21, a higher score means more depressive symptoms.
Symptom burden: Edmonton Symptom Assessment System (ERAS-r).
Each item scored from 0 (no symptom) to 10 (worst possible symptom)
Self-reported health status: EQ VAS (visual analogue) score
Score ranges from 0 (worst health) to 100 (best health).
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.
Lower-limb muscular endurance (number of sit-to-stands)
Thirty second sit-to-stand test
Functional exercise capacity (total steps)
Two-minute step test
Hospital length of stay (total number of days)
Part of routine clinical data collection with the Calgary Head & Neck Enhanced Recovery Program.
Number of complications
Part of routine clinical data collection with the Calgary Head & Neck Enhanced Recovery Program.
Mobilization after surgery (i)
Mean daily step count. Garmin vivosmart® 4
Mobilization after surgery (ii)
Total daily step counts. Garmin vivosmart® 4
Full Information
NCT ID
NCT04598087
First Posted
October 8, 2020
Last Updated
February 18, 2022
Sponsor
University of Calgary
1. Study Identification
Unique Protocol Identification Number
NCT04598087
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Head and Neck Neoplasms, Surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prehabilitation
Arm Type
Experimental
Arm Description
- Tailored exercise prescription involving aerobic and resistance training, supported by a clinical exercise physiologist.
Intervention Type
Behavioral
Intervention Name(s)
Prehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of life: Functional Assessment of Cancer Therapy-Head and Neck Version 4 (FACT-H&N)
Description
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).
Secondary Outcome Measure Information:
Title
Weekly step counts
Description
Total weekly step counts, measured using the Garmin vivosmart® 4
Time Frame
Phase 1 (before surgery)
Title
Weekly "intensity minutes"
Description
Total weekly "intensity minutes", measured using the Garmin vivosmart® 4
Time Frame
Phase 1 (before surgery)
Title
Weekly step counts
Description
Total weekly step counts. Garmin vivosmart® 4
Time Frame
Phase 3 (0-6 weeks after hospital discharge)
Title
Weekly "intensity minutes"
Description
Total weekly step counts, measured using the Garmin vivosmart® 4
Time Frame
Phase 3 (0-6 weeks after hospital discharge)
Title
Self-reported moderate and strenuous physical activity score: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Description
[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
Title
Self-reported physical activity (leisure score index): Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Description
[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.
Time Frame
Baseline, 6 weeks after surgery, 6 and 12 months after cancer treatment
Title
Fatigue severity: Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F). Total score.
Description
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
Title
Anxiety score: Hospital Anxiety and Depression Scale (HADS)
Description
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
Title
Depression score: Hospital Anxiety and Depression Scale (HADS)
Description
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
Title
Symptom burden: Edmonton Symptom Assessment System (ERAS-r).
Description
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
Title
Self-reported health status: EQ VAS (visual analogue) score
Description
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
Title
Single-leg balance (s)
Description
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
Title
Lower-limb muscular endurance (number of sit-to-stands)
Description
Thirty second sit-to-stand test
Time Frame
Before surgery, 6 weeks after surgery, 6 and 12 months follow-up
Title
Functional exercise capacity (total steps)
Description
Two-minute step test
Time Frame
Before surgery, 6 weeks after surgery, 6 and 12 months follow-up
Title
Hospital length of stay (total number of days)
Description
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)
Title
Number of complications
Description
Part of routine clinical data collection with the Calgary Head & Neck Enhanced Recovery Program.
Time Frame
Within 1 year after surgery.
Title
Mobilization after surgery (i)
Description
Mean daily step count. Garmin vivosmart® 4
Time Frame
The mean of the hospital period after surgery (typically 10-14 days)
Title
Mobilization after surgery (ii)
Description
Total daily step counts. Garmin vivosmart® 4
Time Frame
The in hospital period after surgery (typically 10-14 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosemary C Twomey, PhD
Phone
+1 403-919-2061
Email
rosemary.twomey@ucalgary.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Culos-Reed, PhD
Organizational Affiliation
nculosre@ucalgary.ca
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosie Twomey, PhD
Phone
4039192061
Email
rosemary.twomey@ucalgary.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Prehabilitation and Recovery After Head and Neck Cancer Surgery
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