Head and Neck CancerNCT04598087
Prehabilitation and Recovery After Head and Neck Cancer Surgery
A study testing Prehabilitation in people with Head and Neck Cancer and Head and Neck Neoplasms, run by University of Calgary at 1 site in Canada.
Trial summary
Implementing a multiphasic, multimodal prehabilitation intervention for people undergoing surgery with free flap reconstruction for the treatment of head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Neoplasms, Surgery
- What is being tested?
- Prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteCanada
- Study dates
- 9 Feb 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta
Rosie Twomey, PhD, 4039192061, rosemary.twomey@ucalgary.ca
About this study
Official title: Multiphasic Prehabilitation in Patients Undergoing Surgery for Head and Neck Cancer
Implementing a multiphasic, multimodal prehabilitation intervention for people undergoing surgery with free flap reconstruction for the treatment of head and neck cancer.
Read the 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.
- Conditions
- Head and Neck Cancer, Head and Neck Neoplasms, Surgery
- Being tested
- Prehabilitation
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | - Tailored exercise prescription involving aerobic and resistance training, supported by a clinical exercise physiologist. Receives: Behavioral: Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks, 6 months and 12 months after surgery (6 months is primary).
Secondary outcomes (18)
Weekly step counts
Total weekly step counts, measured using the Garmin vivosmart® 4
Measured: Phase 1 (before surgery)
Weekly "intensity minutes"
Total weekly "intensity minutes", measured using the Garmin vivosmart® 4
Measured: Phase 1 (before surgery)
Weekly step counts
Total weekly step counts. Garmin vivosmart® 4
Measured: Phase 3 (0-6 weeks after hospital discharge)
Weekly "intensity minutes"
Total weekly step counts, measured using the Garmin vivosmart® 4
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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
Measured: Before surgery, 6 weeks after surgery, 6 and 12 months follow-up
Functional exercise capacity (total steps)
Two-minute step test
Measured: 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.
Measured: 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.
Measured: Within 1 year after surgery.
Mobilization after surgery (i)
Mean daily step count. Garmin vivosmart® 4
Measured: The mean of the hospital period after surgery (typically 10-14 days)
Mobilization after surgery (ii)
Total daily step counts. Garmin vivosmart® 4
Measured: The in hospital period after surgery (typically 10-14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start9 Feb 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Culos-Reed, PhD, Principal investigator, nculosre@ucalgary.ca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598087
- Sponsor's protocol ID
- HREBA-CC-20-0013
- Status last verified
- Feb 2022
- First submitted
- 8 Oct 2020
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38012345
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiphasic Prehabilitation in Patients Undergoing Surgery for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT04598087
- Acronym / sponsor ID
- HREBA-CC-20-0013
- Conditions
- Head and Neck Cancer, Head and Neck Neoplasms, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Behavioral: Prehabilitation- Tailored exercise prescription involving aerobic and resistance training, supported by a clinical exercise physiologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrehabilitationThe 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. | Behavioural | Prehabilitation |
Primary outcome
Quality of life: Functional Assessment of Cancer Therapy-Head and Neck Version 4 (FACT-H&N)
Time frame: Baseline, 6 weeks, 6 months and 12 months after surgery (6 months is primary).
Total score ranges from 0-156. A higher score is a better outcome.
18 secondary outcomes
Weekly step counts
Time frame: Phase 1 (before surgery)
Weekly "intensity minutes"
Time frame: Phase 1 (before surgery)
Weekly step counts
Time frame: Phase 3 (0-6 weeks after hospital discharge)
Weekly "intensity minutes"
Time frame: Phase 3 (0-6 weeks after hospital discharge)
Self-reported moderate and strenuous physical activity score: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Time frame: 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)
Time frame: 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.
Time frame: Baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up
Anxiety score: Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up
Depression score: Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up
Symptom burden: Edmonton Symptom Assessment System (ERAS-r).
Time frame: 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
Time frame: Baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up
Single-leg balance (s)
Time frame: Before surgery, 6 weeks after surgery, 6 and 12 months follow-up
Lower-limb muscular endurance (number of sit-to-stands)
Time frame: Before surgery, 6 weeks after surgery, 6 and 12 months follow-up
Functional exercise capacity (total steps)
Time frame: Before surgery, 6 weeks after surgery, 6 and 12 months follow-up
Hospital length of stay (total number of days)
Time frame: The in-hospital period after surgery (from surgery to hospital discharge)
Number of complications
Time frame: Within 1 year after surgery.
Mobilization after surgery (i)
Time frame: The mean of the hospital period after surgery (typically 10-14 days)
Mobilization after surgery (ii)
Time frame: The in hospital period after surgery (typically 10-14 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Derived from this study: PubMed 38012345Wagoner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Culos-Reed, PhD principal investigator
nculosre@ucalgary.ca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Head and Neck Cancer and Head and Neck Neoplasms, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosemary C Twomey, PhD (+1 403-919-2061, rosemary.twomey@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life: Functional Assessment of Cancer Therapy-Head and Neck Version 4 (FACT-H&N) (time frame: Baseline, 6 weeks, 6 months and 12 months after surgery (6 months is primary).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04598087, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.