Prehabilitation and Recovery After Head and Neck Cancer Surgery

February 18, 2022 updated by: University of Calgary

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prehabilitation
- Tailored exercise prescription involving aerobic and resistance training, supported by a clinical exercise physiologist.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks, 6 months and 12 months after surgery (6 months is primary).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weekly step counts
Time Frame: Phase 1 (before surgery)
Total weekly step counts, measured using the Garmin vivosmart® 4
Phase 1 (before surgery)
Weekly "intensity minutes"
Time Frame: Phase 1 (before surgery)
Total weekly "intensity minutes", measured using the Garmin vivosmart® 4
Phase 1 (before surgery)
Weekly step counts
Time Frame: Phase 3 (0-6 weeks after hospital discharge)
Total weekly step counts. Garmin vivosmart® 4
Phase 3 (0-6 weeks after hospital discharge)
Weekly "intensity minutes"
Time Frame: Phase 3 (0-6 weeks after hospital discharge)
Total weekly step counts, measured using the Garmin vivosmart® 4
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
[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
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
[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
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
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
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
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
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
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
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
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
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
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
Single-leg balance (s)
Time Frame: Before surgery, 6 weeks after surgery, 6 and 12 months follow-up
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
Lower-limb muscular endurance (number of sit-to-stands)
Time Frame: Before surgery, 6 weeks after surgery, 6 and 12 months follow-up
Thirty second sit-to-stand test
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
Two-minute step test
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)
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)
Number of complications
Time Frame: Within 1 year after surgery.
Part of routine clinical data collection with the Calgary Head & Neck Enhanced Recovery Program.
Within 1 year after surgery.
Mobilization after surgery (i)
Time Frame: The mean of the hospital period after surgery (typically 10-14 days)
Mean daily step count. Garmin vivosmart® 4
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)
Total daily step counts. Garmin vivosmart® 4
The in hospital period after surgery (typically 10-14 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Calgary

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicole Culos-Reed, PhD, nculosre@ucalgary.ca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 9, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HREBA-CC-20-0013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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