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Prehabilitation and Recovery After Head and Neck Cancer Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04598087
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : March 7, 2022
Sponsor:
Information provided by (Responsible Party):
University of Calgary

Study Description
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Brief Summary:
Implementing a multiphasic, multimodal prehabilitation intervention for people undergoing surgery with free flap reconstruction for the treatment of head and neck cancer.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Head and Neck Neoplasms Surgery Behavioral: Prehabilitation Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Multiphasic Prehabilitation in Patients Undergoing Surgery for Head and Neck Cancer
Actual Study Start Date : February 9, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Weekly step counts [ Time Frame: Phase 1 (before surgery) ]
    Total weekly step counts, measured using the Garmin vivosmart® 4

  2. Weekly "intensity minutes" [ Time Frame: Phase 1 (before surgery) ]
    Total weekly "intensity minutes", measured using the Garmin vivosmart® 4

  3. Weekly step counts [ Time Frame: Phase 3 (0-6 weeks after hospital discharge) ]
    Total weekly step counts. Garmin vivosmart® 4

  4. Weekly "intensity minutes" [ Time Frame: Phase 3 (0-6 weeks after hospital discharge) ]
    Total weekly step counts, measured using the Garmin vivosmart® 4

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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)

  11. 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).

  12. 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.

  13. 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

  14. Functional exercise capacity (total steps) [ Time Frame: Before surgery, 6 weeks after surgery, 6 and 12 months follow-up ]
    Two-minute step test

  15. 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.

  16. Number of complications [ Time Frame: Within 1 year after surgery. ]
    Part of routine clinical data collection with the Calgary Head & Neck Enhanced Recovery Program.

  17. 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

  18. Mobilization after surgery (ii) [ Time Frame: The in hospital period after surgery (typically 10-14 days) ]
    Total daily step counts. Garmin vivosmart® 4


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04598087


Contacts
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Contact: Rosemary C Twomey, PhD +1 403-919-2061 rosemary.twomey@ucalgary.ca

Locations
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Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada
Contact: Rosie Twomey, PhD    4039192061    rosemary.twomey@ucalgary.ca   
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Nicole Culos-Reed, PhD nculosre@ucalgary.ca
More Information
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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT04598087    
Other Study ID Numbers: HREBA-CC-20-0013
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: March 7, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms