NCT04598087

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 9, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 7, 2022

Status Verified

February 1, 2022

Enrollment Period

1.9 years

First QC Date

October 8, 2020

Last Update Submit

February 18, 2022

Conditions

Head and Neck CancerHead and Neck NeoplasmsSurgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 6 weeks, 6 months and 12 months after surgery (6 months is primary).

Secondary Outcomes (18)

  • Weekly step counts

    Phase 1 (before surgery)

  • Weekly "intensity minutes"

    Phase 1 (before surgery)

  • Weekly step counts

    Phase 3 (0-6 weeks after hospital discharge)

  • Weekly "intensity minutes"

    Phase 3 (0-6 weeks after hospital discharge)

  • Self-reported moderate and strenuous physical activity score: Godin Leisure-Time Exercise Questionnaire (GLTEQ)

    Pre-intervention, 6 weeks after surgery, 6 and 12 months after cancer treatment

  • +13 more secondary outcomes

Study Arms (1)

Prehabilitation

EXPERIMENTAL

\- Tailored exercise prescription involving aerobic and resistance training, supported by a clinical exercise physiologist.

Behavioral: Prehabilitation

Interventions

PrehabilitationBEHAVIORAL

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.

Prehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38012345DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Nicole Culos-Reed, PhD

    nculosre@ucalgary.ca

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosemary C Twomey, PhD

CONTACT

+1 403-919-2061rosemary.twomey@ucalgary.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2020

First Posted

October 22, 2020

Study Start

February 9, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

March 7, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)