Therapeutic Resistance Group Exercise Training for Head & Neck Cancer Survivors (TARGET)

Evaluating Outcomes From a Combined Supervised Therapeutic and Physical Exercise Program for Post-surgical Head and Neck Cancer Survivors: A Randomized Controlled Trial

The investigators will conduct a randomized controlled trial examining 12-week, 24-week and one year outcomes from a combined therapeutic and physical exercise program that aims to bridge head-and-neck cancer survivors from acute care rehabilitation services to community-based exercise programming.

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms; Fatigue; Accessory Nerve Injury
• Intervention / Treatment: Behavioral: Therapeutic Exercise; Behavioral: Therapeutic + Lower Body Exercise

Detailed Description

Participants will be stratified by early (within 18 months of surgery) and late (> 18 months of surgery) and randomized on a one-on-one basis to (1) a supervised therapeutic exercise program for the neck and shoulder (serving as standard care) or (2) a combined therapeutic and lower body resistance exercise program. The randomization sequence will be generated by staff in the Rehabilitation Research Centre at Corbett Hall and placed in sealed opaque envelopes.

The exercise program will be offered in a group setting. Participants will exercise 2 times per week for a 10-week session and will have the option to continue for an additional 10-week maintenance session. The primary outcome for the study will be quality of life as measured by the Functional Assessment of Cancer Therapy (FACT)-Fatigue Scale at 12-weeks.

At each measurement point following the baseline assessment, including the 12-week and 24-week and one year follow-ups, an Independent Assessor will perform the objective fitness measurements. The Independent Assessor will also administer the Neck Dissection Impairment Questionnaire and the FACT-Fatigue quality of life questionnaires. The Physical Activity Adherence Diary will be collected by a Research Coordinator at each follow-up visit.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2G4
      • University of Alberta/ Cross Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Squamous cell carcinoma/ thyroid cancer/ melanoma or lymphoma involving: oral cavity, oropharynx, larynx or hypopharynx, or lymph nodes in the neck region
• Surgical treatment includes radical neck dissection, modified radical neck dissection and other variants of functional/selective neck dissection OR radiation therapy to lymph node regions
• Presenting with shoulder and/ or neck dysfunction related to cancer treatment
• Karnofsky Performance Status greater than or equal to 60%
• No evidence of residual cancer in the neck and no distant (M0) metastasis. Potential participants with symptoms suggestive of distant metastasis (M1) must have appropriate investigations (e.g. bone scan) to rule these out.
• Participants must have completed their head and neck/ thyroid/ melanoma/ lymphoma cancer treatment (minimum 4 weeks post treatment)
• Pre-participation Screening: Prior to participation in the exercise program, potential participants will complete general and cancer-specific Physical Activity Readiness Questionnaires (PAR-Q+) to determine appropriateness for the exercise program. Physician consent and approval for supervised exercise will be required prior to enrollment.

Exclusion Criteria:

• A participant will be ineligible if they present with medical illness or psychiatric illness, which, in the opinion of the investigators, would impact his/her ability to participate in exercise or interfere with follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Therapeutic Exercise; Therapeutic Exercise Program (standard care) will include: Neck range of motion and strengthening, and posture retraining.; Shoulder specific progressive resistance exercise program that focuses on spinal accessory nerve dysfunction and rehabilitation of trapezius muscle function.	Behavioral: Therapeutic Exercise; A specialized therapeutic exercise program to address neck and shoulder dysfunction due to spinal accessory nerve damage.
Experimental: Therapeutic + Lower Body Exercise; The Therapeutic Exercise Program (standard care) will include: Neck range of motion and strengthening, and posture retraining.; Shoulder specific progressive resistance exercise program that focuses on spinal accessory nerve dysfunction and rehabilitation of trapezius muscle function. The Resistance Exercise component will target 6-8 muscle groups of the lower extremities and core including gluteal, quadriceps, hamstrings, abdominals, and gastrocnemius muscles. A progressive introduction of exercises will occur over the first 3 weeks.; a personalized program of lower extremity resistance exercises; core strengthening exercises	Behavioral: Therapeutic Exercise; A specialized therapeutic exercise program to address neck and shoulder dysfunction due to spinal accessory nerve damage.; Behavioral: Therapeutic + Lower Body Exercise; A combined therapeutic exercise program (as per the comparison arm) plus the addition of lower body resistance exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Assessment of Cancer Therapy: Fatigue Scale Questionnaire	Cancer related fatigue	change from baseline to 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder range of motion in degrees.	Active and passive glenohumeral joint range of motion using standard 12 inch goniometer.	Change from baseline to one year
Body mass index	Derived from height and weight of the participant.	Change from baseline to 24 weeks.
1 repetition maximum (1RM) strength for seated row in pounds.	The maximal amount weight that can be pulled (seated row) and pushed (vertical bench) with proper form.	Change from baseline to 12 weeks.
Neck Range of Motion in degrees.	Measures of neck flexion, side flexion, rotations and extension using myrin goniometer.	Change from baseline to 12 weeks.
Upper extremity muscular endurance: number of repetitions performed.	Maximal repetitions to fatigue based on 50% of 1 repetition maximum strength for seated row.	baseline, 12-weeks, 24-weeks, one year
Lower extremity flexibility in centimetres.	Sit and reach test	Change from baseline to 12-weeks.
Functional capacity	6 minute walk test	Change from baseline to 24 weeks.
Neck Dissection Impairment Index	Neck dissection related quality of life	Change from baseline to one year.
Grip strength in pounds.	Maximal grip strength: composite score of both hands. Best of three attempts for each side.	Change from baseline to 12-weeks.
1 repetition maximum leg press in pounds	The maximal amount of weight that can be moved with proper	Change from baseline to 12 weeks.
1 repetition maximum chest press in pounds.	The maximal amount of weight that can be pushed with proper form.	Change from baseline to 12 weeks.
30 second sit to stand (optional: in lieu of leg press)	number of repetitions performed in 30 seconds	Change from baseline to 12 weeks.
Functional Assessment of Cancer Therapy Questionnaire Trial Outcome Index	The composite score of physical, functional and fatigue subscales of the questionnaire.	Baseline to 12-weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity level in minutes per week (average over the previous one month period).	Godin Leisure Time Questionnaire: minutes of mild, moderate and strenuous exercise.	Change in monthly average physical activity from baseline to one year.
Cost of programming	costs to programming, institution and participants	one year
Exercise Adherence	Adherence to exercise programming: attendance at supervised exercise sessions and self-directed sessions over the 1 year period.	Change from baseline to 1 year.
Functional Assessment of Cancer Therapy Fatigue Scale at one year.	Cancer-related fatigue.	Change from baseline to 1 year.

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Cross Cancer Institute
• Investigators: Principal Investigator: Margaret L. McNeely, PhD, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2016
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: December 28, 2015
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimated): January 6, 2016

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 31, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: exercise; physical therapy; cancer rehabilitation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Neoplasms by Site; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Cranial Nerve Diseases; Cranial Nerve Injuries; Accessory Nerve Diseases; Head and Neck Neoplasms; Accessory Nerve Injuries
• Other Study ID Numbers: HREBA.CC.15-0167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO