Evaluating Outcomes From a Combined Supervised Therapeutic and Physical Exercise Program for Post-surgical Head and Neck Cancer Survivors: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Alberta
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Functional Assessment of Cancer Therapy: Fatigue Scale Questionnaire
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Therapeutic Exercise (Behavioral)
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
Intervention: Therapeutic Exercise (Behavioral)
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
Intervention: Therapeutic + Lower Body Exercise (Behavioral)
Outcomes
Primary Outcomes
Functional Assessment of Cancer Therapy: Fatigue Scale Questionnaire
Time Frame: change from baseline to 12 weeks.
Cancer related fatigue
Secondary Outcomes
- Functional capacity(Change from baseline to 24 weeks.)
- Upper extremity muscular endurance: number of repetitions performed.(baseline, 12-weeks, 24-weeks, one year)
- Lower extremity flexibility in centimetres.(Change from baseline to 12-weeks.)
- Neck Dissection Impairment Index(Change from baseline to one year.)
- 1 repetition maximum leg press in pounds(Change from baseline to 12 weeks.)
- Body mass index(Change from baseline to 24 weeks.)
- 1 repetition maximum chest press in pounds.(Change from baseline to 12 weeks.)
- Functional Assessment of Cancer Therapy Questionnaire Trial Outcome Index(Baseline to 12-weeks.)
- Shoulder range of motion in degrees.(Change from baseline to one year)
- Neck Range of Motion in degrees.(Change from baseline to 12 weeks.)
- Grip strength in pounds.(Change from baseline to 12-weeks.)
- 1 repetition maximum (1RM) strength for seated row in pounds.(Change from baseline to 12 weeks.)
- 30 second sit to stand (optional: in lieu of leg press)(Change from baseline to 12 weeks.)
Investigators
Margie McNeely
Associate Professor
University of Alberta