Accessory Nerve Injury, Fatigue, Head and Neck Neoplasms
Conditions
Keywords
physical therapy, cancer rehabilitation, exercise
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.
Interventions
BEHAVIORALTherapeutic Exercise
A specialized therapeutic exercise program to address neck and shoulder dysfunction due to spinal accessory nerve damage.
BEHAVIORALTherapeutic + Lower Body Exercise
A combined therapeutic exercise program (as per the comparison arm) plus the addition of lower body resistance exercise
Sponsors
Cross Cancer Institute
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Cancer Therapy: Fatigue Scale Questionnaire | change from baseline to 12 weeks. | Cancer related fatigue |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lower extremity flexibility in centimetres. | Change from baseline to 12-weeks. | Sit and reach test |
| 1 repetition maximum leg press in pounds | Change from baseline to 12 weeks. | The maximal amount of weight that can be moved with proper |
| 1 repetition maximum chest press in pounds. | Change from baseline to 12 weeks. | The maximal amount of weight that can be pushed with proper form. |
| 30 second sit to stand (optional: in lieu of leg press) | Change from baseline to 12 weeks. | number of repetitions performed in 30 seconds |
| Functional Assessment of Cancer Therapy Questionnaire Trial Outcome Index | Baseline to 12-weeks. | The composite score of physical, functional and fatigue subscales of the questionnaire. |
| Shoulder range of motion in degrees. | Change from baseline to one year | Active and passive glenohumeral joint range of motion using standard 12 inch goniometer. |
| Body mass index | Change from baseline to 24 weeks. | Derived from height and weight of the participant. |
| 1 repetition maximum (1RM) strength for seated row in pounds. | Change from baseline to 12 weeks. | The maximal amount weight that can be pulled (seated row) and pushed (vertical bench) with proper form. |
| Neck Range of Motion in degrees. | Change from baseline to 12 weeks. | Measures of neck flexion, side flexion, rotations and extension using myrin goniometer. |
| Upper extremity muscular endurance: number of repetitions performed. | baseline, 12-weeks, 24-weeks, one year | Maximal repetitions to fatigue based on 50% of 1 repetition maximum strength for seated row. |
| Functional capacity | Change from baseline to 24 weeks. | 6 minute walk test |
| Neck Dissection Impairment Index | Change from baseline to one year. | Neck dissection related quality of life |
| Grip strength in pounds. | Change from baseline to 12-weeks. | Maximal grip strength: composite score of both hands. Best of three attempts for each side. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exercise Adherence | Change from baseline to 1 year. | Adherence to exercise programming: attendance at supervised exercise sessions and self-directed sessions over the 1 year period. |
| Functional Assessment of Cancer Therapy Fatigue Scale at one year. | Change from baseline to 1 year. | Cancer-related fatigue. |
| Cost of programming | one year | costs to programming, institution and participants |
| Physical activity level in minutes per week (average over the previous one month period). | Change in monthly average physical activity from baseline to one year. | Godin Leisure Time Questionnaire: minutes of mild, moderate and strenuous exercise. |
Countries
Canada
Outcome results
None listed