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

University of Alberta

Status: Completed

Conditions: Accessory Nerve Injury; Head and Neck Neoplasms; Fatigue

Treatments: Behavioral: Therapeutic + Lower Body Exercise; Behavioral: Therapeutic Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02647021

HREBA.CC.15-0167

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Therapeutic Exercise

Active Comparator group

Description:

Therapeutic Exercise Program (standard care) will include: 1. Neck range of motion and strengthening, and posture retraining. 2. Shoulder specific progressive resistance exercise program that focuses on spinal accessory nerve dysfunction and rehabilitation of trapezius muscle function.

Treatment:

Behavioral: Therapeutic Exercise

Therapeutic + Lower Body Exercise

Experimental group

Description:

The Therapeutic Exercise Program (standard care) will include: 1. Neck range of motion and strengthening, and posture retraining. 2. 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. 1. a personalized program of lower extremity resistance exercises 2. core strengthening exercises

Treatment:

Behavioral: Therapeutic Exercise

Behavioral: Therapeutic + Lower Body Exercise