Heavy Lifting Strength Training in Head and Neck Cancer Survivors

Study Overview
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Brief Summary
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The LIFTING trial will examine the feasibility and safety of a heavy lifting strength training (HLST) program in head and neck cancer survivors (HNCS) at least 1 years post surgical neck dissection. The trial will determine whether this training style is safe and feasible in HNCS. Physical and psychosocial changes will also be reported.

Detailed Description
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RATIONALE Despite improvements in treatments, HNCS still endure numerous acute and chronic side effects. Strength training has been shown to manage some of these side effects but most interventions have involved light-to-moderate resistance training programs. HLST may produce better outcomes but it is unknown if such a weight training program is feasible and safe for HNCS. OBJECTIVE The primary aim of this proposed study is to examine the feasibility and safety of a HLST program in HNCS at least 1 year post-surgical neck dissection. METHODS This single arm feasibility study will recruit 15-20 HNCS to complete the HLST program 2 times per week. The primary feasibility outcomes will include the eligibility rate (with reasons for ineligibility), recruitment rate (with reasons for refusal), 1 repetition maximum testing rate (with reasons for not completing the test), program adherence (including attendance, dose modifications, and progression), and follow-up assessment rate (with reasons for drop out). The primary efficacy outcome will be strength gains from baseline. Secondary efficacy outcomes will include physical functioning, quality of life, fear of cancer recurrence, pain, body composition, anxiety, fatigue, stress, shoulder mobility, self-esteem, sleep, and motivation to engage in a HLST program. SIGNIFICANCE Weight training is an effective intervention in HNCS but the optimal weight training prescription is unknown. If heavy weight training is deemed safe and feasible in HNCS, it can be compared to light-to-moderate load weight training to determine if it is a better prescription for improving outcomes that are important to HNCS.

Official Title
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Feasibility and Safety of Heavy Lifting Strength Training in Head and Neck Cancer Survivors Post-Surgical Neck Dissection

Conditions
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Cancer of Head and Neck

Intervention / Treatment
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* Behavioral: Exercise Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: previously diagnosed with any subtype and stage of head and neck cancer at least one year post surgical neck dissection for head and neck cancer and showing full shoulder range of motion or recovery of the spinal accessory nerve adults ages 18 and older no unmanaged medical conditions, alcohol, and drug abuse approved for a heavy lifting strength training program by the treating surgeon and a certified exercise physiologist ability to understand and communicate in English Exclusion Criteria: having comorbidities or uncontrolled medical conditions that their referred clinicians indicate as inappropriate to participate in exercise

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm, safety and feasibility trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Intervention<br>Single exercise arm | Behavioral: Exercise Intervention<br>* Heavy Lifting Strength Training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Rate | Recruitment rate (with reasons for refusal). Recruitment minimum: 15 participants Recruitment maximum: 20 participants Higher number= better and more data | Over 12 weeks | 
| Muscular Strength | Change in muscular strength from baseline to postintervention with be assessed using maximal strength tests. Minimum: none Maximum: none Higher score= better strength | Changes from baseline to 12 weeks | 
| Program Adherence | Program adherence minimum: 80% Program adherence maximum: 100% Higher score= better adherence | Over 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical functioning | Assessed using the Neck Dissection Impairment Index (NDII) and maximum strength tests. Minimum: 40 Maximum: 100 Higher score= worse impairment | Changes from baseline to 12 weeks | 
| Fear of cancer recurrence | Assessed using the Fear of Cancer Recurrence Inventory (FCRI) Minimum: 0 Maximum: 36 Higher score= worse fear of cancer recurrence | Changes from baseline to 12 weeks | 
| Post Traumatic Growth after cancer | How cancer has changed an individual's life will be assessed using the Post Traumatic Growth Inventory (PTGI) Minimum: 0 Maximum: 105 Higher score= better (positive) post traumatic growth transformation | Changes from baseline to 12 weeks | 
| Waist to hip ratio (body composition) | Assessed using waist to hip ratio (WHR) measure. Minimum WHR: none Maximum WHR: none Higher score WHR= worse body composition | Changes from baseline to 12 weeks | 
| Anxiety | Assessed using the Spielberger State Trait Anxiety Inventory (STAI) Minimum: 20 Maximum: 80 Higher score= worse anxiety | Changes from baseline to 12 weeks | 
| Fatigue | Assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire Minimum: 0 Maximum: 52 Higher score=worse fatigue | Changes from baseline to 12 weeks | 
| Stress | Assessed using the Perceived Stress Scale (PSS) Minimum: 0 Maximum: 56 Higher score=worse perceived stress | Changes from baseline to 12 weeks | 
| Shoulder Mobility | Changes in shoulder mobility Minimum: 150 degrees (18-50 years); 130 degrees (over 50 years) Maximum: none Higher score= better mobility | Changes from baseline to 12 weeks | 
| Self-Esteem | Changes in level of self-esteem assessed using Rosenberg Self-Esteem (RSE) scale Minimum: 10 Maximum: 40 Higher score= better self-esteem | Changes from baseline to 12 weeks | 
| Sleep | Changes in sleep patterns assessed using the insomnia severity index (ISI) Minimum: 0 Maximum: 28 Higher score= worse insomnia | Changes from baseline to 12 weeks | 
| Motivation | Questions based on the theory of planned behaviour Minimum: 7 Maximum: 35 Higher score= better motivation | Changes from baseline to 12 weeks | 
| Cancer specific quality of life | Assessed using the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N Symptom Index) Minimum: 0 Maximum: 40 Higher score= worse head and neck cancer symptoms | Changes from baseline to 12 weeks | 
| Cancer Symptom Burden | Assessed using the revised Edmonton Symptom Assessment System (ESAS-r) Minimum: 0 Maximum: 100 Higher score= worse cancer symptoms | Changes from baseline to 12 weeks | 
| Height | Assessed using standing height without shoes. Minimum height: none Maximum height: none Taller: not specifically better or worse | Changes from baseline to 12 weeks | 
| Weight | Assessed using a digital scale without shoes. Minimum weight: none Maximum weight: none Higher weight: typically worse, but depends on other factors (ie. height, muscle mass, overall health status) | Changes from baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, neck dissection, strength training, survivors, exercise