Exercise Training and Behavioral Modification for the Improvement of Physical Activity in Head and Neck Cancer Patients Undergoing Cancer Treatment

Study Overview
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Brief Summary
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This clinical trial evaluates the tolerability of a physical activity program in head and neck cancer patients who are undergoing cancer treatment. The goal of this trial is to give patients exercises prescribed by a physical therapist that they are able to complete regularly at home. Increasing physical activity may help patients reduce fatigue, improve mood, increase physical performance, and decrease joint pain.

Detailed Description
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PRIMARY OBJECTIVE: I. To compare the changes in physical activity between the control and intervention groups of patients with head and neck or lung cancer at 6-weeks and 12-weeks, compared to baseline. SECONDARY OBJECTIVES: I. To demonstrate the feasibility, engagement, retention, and acceptability of physical activity promotion (intervention) in patients with head and neck or lung cancer. II. To calculate the effect sizes for the differences between the control and intervention in daily changes in psychosocial outcomes at 6-weeks and 12-weeks, compared to baseline. EXPLORATORY OBJECTIVE: I. To calculate the effect sizes for the differences between the control and intervention in changes in immunomodulatory, metabolic and aging biomarkers at 6-weeks and 12-weeks, compared to baseline. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Beginning 1 week prior to start of intervention, patients receive a Fitbit to monitor physical activity for 13 weeks. Patients receive consultation and personalized exercise prescription from a physical therapist at baseline, and attend exercise training sessions with a physical therapist during weeks 1, 3, 6, 9, and 12. Patients also attend behavior modification sessions with a behavioral therapist that focus on goal setting and healthy behavior changes during weeks 2, 4, 5, 7, 8, 10, and 11. ARM II: Patients receive a Fitbit to monitor physical activity for 12 weeks. Patients also receive consultation from a physical therapist to assess physical performance at weeks 1, 6, and 12. After completion of study intervention, patients are followed up at 30 days. EXPLORATORY OBJECTIVE: I. To demonstrate the difference in the magnitude of physical activity improvements between the immunotherapy and chemo-immunotherapy patients. OUTLINE: Beginning 1 week prior to start of intervention, patients receive a Fitbit to monitor physical activity for 13 weeks. Patients receive consultation and personalized exercise prescription from a physical therapist at baseline, and attend exercise training sessions with a physical therapist during weeks 1, 3, 6, 9, and 12. Patients also attend behavior modification sessions with a behavioral therapist that focus on goal setting and healthy behavior changes during weeks 2, 4, 5, 7, 8, 10, and 11. After completion of study intervention, patients are followed up at 30 days.

Official Title
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A Pilot Study to Assess Feasibility of a Clinically Significant Increase in Physical Activity in Patients With Head and Neck Cancer Undergoing Active Treatment

Conditions
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Lung Carcinoma, Head and Neck Carcinoma, Hypopharyngeal Carcinoma, Laryngeal Carcinoma, Maxillary Sinus Carcinoma, Oral Cavity Carcinoma, Oropharyngeal Carcinoma, Paranasal Sinus Carcinoma, Sinonasal Carcinoma, Stage I Laryngeal Cancer AJCC v8, Stage II Laryngeal Cancer AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage IV Laryngeal Cancer AJCC v8, Stage IVA Laryngeal Cancer AJCC v8, Stage IVB Laryngeal Cancer AJCC v8, Stage IVC Laryngeal Cancer AJCC v8

Intervention / Treatment
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* Other: Medical Device Usage and Evaluation
* Other: Consultation
* Other: Exercise Intervention
* Behavioral: Behavioral Intervention
* Other: Questionnaire Administration
* Other: Quality of Life Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with head and neck cancer including cancers of the sinuses, oral cavity, oropharynx, hypopharynx, or larynx (all stages); therapeutically eligible to receive at least three months of immunotherapy Medically cleared by oncologist to engage in aerobic and resistance exercise intervention 18 years of age or older Access to a smartphone and have an active wi-fi connection at home Able to read and/or to speak English Able to comprehend and sign a written informed consent (no cognitive decline) Women of reproductive potential must have a negative serum or urine pregnancy test within the week prior to starting therapy Exclusion Criteria: Severe or unstable cardiopulmonary, metabolic, or renal disease as determined by the referring oncologist Unable to walk safely without physical assistance of another person Any condition that may limit the ability to comply with behavioral recommendations of the program Pregnant or planning a pregnancy

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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (exercise training, behavior modification)<br>Beginning 1 week prior to start of intervention, patients receive a Fitbit to monitor physical activity for 13 weeks. Patients receive consultation and personalized exercise prescription from a physical therapist at baseline, and attend exercise training sessions with a physical therapist during weeks 1, 3, 6, 9, and 12. Patients also attend behavior modification sessions with a behavioral therapist that focus on goal setting and healthy behavior changes during weeks 2, 4, 5, 7, 8, 10, and 11. | Other: Medical Device Usage and Evaluation<br>* Receive Fitbit<br>Other: Consultation<br>* Receive consultation from a physical therapist<br>* Other names: Consult;Other: Exercise Intervention<br>* Attend exercise training sessions<br>Behavioral: Behavioral Intervention<br>* Attend sessions with a behavioral therapist<br>* Other names: Behavior Conditioning Therapy;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Quality of Life Assessment<br>* Ancillary studies<br>|
| Active Comparator: Arm II (Fitbit, consultation)<br>Patients receive a Fitbit to monitor physical activity for 12 weeks. Patients also receive consultation from a physical therapist to assess physical performance at weeks 1, 6, and 12. | Other: Medical Device Usage and Evaluation<br>* Receive Fitbit<br>Other: Consultation<br>* Receive consultation from a physical therapist<br>* Other names: Consult;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Quality of Life Assessment<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fitbit-recorded average steps (moderate and/or intensive) per day, each day | Changes in physical activity of the intervention group at 6-weeks and 12-weeks, compared to baseline, using two-sample t-tests, respectively. Longitudinal models such as (non)linear mixed models or generalized estimating equation (GEE) models | Baseline to 12 weeks after physical activity promotion | 
| Change in Fitbit-recorded average steps (moderate and/or intensive) per day, each day | Changes in physical activity of the control group at 6-weeks and 12-weeks, compared to baseline, using two-sample t-tests, respectively. Longitudinal models such as (non)linear mixed models or generalized estimating equation (GEE) models | Baseline to 12 weeks after physical activity promotion | 
| Change in Fitbit-recorded average active minutes (moderate and/or intensive) per day, each day | time trend will be compared between control and intervention groups at 6-weeks and 12-weeks, compared to baseline, using two-sample t-tests, respectively. Longitudinal models such as (non)linear mixed models or generalized estimating equation (GEE) models | Baseline to 12 weeks after physical activity promotion |