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

Thomas Jefferson University

Status: Completed

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

Treatments: Other: Medical Device Usage and Evaluation; Other: Quality of Life Assessment; Other: Questionnaire Administration; Behavioral: Behavioral Intervention; Other: Consultation; Other: Exercise Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04788264

108 27000 908059 (Other Grant/Funding Number)

JT 15554 (Other Identifier)

20D.775

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Arm I (exercise training, behavior modification)

Experimental group

Description:

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.

Treatment:

Other: Exercise Intervention

Behavioral: Behavioral Intervention

Other: Consultation

Other: Questionnaire Administration

Other: Quality of Life Assessment

Other: Medical Device Usage and Evaluation

Arm II (Fitbit, consultation)

Active Comparator group

Description:

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.

Treatment:

Other: Consultation

Other: Questionnaire Administration

Other: Quality of Life Assessment

Other: Medical Device Usage and Evaluation