Exercise Training and Behavioral Modification for the Improvement of Physical Activity in Head and Neck Cancer Patients Undergoing Cancer Treatment
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hypopharyngeal Carcinoma
- Head and Neck Carcinoma
- Laryngeal Carcinoma
- Lung Carcinoma
- Maxillary Sinus Carcinoma
- Oral Cavity Carcinoma
- Stage IVB Laryngeal Cancer AJCC v8
- Stage III Laryngeal Cancer AJCC v8
- Oropharyngeal Carcinoma
- Paranasal Sinus Carcinoma
- Sinonasal Carcinoma
- Stage IVC Laryngeal Cancer AJCC v8
- Stage I Laryngeal Cancer AJCC v8
- Stage IV Laryngeal Cancer AJCC v8
- Stage IVA Laryngeal Cancer AJCC v8
- Stage II Laryngeal Cancer AJCC v8
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04788264
- Collaborators
- Not Provided
- Investigators
- Not Provided