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| ID | Type | Description | Link |
|---|---|---|---|
| JT 15554 | Other Identifier | JeffTrial Number | |
| 108 27000 908059 | Other Grant/Funding Number | Population Science Cancer Research Fund |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (exercise training, behavior modification) | Experimental | 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 (Fitbit, consultation) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Device Usage and Evaluation | Other | Receive Fitbit |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
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| Consultation | Other | Receive consultation from a physical therapist |
|
|
| Exercise Intervention | Other | Attend exercise training sessions |
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| Behavioral Intervention | Behavioral | Attend sessions with a behavioral therapist |
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| Questionnaire Administration | Other | Ancillary studies |
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| Quality of Life Assessment | Other | Ancillary studies |
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| ID | Term |
|---|---|
| D007012 | Hypopharyngeal Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D008444 | Maxillary Sinus Neoplasms |
| D009062 | Mouth Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D010255 | Paranasal Sinus Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D009669 | Nose Neoplasms |
| D009668 | Nose Diseases |
| D010254 | Paranasal Sinus Diseases |
| D009059 | Mouth Diseases |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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