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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-02185 | Registry Identifier | NCI Trial ID | |
| 2013-0752 | Other Identifier | Institutional Review Board | |
| UW13034 | Other Identifier | University of Wisconsin Carbone Cancer Center | |
| P30CA014520 | U.S. NIH Grant/Contract | View source | |
| A534260 | Other Identifier | UW Madison | |
| SMPH\MEDICINE\HEM-ONC | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
This randomized pilot clinical trial studies exercise intervention in improving quality of life and exercise capacity and reducing inflammation and oxidative stress in patients with lung cancer and their support persons. Exercise therapy may help improve quality of life, may increase exercise capacity, and may reduce inflammation and oxidative stress in patients with lung cancer and their supporters.
PRIMARY OBJECTIVES:
I. Determine the effect of an eight-week exercise intervention on biomarkers of inflammation, oxidative stress, exercise capacity, and quality of life in lung cancer patients.
SECONDARY OBJECTIVES:
I. Determine the effect of an eight-week exercise intervention on markers of stress and quality of life in the support person of lung cancer patients.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM A: Patients and their support persons undergo a supervised combined aerobic exercise comprising walking, cycling, or video-based aerobics and strength training using resistance bands for 40 minutes 2 days a week at the University of Wisconsin Hospital and Clinic (UWHC) and 3 days a week at home over 8 weeks.
ARM B: Patients and their support persons undergo the usual care over 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (aerobic and exercise training) | Experimental | Patients and their support persons undergo a supervised combined aerobic exercise comprising walking, cycling, or video-based aerobics and strength training using resistance bands for 40 minutes 2 days a week at the UWHC and 3 days a week at home over 8 weeks. |
|
| Arm II (usual care) | Active Comparator | Patients and their support persons undergo the usual care over 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise intervention | Behavioral | Receive aerobic and exercise intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in biomarkers of inflammation | Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time. | Baseline up to 8 weeks |
| Change in oxidative damage as indicated by serum 8-hydroxydeoxyguanosine (8-oh-dG) | Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time. | Baseline up to 8 weeks |
| Change in time to walk 400 m | Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time. | Baseline up to 8 weeks |
| Change in physical well-being scores on the Functional Assessment of Cancer Therapy-Lung (FACT-L) | Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time. | Baseline up to 8 weeks |
| Change in functional well-being scores on the FACT-L | Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time. | Baseline up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in stress scores on the SF-36 | Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time. | Baseline up to 8 weeks |
| Change in quality-of-life scores on the SF-36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Toby Campbell | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW Health Oncology - 1 South Park | Madison | Wisconsin | 53715 | United States | ||
| University of Wisconsin, Madison |
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| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center | View source |
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| standard follow-up care | Procedure | Receive usual care |
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| quality-of-life assessment | Procedure | Ancillary studies |
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| laboratory biomarker analysis | Other | Correlative studies |
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Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time. |
| Baseline up to 8 weeks |
| Madison |
| Wisconsin |
| 53792 |
| United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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