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| ID | Type | Description | Link |
|---|---|---|---|
| 12-1975 | Other Identifier | UNC IRB |
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The study will look at conducting a medium-intense walking program called Walk With Ease with cancer patients age 60 and above who are starting chemotherapy treatment. We will measure how many of these patients complete their participation in this program.
The primary purpose of this study is to evaluate the feasibility of implementing a moderate-intensity walking program (Walk With Ease/WWE) among cancer patients, age ≥60 years, as they undergo cytotoxic chemotherapy treatment. Feasibility will be determined based on the rate of participation in the WWE program. As secondary objectives, we will also establish the rate of completion of a number of instruments, including a Geriatric Assessment tool, and other instruments that measure self-reported quality of life (e.g., fatigue, depression, and pain), and self-reported physical activity (PA). Data from these instruments, as well as from serial measurements of a biomarker of aging (p16INK4a) will be explored and used to inform future studies designed to evaluate any relationship between these variables and participation in the WWE program.
We propose a sample (n=30) of cancer patients ≥60 years of age with potentially curable cancer and a diagnosis of Stage I-III breast cancer, Stage I-III lung cancer, or Stage II-III colon cancer, who are about to begin chemotherapy. Participation will be defined as completing the 6-week WWE program. Results from this study will be used in an RO1 application to the National Cancer Institute (NCI) pertaining to PA interventions among cancer patients and the effects of biomarkers on prognosis and survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Cancer Patients 60+ | Breast Cancer Patients age 60 and older who have histologically confirmed stage I, II or III disease. |
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| Lung Cancer Patients 60+ | Lung Cancer Patients age 60 and above who have stage I, II or III disease |
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| Colon Cancer Patients 60+ | Colon cancer patients age 60 and above who have stage II or III disease. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walk With Ease Program | Behavioral | The primary activity required of study subjects is a 6-week self-directed (non-group) WWE walking program that study participants do at a place and time that is convenient for them. To start the intervention/program, we schedule a brief baseline meeting with study participants to discuss the program, provide the WWE workbook, secure printed informed consent, and complete various questionnaires. Study participants are also asked to maintain a daily walking diary that is provided to them. The WWE program includes a workbook with strengthening and stretching exercises, basic facts about arthritis and PA, and information on how to individualize the program. |
| Measure | Description | Time Frame |
|---|---|---|
| To measure the feasibility of implementing the WWE program among cancer patients, age ≥60, as they undergo cytotoxic chemotherapy treatment. | Feasibility will be defined as the proportion of recruited subjects who complete the 6-week WWE program. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To measure the rate of completion of each of the following questionnaires/assessments at 3 different time points | The rate of completion of assessments will be measured at baseline, 6 weeks and end of chemotherapy treatment. | 1 year |
| To measure relationships between physical activity levels and p16 levels. |
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Inclusion Criteria:
Exclusion Criteria:
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Colon, lung and breast cancer patients age 60 and above who are beginning chemotherapy or chemoradiation treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Hyman Muss, MD | University of North Carolina Lineberger Comprehensive Cancer Center | Principal Investigator |
| Kirsten A Nyrop, PhD | University of North Carolina Thurston Arthritis Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Cancer Hospital | Chapel Hill | North Carolina | 27514 | United States |
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| Label | URL |
|---|---|
| The Geriatric Oncology Research Program at UNC | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003110 | Colonic Neoplasms |
| D008175 | Lung Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D016138 | Walking |
| ID | Term |
|---|---|
| D008124 | Locomotion |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Whole Blood Sample
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| Collect Blood, GA and Other Survey Tools | Other |
Surveys included in study are listed above. Whole Blood Sample will be collected for p16 analysis. |
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To measure the association between number of minutes walked per day and number of times per week with p16 levels. |
| 1 year |
| D017437 |
| Skin and Connective Tissue Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |
| D015444 | Exercise |
| D009043 | Motor Activity |