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| Name | Class |
|---|---|
| Breast Cancer Research Foundation | OTHER |
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This study will look at the impact of a self-directed walking program on post-chemotherapy survivors experiencing fatigue. It is hypothesized that the walking program will help lessen fatigue.
The investiagors propose to evaluate the impact of a home-based self-directed walking program on post-chemotherapy fatigue among 150 cancer survivors age 65 and older -- Senior Physical Activity after Chemotherapy (S-PACT). Participants must have potentially curable cancer, moderate to severe fatigue (score of 4 or higher on the Brief Fatigue Inventory), currently exercise less than 120 minutes per week and have completed chemotherapy treatment (radiation treatment must also be completed if it is part of the patient's treatment plan) within the last 6 weeks. The design is a randomized controlled trial, with participants randomized to a 3-month physical activity program (intervention group) or to wait-list control (this group begins the walking program at 3 months post-randomization). The primary objective is to compare the change in fatigue scores from baseline to 3 months between the intervention and wait-list control groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | This arm will begin the Walk With Ease program after the completion of chemotherapy. |
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| Wait List Control | Active Comparator | The arm will begin the Walk With Ease program three months after completion of chemotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walk With Ease | Behavioral | Walk With Ease is the Arthritis Foundation's evidence-based walking intervention to help with fatigue and pain. The intervention is a self-directed program that helps guide participants in a safe and comfortable paced walking program with an ultimate goal of walking for 30 minutes a day, five days a week. |
| Measure | Description | Time Frame |
|---|---|---|
| To measure change in fatigue scores between intervention and wait list control arms from baseline to three months. | Change in fatigue will be measured using the FACIT-F. | Three months |
| Measure | Description | Time Frame |
|---|---|---|
| To measure change in fatigue scores between intervention and WLC arms from baseline to 3 months | This outcome will be measured by the Brief Fatigue Inventory | Three months |
| To report recruitment and retention in the study at 3 months |
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Inclusion Criteria:
Men and women age 65 years and older
Histologically or cytologically confirmed cancer (hematologic or solid) at stage considered amenable to cure as assessed by the treating MD
Within 6 weeks of end of chemotherapy (all participants must have had chemotherapy treatment)
Moderate to severe fatigue (>4 on BFI)
Less than 120 minutes/week of physical activity
English speaking
Signed IRB approved written informed consent
Approval from their treating physician to engage in moderate-intensity physical activity
Patient-assessed ability to walk and engage in moderate physical activity
Willing and able to meet all study requirements.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyman B Muss, MD | UNC Lineberger Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
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| Label | URL |
|---|---|
| UNC Geriatric Oncology Program | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D005221 | Fatigue |
| D001247 | Asthenia |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016138 | Walking |
| C034430 | methyl hydroxyethyl cellulose |
| ID | Term |
|---|---|
| D008124 | Locomotion |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
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| Three months |
| To report recruitment and retention in the study at 6 months | Six months |
| To measure implementation of and adherence to WWE | Six months |
| To count the number of adverse events | To characterize the safety of the walking program through a review of the number and type of adverse events, including falls, reported by study participants to the Study Team. | Six months |
| To measure change in engagement of walking over time from baseline to three months. | To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms. Engagement in walking (total minutes per week) as measured by engagement in physical activity questions | Three Months |
| To measure change in physical function over time from baseline to three months. | To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms. Physical function as measured by SPPB | Three Months |
| To measure change in quality of life over time from baseline to three months. | To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms. Quality of life as measured by FACT-G (global and subscales) and symptom scales, including PROMIS pain intensity, sleep disturbance and depression. | Three Months |
| To measure change in self-efficacy over time from baseline to three months. | To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms. Engagement in walking (total minutes per week) as measured by engagement in physical activity questions | Three Months |
| D015444 | Exercise |
| D009043 | Motor Activity |