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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study evaluates the feasibility and preliminary effects of a home based exercise and activity program for individuals with cancer. Participants will engage in a structured intervention designed to support physical activity and symptom management. The study will assess changes in patient reported outcomes, functional measures, and overall adherence to the program. Findings will help determine whether this approach is practical and potentially beneficial for improving health related outcomes in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXCAP-hEAT Intervention | Experimental | Participants will complete a 6-week home-based combined lifestyle intervention consisting of a structured exercise program (EXCAP) and a self-selected 10-hour daily healthy eating timeframe. The intervention includes aerobic walking, progressive resistance band training, and daily tracking of eating timeframes and physical activity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXCAP Exercise Program | Behavioral | Home-based walking prescription with progressive 5% weekly step increase and resistance band training performed at least twice per week over 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Meeting Pre-Specified Adherence Criteria | Percentage of participants who meet all three adherence criteria during the 6-week intervention: Maintain a ≤10-hour eating timeframe on at least 50 percent of intervention days (21 of 42 days) Complete resistance band exercises at least 12 total sessions during the 6-week period Increase average weekly step count by at least 20 percent from baseline to Week 6 | Baseline to Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Brief Fatigue Inventory Total Score | Mean difference in total BFI score from baseline (Day 0) to post-intervention (Day 42). Higher scores indicate greater fatigue. | Baseline to Day 42 |
| Mean Change in Multidimensional Fatigue Symptom Inventory Total Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lindsey Mattick, PhD | Contact | 5852740473 | Lindsey_Mattick@urmc.rochester.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lindsey Mattick, PhD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilmot Cancer Institute | Rochester | New York | 14642 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 10-Hour Healthy Eating Timeframe (hEAT) | Behavioral | Participants will self-select and maintain a daily eating window of 10 hours or less for 6 weeks, with timing of first and last meals recorded daily. |
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Mean difference in total MFSI score from baseline (Day 0) to post-intervention (Day 42). Higher scores indicate greater fatigue burden. |
| Baseline to Day 42 |
| Mean Change in Body Mass Index | Mean difference in BMI (kg/m²) measured at baseline and at Day 42. | Baseline to Day 42 |
| Mean Change in 30-Second Bicep Curl Test Repetitions | Mean difference in total number of completed bicep curl repetitions within 30 seconds from baseline to Day 42. | Baseline to Day 42 |
| Mean Change in 30-Second Chair Stand Test Repetitions | Mean difference in total number of completed chair stands within 30 seconds from baseline to Day 42. | Baseline to Day 42 |
| Mean Change in Estimated Submaximal VO2 | Mean difference in estimated VO2submax (mL/kg/min) obtained from treadmill testing at baseline and Day 42. | Baseline to Day 42 |
| D017437 |
| Skin and Connective Tissue Diseases |