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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01704 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| i 67518 | Other Identifier | Roswell Park Cancer Institute |
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This trial studies how well exercise and nutrition education work in improving physical function and quality of life in older breast cancer survivors. Exercise and nutrition education may help to improve the level of fitness, cardiovascular health, and quality of life in breast cancer survivors.
PRIMARY OBJECTIVES:
I. To assess the effect of a home-based aerobic and resistance exercise and nutrition education intervention in overweight or obese, sedentary, older (65 years and above) breast cancer survivors on physical function (6-minute walk test) and quality of life compared to standard of care.
SECONDARY OBJECTIVES:
I. To assess the effect of a home-based aerobic and resistance exercise and nutrition education intervention on diet quality, sleep, anxiety, depression, source of motivation for exercise, and immune function in overweight or obese, sedentary, older (65 years and above) breast cancer survivors compared to standard of care.
EXPLORATORY OBJECTIVES:
I. To determine how body composition (dual X-ray absorptiometry [DEXA]) and weight maintenance are affected by a 12-week aerobic and resistance exercise training program among older (65 years and above), sedentary, overweight and obese breast cancer survivors.
II. To compare differences in the above outcomes among older (65 years and above), sedentary, overweight and obese breast cancer survivors who completed a home-based aerobic and resistance exercise training program versus those who did not receive the intervention, standard of care.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I (ACTIVE TREATMENT): Participants complete a home-based aerobic and resistance exercise program and receive nutrition education for 12 weeks.
GROUP II (WAITLIST): Participants are placed on a waitlist for 12 weeks and then complete a home-based aerobic and resistance exercise program and receive nutrition education for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (active treatment) | Experimental | Participants complete a home-based aerobic and resistance exercise program and receive nutrition education for 12 weeks. |
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| Group II (waitlist) | Active Comparator | Participants are placed on a waitlist for 12 weeks and then complete a home-based aerobic and resistance exercise program and receive nutrition education for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Receive nutrition education |
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| Measure | Description | Time Frame |
|---|---|---|
| Activity levels for all participants will be collected using the Fitbit applications and a weekly activity log. | Will measure the effect on physical function (6-minute walk test). Activity levels for all participants will be collected using the Fitbit applications and/or a weekly activity log. | Up to 2 years |
| Quality of life as assessed by the Self Geriatric Assessment Measure (GA-Self Assessment) | Will measure the effect of a home-based aerobic and resistance exercise and nutrition education intervention on quality of life. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Diet quality as assessed by the ASA24 website | Will measure the effect of a home-based aerobic and resistance exercise and nutrition education intervention on diet quality. | Up to 2 years |
| Sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tracey O'Connor | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| Exercise Intervention | Behavioral | Complete home-based aerobic and resistance exercise program |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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The PSQI measures the quality and pattern of sleeps in adults. There are 19 items. Each item is weighted on a 0-3 interval scale. |
| Up to 2 years |
| Anxiety and the effect of a home-based aerobic and resistance exercise and nutrition education intervention | Will measure anxiety as assessed by the State Trait Anxiety Inventory (STAI-Y1)e STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety | Up to 2 years |
| motivation for exercise as assessed by the Behavioral Regulation for Exercise Questionnaire (BREQ-2) | A 19 item questionnaire that measures the stages of the self-determination continuum with respect to motivation to exercise with a 5 point Likert scale (0=not true for me, 4=very true for me) | Up to 2 years |
| Centers for Epidemiologic Studies Depression Scale (CESD-R) | A self reported 20 item scale that measures depressive symptoms. A higher score denotes greater depressive symptoms. | Up to 2 years |
| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
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