Trials / Terminated
TerminatedNCT03751449
Exercise and Nutrition Education in Improving Physical Function and Quality of Life in Older Breast Cancer Survivors
Exercise and Nutrition Intervention in Older Breast Cancer Survivors - The WIN CA Study
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Roswell Park Cancer Institute · Academic / Other
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Anatomic Stage I Breast Cancer AJCC v8
- Anatomic Stage IA Breast Cancer AJCC v8
- Anatomic Stage IB Breast Cancer AJCC v8
- Anatomic Stage II Breast Cancer AJCC v8
- Anatomic Stage IIA Breast Cancer AJCC v8
- Anatomic Stage IIB Breast Cancer AJCC v8
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Anatomic Stage IIIB Breast Cancer AJCC v8
- Anatomic Stage IIIC Breast Cancer AJCC v8
- Cancer Survivor
- Inactivity
- Obesity
- Overweight
- Prognostic Stage I Breast Cancer AJCC v8
- Prognostic Stage IA Breast Cancer AJCC v8
- Prognostic Stage IB Breast Cancer AJCC v8
- Prognostic Stage II Breast Cancer AJCC v8
- Prognostic Stage IIA Breast Cancer AJCC v8
- Prognostic Stage IIB Breast Cancer AJCC v8
- Prognostic Stage III Breast Cancer AJCC v8
- Prognostic Stage IIIA Breast Cancer AJCC v8
- Prognostic Stage IIIB Breast Cancer AJCC v8
- Prognostic Stage IIIC Breast Cancer AJCC v8
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Educational Intervention | Receive nutrition education |
| BEHAVIORAL | Exercise Intervention | Complete home-based aerobic and resistance exercise program |
| OTHER | Quality-of-Life Assessment | Ancillary studies |
| OTHER | Questionnaire Administration | Ancillary studies |
Timeline
- Start date
- 2019-03-25
- Primary completion
- 2021-05-01
- Completion
- 2021-05-21
- First posted
- 2018-11-23
- Last updated
- 2022-06-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03751449. Inclusion in this directory is not an endorsement.