Lifestyle Program (Scalable Nutrition and Physical Activity) for the Improvement of Nutrition and Physical Activity in Stage 0-III Breast Cancer Survivors
NCT04200482 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2021-11-04
Summary
The purpose of this phase II trial is to identify the most effective dose level (number of classes) of a diet and physical activity lifestyle program based on how well it improves diet and physical activity in stage 0-III breast cancer survivors. Study results may provide researchers with information on how to best implement diet and physical activity recommendations among breast cancer survivors.
Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8
- 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
- Prognostic Stage 0 Breast Cancer AJCC v8
- 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
- BEHAVIORAL
-
One Diet and Physical Activity Session
Attend 1 remote diet and physical activity session
- OTHER
-
Electronic (e) Health (eHealth) Communication Intervention
Receive eHealth communication intervention
- BEHAVIORAL
-
Twelve Diet and Physical Activity Group Sessions
Attend 12 remote diet and physical activity sessions in 6 months
- OTHER
-
Questionnaire Administration
Ancillary studies
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
Sponsors & Collaborators
-
Breast Cancer Research Foundation
collaborator OTHER -
Fred Hutchinson Cancer Center
lead OTHER
Principal Investigators
-
Nancy E Davidson · Fred Hutch/University of Washington Cancer Consortium
-
Heather Greenlee · Fred Hutch/University of Washington Cancer Consortium
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-02-21
- Primary Completion
- 2021-08-24
- Completion
- 2021-10-28
Countries
- United States
Study Locations
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