Lifestyle Program (Scalable Nutrition and Physical Activity) for the Improvement of Nutrition and Physical Activity in Stage 0-III Breast Cancer Survivors
NCT ID: NCT04200482
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2020-02-21
2021-10-28
Brief Summary
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Detailed Description
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ARM A (LOW DOSE): Participants attend one diet and physical activity class delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
ARM B (HIGH DOSE): Participants attend 12 twice monthly diet and physical activity online sessions delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm A (low dose nutrition and PA class, eHealth intervention)
Participants attend one diet and physical activity class delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
One Diet and Physical Activity Session
Attend 1 remote diet and physical activity session
Electronic (e) Health (eHealth) Communication Intervention
Receive eHealth communication intervention
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Arm B (high dose nutrition and PA class, eHealth intervention)
Participants attend 12 twice monthly diet and physical activity online sessions delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
Electronic (e) Health (eHealth) Communication Intervention
Receive eHealth communication intervention
Twelve Diet and Physical Activity Group Sessions
Attend 12 remote diet and physical activity sessions in 6 months
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Interventions
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One Diet and Physical Activity Session
Attend 1 remote diet and physical activity session
Electronic (e) Health (eHealth) Communication Intervention
Receive eHealth communication intervention
Twelve Diet and Physical Activity Group Sessions
Attend 12 remote diet and physical activity sessions in 6 months
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No evidence of recurrent or metastatic disease
* No uncontrolled diabetes mellitus defined as glycosylated hemoglobin (Hgb A1C) \> 8%
* No uncontrolled hypertension per Seattle Cancer Care Alliance (SCCA) standard of care
* At least 60 days post final chemotherapy, biologic therapy, or radiation therapy and/or surgery. Current use of endocrine therapy is permitted (e.g., tamoxifen and aromatase inhibitors)
* Access to phone for study contacts
* Access to smartphone, tablet, or computer and internet to attend online session(s) and receive study electronic eHealth communication (text messages and access to website)
* Willing and able to attend the online session(s) on Saturdays, or via online accessed videos, for up to 12 sessions in 6 months
* Successfully complete all run-in activities, including at-home and over the phone assessments, 7 days of collecting physical activity data via accelerometer, and providing blood and stool sample
* Willing and able to complete all study activities for 6 months after randomization
* Participants must consume \< 5 servings of fruits and vegetables per day and/or engage in \< 150 minutes per week of moderate to vigorous physical activity, as assessed by brief questionnaires
* Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of performance status score of 0 or 1 for performance status.
* Signed physician approval for diet change and physical activity
* Able to understand and willing to sign written informed electronic (e) consent in English
Exclusion Criteria
* Women must not be pregnant at time of enrollment
18 Years
FEMALE
No
Sponsors
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Breast Cancer Research Foundation
OTHER
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Nancy E Davidson
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Heather Greenlee
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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References
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Ueland K, Sanchez SC, Rillamas-Sun E, Shen H, Schattenkerk L, Garcia G, VanDoren M, Myers SA, Santiago-Torres M, Di C, Dey N, Guthrie KA, Yung R, Davidson NE, Greenlee H. A digital health intervention to improve nutrition and physical activity in breast cancer survivors: Rationale and design of the Cook and Move for Your Life pilot and feasibility randomized controlled trial. Contemp Clin Trials. 2022 Dec;123:106993. doi: 10.1016/j.cct.2022.106993. Epub 2022 Nov 3.
Rillamas-Sun E, Schattenkerk L, Cobos S, Ueland K, Gaffney AO, Greenlee H. Characteristics of Users of the Cook for Your Life Website, an Online Nutrition Resource for Persons Affected by Cancer: Descriptive Study. JMIR Cancer. 2022 Jul 5;8(3):e37212. doi: 10.2196/37212.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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NCI-2019-07643
Identifier Type: REGISTRY
Identifier Source: secondary_id
10335
Identifier Type: OTHER
Identifier Source: secondary_id
RG1006427
Identifier Type: -
Identifier Source: org_study_id