Clinical trial NCT04200482: Lifestyle Program (Scalable Nutrition and Physical Activity) for the Improvement of Nutrition and Physical Activity in Stage 0-III Breast Cancer Survivors
Official title: Testing a Scalable Nutrition and Physical Activity Program for Breast Cancer Survivors: A Dose-Finding Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Keywords: Breast Cancer Survivors
Diet
eHealth
Nutrition
Physical Activity
Breast
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
First posted: 2019-12-16
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: OUTLINE: Participants are randomized to 1 of 2 arms.

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.

Eligibility criteria: Inclusion Criteria:

* Previous diagnosis of stage 0-III breast cancer in the past 10 years at the time of enrollment
* 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:

* Participants must not be active smokers within the past 30 days.
* Women must not be pregnant at time of enrollment

Primary outcomes:
measure: Accrual rate
timeFrame: At 6 months
measure: Adherence: Session(s) Attendance
timeFrame: At 6 months
measure: Adherence: Responsiveness to eHealth communication
timeFrame: At 6 months
measure: Biospecimen collection rate
timeFrame: At 6 months
measure: Retention
timeFrame: At 6 months
measure: Acceptability: Questions during exit interview
timeFrame: At 6 months
Secondary outcomes:
measure: Change in daily servings of fruits and vegetables per day
timeFrame: Baseline to 6 months
measure: Change in minutes per week of moderate-to-vigorous physical activity
timeFrame: Baseline to 6 months
measure: Change in systemic inflammation
timeFrame: Baseline to 6 months
measure: Change in gut barrier permeability
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Nancy E Davidson
role: PRINCIPAL_INVESTIGATOR
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Heather Greenlee
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.