Lifestyle Program (Scalable Nutrition and Physical Activity) for the Improvement of Nutrition and Physical Activity in Stage 0-III Breast Cancer Survivors

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

Official title:

Testing a Scalable Nutrition and Physical Activity Program for Breast Cancer Survivors: A Dose-Finding Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04200482
• Other study ID #: RG1006427
• Secondary ID: NCI-2019-0764310
• Status: Completed
• Phase: Phase 2
• Start date: February 21, 2020
• Est. completion date: October 28, 2021

Study information

• Verified date: November 2021
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 28, 2021
• Est. primary completion date: August 24, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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
• Breast Carcinoma In Situ
• Breast Neoplasms
• 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

Intervention

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
• Quality-of-Life Assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	Breast Cancer Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accrual rate	Accrual rate will be measured by number of participants randomized during each month of study accrual.	At 6 months
Primary	Adherence: Session(s) Attendance	Adherence will be measured by number of online session(s) attended per participant.	At 6 months
Primary	Adherence: Responsiveness to eHealth communication	Adherence will be measured by the number of responses to text messages per participant.	At 6 months
Primary	Biospecimen collection rate	Biospecimen collection rate will be assessed based on number of biospecimens collected.	At 6 months
Primary	Retention	Retention will be measured by the number of completed study assessments per participants.	At 6 months
Primary	Acceptability: Questions during exit interview	Acceptability will be measured by questions asking about trial acceptability in the exit questionnaire.	At 6 months
Secondary	Change in daily servings of fruits and vegetables per day	Will be assessed by 24-hour dietary recalls.	Baseline to 6 months
Secondary	Change in minutes per week of moderate-to-vigorous physical activity	Will be assessed by 7-day accelerometer data.	Baseline to 6 months
Secondary	Change in systemic inflammation	Will be assessed by fasting blood concentrations of high sensitivity C-reactive protein.	Baseline to 6 months
Secondary	Change in gut barrier permeability	Will be assessed by fasting circulating levels of gut bacterial endotoxin liposaccharide-binding protein.	Baseline to 6 months