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

November 2, 2021 updated by: Fred Hutchinson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Behavioral: One Diet and Physical Activity Session
Attend 1 remote diet and physical activity session
Other Names:
  • Behavior Conditioning Therapy
  • Behavioral Interventions
  • Behavioral Treatments
  • behavior modification
  • Behavior or Lifestyle Modifications
Other: Electronic (e) Health (eHealth) Communication Intervention
Receive eHealth communication intervention
Experimental: 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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
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 Names:
  • Behavior Conditioning Therapy
  • Behavioral Interventions
  • Behavioral Treatments
  • behavior modification
  • Behavior or Lifestyle Modifications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accrual rate
Time Frame: At 6 months
Accrual rate will be measured by number of participants randomized during each month of study accrual.
At 6 months
Adherence: Session(s) Attendance
Time Frame: At 6 months
Adherence will be measured by number of online session(s) attended per participant.
At 6 months
Adherence: Responsiveness to eHealth communication
Time Frame: At 6 months
Adherence will be measured by the number of responses to text messages per participant.
At 6 months
Biospecimen collection rate
Time Frame: At 6 months
Biospecimen collection rate will be assessed based on number of biospecimens collected.
At 6 months
Retention
Time Frame: At 6 months
Retention will be measured by the number of completed study assessments per participants.
At 6 months
Acceptability: Questions during exit interview
Time Frame: At 6 months
Acceptability will be measured by questions asking about trial acceptability in the exit questionnaire.
At 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in daily servings of fruits and vegetables per day
Time Frame: Baseline to 6 months
Will be assessed by 24-hour dietary recalls.
Baseline to 6 months
Change in minutes per week of moderate-to-vigorous physical activity
Time Frame: Baseline to 6 months
Will be assessed by 7-day accelerometer data.
Baseline to 6 months
Change in systemic inflammation
Time Frame: Baseline to 6 months
Will be assessed by fasting blood concentrations of high sensitivity C-reactive protein.
Baseline to 6 months
Change in gut barrier permeability
Time Frame: Baseline to 6 months
Will be assessed by fasting circulating levels of gut bacterial endotoxin liposaccharide-binding protein.
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

Breast Cancer Research Foundation

Investigators

  • Principal Investigator: Nancy E Davidson, Fred Hutch/University of Washington Cancer Consortium
  • Principal Investigator: Heather Greenlee, Fred Hutch/University of Washington Cancer Consortium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2020

Primary Completion (Actual)

August 24, 2021

Study Completion (Actual)

October 28, 2021

Study Registration Dates

First Submitted

December 10, 2019

First Submitted That Met QC Criteria

December 12, 2019

First Posted (Actual)

December 16, 2019

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

November 2, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG1006427
  • 10335 (Other Identifier: CTEP)
  • NCI-2019-07643 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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