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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fred Hutchinson Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Breast Cancer Research Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 24, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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