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Completed

NCT Number: NCT04200482

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

One Diet and Physical Activity Session

Behavioral

Attend 1 remote diet and physical activity session

Other names: Behavior or Lifestyle Modifications, behavior modification, Behavior Conditioning Therapy, Behavioral Interventions, Behavioral Treatments

Electronic (e) Health (eHealth) Communication Intervention

Other

Receive eHealth communication intervention

Twelve Diet and Physical Activity Group Sessions

Behavioral

Attend 12 remote diet and physical activity sessions in 6 months

Other names: Behavior or Lifestyle Modifications, behavior modification, Behavior Conditioning Therapy, Behavioral Interventions, Behavioral Treatments

Questionnaire Administration

Other

Ancillary studies

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Primary outcomes

  1. Accrual rate

    Time frame: At 6 months

    Accrual rate will be measured by number of participants randomized during each month of study accrual.

  2. Adherence: Session(s) Attendance

    Time frame: At 6 months

    Adherence will be measured by number of online session(s) attended per participant.

  3. Adherence: Responsiveness to eHealth communication

    Time frame: At 6 months

    Adherence will be measured by the number of responses to text messages per participant.

  4. Biospecimen collection rate

    Time frame: At 6 months

    Biospecimen collection rate will be assessed based on number of biospecimens collected.

  5. Retention

    Time frame: At 6 months

    Retention will be measured by the number of completed study assessments per participants.

  6. Acceptability: Questions during exit interview

    Time frame: At 6 months

    Acceptability will be measured by questions asking about trial acceptability in the exit questionnaire.

Secondary outcomes

  1. Change in daily servings of fruits and vegetables per day

    Time frame: Baseline to 6 months

    Will be assessed by 24-hour dietary recalls.

  2. 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.

  3. Change in systemic inflammation

    Time frame: Baseline to 6 months

    Will be assessed by fasting blood concentrations of high sensitivity C-reactive protein.

  4. 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.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • Breast Cancer Research Foundation

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 16, 2019
Registry last updated
Nov 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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