Exercise Intervention After Cancer Treatment for Improving Health in Stage II-III Breast Cancer Survivors (PACT)

July 19, 2019 updated by: Fred Hutchinson Cancer Center

Physical Activity After Cancer Treatment (PACT): Pilot Study of Exercise in Stage II-III Breast Cancer Survivors

This pilot trial studies how well exercise intervention after cancer treatment works in improving physical activity in stage II-III breast cancer survivors. An exercise intervention may promote regular physical activity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Estimate the adherence rate of the experimental exercise program, and deem as feasible if at least 80% of participants complete 80% or more of a 12-week, 180 minute aerobic+resistance training program that combines structured, individualized onsite exercise at the Fred Hutch Prevention Center with at-home exercise.

II. Identify up to 5 circulating micro ribonucleic acid (c-miRNA) biomarkers that show the largest differential change from baseline when comparing levels in the exercise program to those in the Fitbit-activity control condition.

SECONDARY OBJECTIVES:

I. Explore associations between changes in miRNAs and serum biomarkers (IL-6, lipids, adiponectin and leptin, C-reactive protein [CRP]) and physiological outcomes (resting heart rate, blood pressure, 1 repetition max, 6 minute walk, timed up and go test) of the exercise program.

II. Explore changes in the patient-reported outcomes (PRO) in response to the exercise intervention relative to the control group, and finalize measures to use in the design of the phase III clinical trial based on descriptive changes from baseline to follow-ups in the intervention versus (vs.) control groups.

OUTLINE: Participants are randomized into 1 of 2 arms.

ARM 0: Participants wear Fitbit and receive written information on healthy exercise and diet recommendations.

ARM 1: Participants complete exercise program including aerobic and resistance exercises over 60 minutes 3 times per week for 12 weeks. Exercise is supervised all 3 times during weeks 1-2. During weeks 3-12, exercise is supervised 2 times a week, with home-based coaching for an additional 60 minutes a week.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

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

19 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Single malignancy with diagnosis of breast cancer diagnosis of stage II-III, estrogen and progesterone positive, HER-2neu negative, and on stable dose of aromatase inhibitor (AI) for past 3 months, with AI expected to be stable for the study duration
  • No evidence of disease
  • 1-5 years post active treatment for malignancy
  • Body mass index 19 to 35
  • Sedentary (< 100 minutes of moderate intensity exercise per week)
  • English adequate to complete assessments and follow exercise instructions
  • Able to independently use transportation to attend 2-day a week onsite exercise training
  • Access to a computer or smartphone

Exclusion Criteria:

  • Current tobacco use or electronic cigarette smoker
  • Pregnant
  • Diabetes requiring insulin injection
  • Lymphedema that restricts range of motion or with worsening symptoms in the past month, or without compression garment
  • Weight change of more than 10 pounds in previous 3 months will exclude from study participation at baseline

  • Medical or other issue impacting exercise ability or safety, or ability to comply with study procedures (e.g. significant vision or cognitive impairment, major illness, in hospital or other institution), and specifically:

    • Have been hospitalized within 3 months prior to screening for major atherosclerotic events (e.g. myocardial infarction, target-vessel revascularization, coronary bypass surgery, stroke or blood clot) or other major medical condition (as determined by an investigator) that may put the subject at risk because of his/her participation in the study;
    • Have an implanted cardiac pacemaker or other implanted cardiac device;
    • Have chronic, uncontrolled hypertension as judged by the investigator;
    • Have a creatinine clearance < 45 mL/min as calculated by the Cockcroft-Gault equation;
    • Subject's hand or legs have mobility impairment from fractures, arthritis, surgery, muscle disease or other injury that may interfere with any study procedure or ability to exercise

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Arm 0 (written information)
Participants wear Fitbit and receive written information on healthy exercise and diet recommendations.
Other: Questionnaire Administration
Ancillary studies
Device: Monitoring Device
Wear Fitbit
Other Names:
  • Monitor
Other: Informational Intervention
Receive written information on healthy exercise and diet recommendations
Other: Laboratory Biomarker Analysis
Blood tests
Other: Physical Performance Testing
Performance of physical tests
Other Names:
  • Physical Function Testing
EXPERIMENTAL: Arm I (exercise program)
Participants complete exercise program including aerobic and resistance exercises over 60 minutes 3 times per week for 12 weeks. Exercise is supervised all 3 times during weeks 1-2. During weeks 3-12, exercise is supervised 2 times a week, with home-based coaching for an additional 60 minutes a week.
Other: Questionnaire Administration
Ancillary studies
Behavioral: Exercise Intervention
Complete exercise program
Other: Laboratory Biomarker Analysis
Blood tests
Other: Physical Performance Testing
Performance of physical tests
Other Names:
  • Physical Function Testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: Up to 26 weeks
Will assess the percent of expected onsite sessions attended by participants as determined by Prevention Center attendance log.
Up to 26 weeks
Differential micro ribonucleic acid expression
Time Frame: At baseline, 13, and 26 weeks
Will compare between arms. Descriptive statistics will be provided. Will calculate the log-fold change between baseline measure and post-baseline measure, and the difference in the log-fold change will be calculated between the two arms.
At baseline, 13, and 26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent of expected home exercise sessions completed as determined by the home exercise logs for those choosing to not come in for a third weekly session
Time Frame: Up to 26 weeks
Up to 26 weeks

Collaborators and Investigators

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

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Julie Gralow, Fred Hutch/University of Washington Cancer Consortium
  • Principal Investigator: Marie-Laure Crouch, Fred Hutch/University of Washington Cancer Consortium

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)

April 18, 2018

Primary Completion (ACTUAL)

July 15, 2019

Study Completion (ACTUAL)

July 15, 2019

Study Registration Dates

First Submitted

May 1, 2018

First Submitted That Met QC Criteria

May 1, 2018

First Posted (ACTUAL)

May 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 22, 2019

Last Update Submitted That Met QC Criteria

July 19, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9988 (OTHER: Fred Hutch/University of Washington Cancer Consortium)
  • P30CA015704 (U.S. NIH Grant/Contract)
  • NCI-2018-00544 (REGISTRY: CTRP (Clinical Trial Reporting Program))

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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