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

Primary Purpose

Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise Intervention

Informational Intervention

Laboratory Biomarker Analysis

Monitoring Device

Questionnaire Administration

Physical Performance Testing

About this trial

This is an interventional supportive care trial for Anatomic Stage II Breast Cancer AJCC v8

Eligibility Criteria

19 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm 0 (written information)

Arm I (exercise program)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Adherence

Will assess the percent of expected onsite sessions attended by participants as determined by Prevention Center attendance log.

Differential micro ribonucleic acid expression

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03523195

First Posted

May 1, 2018

Last Updated

July 19, 2019

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03523195

Brief Title

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

Acronym

PACT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

April 18, 2018 (Actual)

Primary Completion Date

July 15, 2019 (Actual)

Study Completion Date

July 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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, Cancer Survivor, Estrogen Receptor Positive, HER2/Neu Negative, Progesterone Receptor Positive, 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, Sedentary Lifestyle

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 0 (written information)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm I (exercise program)

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Exercise Intervention

Intervention Description

Complete exercise program

Intervention Type

Other

Intervention Name(s)

Informational Intervention

Intervention Description

Receive written information on healthy exercise and diet recommendations

Intervention Type

Other

Intervention Name(s)

Laboratory Biomarker Analysis

Intervention Description

Blood tests

Intervention Type

Device

Intervention Name(s)

Monitoring Device

Other Intervention Name(s)

Monitor

Intervention Description

Wear Fitbit

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

Physical Performance Testing

Other Intervention Name(s)

Physical Function Testing

Intervention Description

Performance of physical tests

Primary Outcome Measure Information:

Title

Adherence

Description

Will assess the percent of expected onsite sessions attended by participants as determined by Prevention Center attendance log.

Time Frame

Up to 26 weeks

Title

Differential micro ribonucleic acid expression

Description

Time Frame

At baseline, 13, and 26 weeks

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen Syrjala

Organizational Affiliation

Fred Hutch/University of Washington Cancer Consortium

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Julie Gralow

Organizational Affiliation

Fred Hutch/University of Washington Cancer Consortium

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marie-Laure Crouch

Organizational Affiliation

Fred Hutch/University of Washington Cancer Consortium

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fred Hutch/University of Washington Cancer Consortium

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

12. IPD Sharing Statement

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

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