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

NCT03523195 | Completed

• 3 other identifiers: 9988NCI-2018-00544P30CA015704
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Adherence

  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

  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 Outcomes (1)

• 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

  Up to 26 weeks

Study Arms (2)

Arm 0 (written information)

ACTIVE COMPARATOR

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

Other: Informational Intervention; Other: Laboratory Biomarker Analysis; Device: Monitoring Device; Other: Questionnaire Administration; Other: Physical Performance Testing

Arm I (exercise program)

EXPERIMENTAL

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.

Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Other: Physical Performance Testing

Interventions

Exercise Intervention BEHAVIORAL

Complete exercise program

Arm I (exercise program)

Informational Intervention OTHER

Receive written information on healthy exercise and diet recommendations

Arm 0 (written information)

Laboratory Biomarker Analysis OTHER

Blood tests

Arm 0 (written information); Arm I (exercise program)

Monitoring Device DEVICE

Wear Fitbit

Also known as: Monitor

Arm 0 (written information)

Questionnaire Administration OTHER

Ancillary studies

Arm 0 (written information); Arm I (exercise program)

Physical Performance Testing OTHER

Performance of physical tests

Also known as: Physical Function Testing

Arm 0 (written information); Arm I (exercise program)

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Monitoring, Physiologic; Exercise Test

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Karen Syrjala

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

• Julie Gralow

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

• Marie-Laure Crouch

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 14, 2018
• Study Start: April 18, 2018
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2019
• Last Updated: July 22, 2019

Record last verified: 2019-07

Locations

US (1)