Taking Charge during Treatment (TCT) Intervention for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast CancerTaking Charge during Treatment (TCT) Intervention - Behavioral
Eligibility
18 - 100
Female
What conditions do you have?
Select

Study Summary

This trial is looking at how cancer drugs impact the vascular system and whether or not exercise can help offset some of those changes.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: T1 (baseline), T2 (18-24 weeks), and T3 (12 months)

Month 12
6 Minute Walk Test
Accelerometry
Assess mitochondrial DNA damage
Cardiac function - Echocardiagram
Cardiac function - Pulse Wave Velocity
Cognitive Function
Cytokine analysis
DEXA Scan
Endothelial function
Flow Mediated Dilation
Functional Assessment of Cancer Therapy - General (FACT-B)
Gene Express Profiling
Handgrip strength
Height and Weight
Hospital Anxiety and Depression Scale
Maximal Exercise: Maximal oxygen consumption will be evaluated using cycle ergometry or treadmill to exhaustion as described in the Integrative Physiology Laboratory at each testing visit.
PROMIS - Pain Interference
PROMIS - Social Support
Perceived Stress Scale
Physical Activity self report
Pittsburgh Sleep Quality Index
Sit to Stand
Sitting Time Questionnaire
Thermometer, device
The Functional Assessment of Chronic Illness Therapy - Fatigue

Trial Safety

Trial Design

2 Treatment Groups

Taking Charge during Treatment (TCT) Intervention
1 of 2
Control Group
1 of 2

Active Control

80 Total Participants · 2 Treatment Groups

Primary Treatment: Taking Charge during Treatment (TCT) Intervention · No Placebo Group · N/A

Taking Charge during Treatment (TCT) Intervention
Behavioral
ActiveComparator Group · 1 Intervention: Taking Charge during Treatment (TCT) Intervention · Intervention Types: Behavioral
Control GroupNoIntervention Group · 1 Intervention: Control Group · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: t1 (baseline), t2 (18-24 weeks), and t3 (12 months)

Who is running the clinical trial?

University of Illinois at ChicagoOTHER
539 Previous Clinical Trials
1,551,307 Total Patients Enrolled
7 Trials studying Breast Cancer
1,341,703 Patients Enrolled for Breast Cancer
Medical College of WisconsinLead Sponsor
566 Previous Clinical Trials
1,154,038 Total Patients Enrolled
9 Trials studying Breast Cancer
406,993 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18 - 100 · Female Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been assigned female at birth.
You are able to safely participate in moderate exercise and strength training based on MD approval.
You are Black/African American or non-Hispanic White.