SIS TALK Back Intervention for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Massey Cancer Center, Richmond, VA
Breast Cancer+1 More
SIS TALK Back Intervention - Behavioral
Eligibility
18+
Female
What conditions do you have?
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Study Summary

The purpose of this study is to test an evidence-based intervention designed to increase adherence to systemic therapy in Black women compared to enhanced usual care.

Eligible Conditions

  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: 36 Months

36 Months
Assess Perceived Involvement in Care: PCC Outcomes - Level of Engagement in Decision Making
Assess Perceived Involvement in Care: PCC Outcomes - Perceptions of Doctor Behaviors by determining a more patient-centered encounter vs a more biomedically focused encounter.
Assess Perceived Involvement in Care: PCC Outcomes - Perceptions of Patient Behaviors by determining Perceptions of Doctor Behaviors by determining a more patient-centered encounter vs a more biomedically focused encounter
Assessing Study Adherence Behaviors- Delay of Adjuvant or Endocrine Therapy.
Assessing Study Adherence Behaviors- Initiation
Assessing Study Adherence Behaviors- Overall Chemotherapy Adherence
Determine Process and Implementation Outcomes

Trial Safety

Trial Design

2 Treatment Groups

Enhanced Usual Care
1 of 2
Sisters Informing Sisters Sessions
1 of 2
Active Control
Experimental Treatment

460 Total Participants · 2 Treatment Groups

Primary Treatment: SIS TALK Back Intervention · No Placebo Group · N/A

Sisters Informing Sisters Sessions
Behavioral
Experimental Group · 1 Intervention: SIS TALK Back Intervention · Intervention Types: Behavioral
Enhanced Usual CareNoIntervention Group · 1 Intervention: Enhanced Usual Care · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months
Closest Location: Massey Cancer Center · Richmond, VA
Photo of Richmond 1Photo of Richmond 2Photo of Richmond 3
2009First Recorded Clinical Trial
8 TrialsResearching Breast Cancer
63 CompletedClinical Trials

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
609 Previous Clinical Trials
341,925 Total Patients Enrolled
17 Trials studying Breast Cancer
1,922 Patients Enrolled for Breast Cancer
Georgetown UniversityOTHER
315 Previous Clinical Trials
120,365 Total Patients Enrolled
33 Trials studying Breast Cancer
12,910 Patients Enrolled for Breast Cancer
Vanessa B Sheppard, Ph.DPrincipal InvestigatorVirginia Commonwealth University

Eligibility Criteria

Age 18+ · Female Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are eligible for chemotherapy or endocrine therapy according to NCCN guidelines, but have not initiated systemic therapy.
You are able to provide meaningful consent as determined by trained study personnel and/or a member of the patient's care team.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.