← Back to Search

Communication and Adherence Intervention for Breast Cancer (SIS Trial)

N/A

Recruiting

Led By Vanessa B Sheppard, Ph.D

Research Sponsored by Virginia Commonwealth University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No prior cancer treatment (other than skin cancer) in the two years preceding enrollment

Eligible for chemotherapy or endocrine therapy according to NCCN guidelines, but have not initiated systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new way to help Black women stick to their systemic therapy, which is the main treatment for breast cancer.

Who is the study for?

This trial is for Black women who have been recently diagnosed with breast cancer (stage I-III), haven't started systemic therapy like chemotherapy or endocrine therapy, and haven't had any other cancer treatments in the last two years. Participants must be able to speak and read English, provide consent, and their doctors need to be licensed.

What is being tested?

The study is testing an intervention called 'SIS TALK Back' aimed at improving adherence to systemic therapies among Black breast cancer survivors. It will compare this new approach against what's normally done in these cases.

What are the potential side effects?

Since this trial focuses on communication strategies rather than medical treatments, there are no direct side effects from drugs or procedures. However, participants may experience emotional or psychological impacts related to discussing their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I haven't had cancer treatment in the last 2 years, except for skin cancer.

Select...

I am eligible for, but have not started, chemotherapy or hormone therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessing Study Adherence Behaviors- Delay of Adjuvant or Endocrine Therapy.

Assessing Study Adherence Behaviors- Initiation

Assessing Study Adherence Behaviors- Overall Chemotherapy Adherence

Secondary study objectives

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

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sisters Informing Sisters SessionsExperimental Treatment1 Intervention

The intervention is peer-based and in concert with our theoretical model, builds upon positive role-modeling of the survivor coach to the patient, addresses behavioral expectations/capacities, and uses Motivational Interviewing (MI) techniques. The intervention includes a culturally relevant coach's manual and a patient workbook that will be used to facilitate the coaching sessions.

Group II: Enhanced Usual CareActive Control1 Intervention

Women in the EUC arm will receive usual care that includes standardized information in the public domain (NCI treatment information booklet). This booklet was chosen to provide women with national-level recommendations regarding treatment recommendations.

0 / 2Eligibility criteria met