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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

SIS Trial 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.Check my eligibility

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.See study design

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.

SIS Trial Eligibility Criteria

Inclusion Criteria

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

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

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

SIS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Assessing Study Adherence Behaviors- Initiation

Assessing Study Adherence Behaviors- Overall Chemotherapy Adherence

Secondary outcome measures

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

SIS 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

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor

699 Previous Clinical Trials

22,884,585 Total Patients Enrolled

18 Trials studying Breast Cancer

1,984 Patients Enrolled for Breast Cancer

Georgetown UniversityOTHER

343 Previous Clinical Trials

136,042 Total Patients Enrolled

33 Trials studying Breast Cancer

12,625 Patients Enrolled for Breast Cancer

Vanessa B Sheppard, Ph.DPrincipal InvestigatorVirginia Commonwealth University

Media Library

SIS TALK Back Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05334732 — N/A

Breast Cancer Research Study Groups: Sisters Informing Sisters Sessions, Enhanced Usual Care

Breast Cancer Clinical Trial 2023: SIS TALK Back Intervention Highlights & Side Effects. Trial Name: NCT05334732 — N/A

SIS TALK Back Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05334732 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for enrolling participants in this trial?

"Affirmative. Clinicaltrials.gov documents that, following its initial posting on March 1st 2021 and most recent review April 20th 2022, this clinical trial is currently recruiting participants - with 460 people needed from two distinct locations."

Answered by AI

How many participants are participating in this medical trial at the present time?

"That is correct. According to records posted on clinicaltrials.gov, this medical trial was initially launched in March 2021 and last modified in April 2022. 460 participants must be recruited from two different research sites for the study to continue its progress."

Answered by AI

What aim is this experiment seeking to fulfill?

"This study, taking place over 36 months, aims to evaluate participants' adherence behaviors as they start the trial. Secondary objectives include measuring patient and doctor engagement via a Perceived Involvement in Care (PCC) 13-Item scale during audiotaped medical encounters. This assessment will be used to differentiate between more biomedically focused versus patient-centered care."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Communication and Adherence in Black Breast Cancer Survivors (Sisters Informing Sisters)

2021. "Improving Communication and Adherence in Black Breast Cancer Survivors (Sisters Informing Sisters)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05334732.