Improving Communication and Adherence in Black Breast Cancer Survivors (Sisters Informing Sisters)
SIS
2 other identifiers
interventional
250
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Mar 2021
Longer than P75 for not_applicable breast-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2021
CompletedFirst Submitted
Initial submission to the registry
April 12, 2022
CompletedFirst Posted
Study publicly available on registry
April 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
April 8, 2026
April 1, 2026
6 years
April 12, 2022
April 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Assessing Study Adherence Behaviors- Initiation
Initiation will be measured for all therapies based on the number of participants starting at least one cycle of prescribed therapy
36 Months
Assessing Study Adherence Behaviors- Delay of Adjuvant or Endocrine Therapy.
Initiation Delay of therapy will be measured by the number of participant's days from definitive surgery date to the date of her first cycle of adjuvant systemic therapy. Classifications of delay are dichotomized according to published reports (\<60 days primary measure).
36 Months
Assessing Study Adherence Behaviors- Overall Chemotherapy Adherence
Overall chemotherapy adherence will be measured by the number of participants that complete chemotherapy. Chemotherapy adherence will be measured as having at least 80% or more of the recommended doses. Adherence will be calculated based on the planned and expected number of cycles divided by the number received (i.e., 6 chemotherapy cycles received/8 expected = 75% adherent).
36 Months
Secondary Outcomes (6)
Assess Perceived Involvement in Care: PCC Outcomes - Level of Engagement in Decision Making
36 Months
Assess Perceived Involvement in Care: PCC Outcomes - Perceptions of Doctor Behaviors by determining a more patient-centered encounter vs a more biomedically focused encounter.
36 Months
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
36 Months
Determine Process and Implementation Outcomes
36 Months
Determine Process and Implementation Outcomes
36 Months
- +1 more secondary outcomes
Study Arms (2)
Sisters Informing Sisters Sessions
EXPERIMENTALThe 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.
Enhanced Usual Care
NO INTERVENTIONWomen 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.
Interventions
The participants in this arm will be seen by a trained survivor coach and receive culturally tailored intervention materials.
Eligibility Criteria
You may qualify if:
- Self-identify as Black
- Newly diagnosed (\~4 weeks post-definitive surgery and prior to initiation of adjuvant chemotherapy or endocrine therapy) patients (stage I-III)
- Eligible for chemotherapy or endocrine therapy according to NCCN guidelines, but have not initiated systemic therapy
- Ability to read and speak English
- Ability to provide meaningful consent as determined by trained study personnel and/or a member of the patient's care team
- No prior cancer treatment (other than skin cancer) in the two years preceding enrollment
- Physicians Must be a license doctor of study patient(s)
- Ability to speak English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Virginia Commonwealth Universitylead
- Georgetown Universitycollaborator
Study Sites (3)
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Massey Cancer Center
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vanessa B Sheppard, Ph.D
Virginia Commonwealth University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2022
First Posted
April 19, 2022
Study Start
March 1, 2021
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
February 28, 2027
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
There is no plan to make IPD available.