Breast CancerSISNCT05334732
Improving Communication and Adherence in Black Breast Cancer Survivors (Sisters Informing Sisters)
A study testing SIS TALK Back Intervention in people with Breast Cancer, run by Virginia Commonwealth University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SIS TALK Back Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Mar 2021to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massey Cancer Center
Richmond, Virginia, 23298
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Improving Communication and Adherence in Black Breast Cancer Survivors
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.
Read the detailed description
Black women continue to experience worse breast cancer outcomes, which may be due to inadequate adherence to systemic therapies that can be improved via patient-centered communication. We developed and piloted the Sisters Informing SistersSM (SIS) intervention (survivor-led skill-building sessions and culturally tailored materials to activate Black breast cancer survivors in their medical encounters) and obtained promising findings. This project will compare in a two-arm RCT the impact of SIS vs. enhanced usual care (treatment recommendation summary form) on patient-centered communication and systemic treatment adherence; SIS tools may be integrated within existing clinical and support services.
- Conditions
- Breast Cancer
- Being tested
- SIS TALK Back Intervention
- Keywords
- Breast Cancer, Black Women, Breast Cancer Survivor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIS TALK Back InterventionBehavioural
The participants in this arm will be seen by a trained survivor coach and receive culturally tailored intervention materials.
| Study group | Role | What they receive |
|---|---|---|
| Sisters Informing Sisters Sessions | Experimental | 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. Receives: Behavioral: SIS TALK Back Intervention |
| Enhanced Usual Care | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 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).
Measured: 36 Months
Secondary outcomes (6)
Assess Perceived Involvement in Care: PCC Outcomes - Level of Engagement in Decision Making
The number of participants level of engagement in decision-making will be assessed by utilizing The Perceived Involvement in Care (PCC) 13-Item scale. PCC will be assessed via direct observation of medical encounters through a quantitative analysis of audiotaped visits.
Measured: 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.
The number of participants level of engagement in perceptions of doctor behaviors will be assessed by utilizing The Perceived Involvement in Care (PCC) 13-Item scale. PCC will be assessed via direct observation of medical encounters through a quantitative analysis of audiotaped visits. A value >1 indicates a more patient-centered encounter, whereas a value <1 indicates a more biomedically focused encounter.
Measured: 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
The number of participants level of engagement in perceptions of patient behaviors will be assessed by utilizing The Perceived Involvement in Care (PCC) 13-Item scale. PCC will be assessed via direct observation of medical encounters through a quantitative analysis of audiotaped visits. A value >1 indicates a more patient-centered encounter, whereas a value <1 indicates a more biomedically focused encounter.
Measured: 36 Months
Determine Process and Implementation Outcomes
Assess the number of participants who Consent to Participate in the trial
Measured: 36 Months
Determine Process and Implementation Outcomes
Assess the number of participants that participate in the trial after they sign consent
Measured: 36 Months
Determine Process and Implementation Outcomes
Assess the Cost of the trial per arm. Personnel time costs will be obtained by multiplying the staff time. costs by hourly average wage and fringe benefit rates. The staff time will include the training to identify at-risk women and the time spent administering/reviewing study materials including the treatment summary request form
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Mar 2021
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgetown University
- Responsible party
- Sponsor
- Investigators
- Vanessa B Sheppard, Ph.D, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334732
- Sponsor's protocol ID
- MCC-19-15740
- Other IDs
- HM20016396
- Acronym
- SIS
- Status last verified
- Aug 2026
- First submitted
- 12 Apr 2022
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Communication and Adherence in Black Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05334732
- Acronym / sponsor ID
- SIS / MCC-19-15740
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Black Women, Breast Cancer Survivor
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Georgetown University
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Black women continue to experience worse breast cancer outcomes, which may be due to inadequate adherence to systemic therapies that can be improved via patient-centered communication. We developed and piloted the Sisters Informing SistersSM (SIS) intervention (survivor-led skill-building sessions and culturally tailored materials to activate Black breast cancer survivors in their medical encounters) and obtained promising findings. This project will compare in a two-arm RCT the impact of SIS vs. enhanced usual care (treatment recommendation summary form) on patient-centered communication and systemic treatment adherence; SIS tools may be integrated within existing clinical and support services.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sisters Informing Sisters Sessions | Experimental | Behavioral: SIS TALK Back InterventionThe 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 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIS TALK Back InterventionThe participants in this arm will be seen by a trained survivor coach and receive culturally tailored intervention materials. | Behavioural | Sisters Informing Sisters Sessions |
Primary outcome
Assessing Study Adherence Behaviors- Initiation
Time frame: 36 Months
Initiation will be measured for all therapies based on the number of participants starting at least one cycle of prescribed therapy
Assessing Study Adherence Behaviors- Delay of Adjuvant or Endocrine Therapy.
Time frame: 36 Months
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).
Assessing Study Adherence Behaviors- Overall Chemotherapy Adherence
Time frame: 36 Months
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).
6 secondary outcomes
Assess Perceived Involvement in Care: PCC Outcomes - Level of Engagement in Decision Making
Time frame: 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.
Time frame: 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
Time frame: 36 Months
Determine Process and Implementation Outcomes
Time frame: 36 Months
Determine Process and Implementation Outcomes
Time frame: 36 Months
Determine Process and Implementation Outcomes
Time frame: 36 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No. There is no plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa B Sheppard, Ph.D principal investigator
Virginia Commonwealth University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIS TALK Back Intervention in people with Breast Cancer, run by Virginia Commonwealth University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing Study Adherence Behaviors- Initiation (time frame: 36 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.