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

Breast Cancer Clinical Trial

— SIS  

Official title:

Improving Communication and Adherence in Black Breast Cancer Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05334732
• Other study ID #: MCC-19-15740
• Secondary ID: HM20016396
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: January 31, 2025

Study information

• Verified date: May 2024
• Source: Virginia Commonwealth University
• Contact: Vanessa B Sheppard, Ph.D
• Phone: 804-682-2700
• Email: vanessa.sheppard[@]vcuhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• SIS TALK Back Intervention
The participants in this arm will be seen by a trained survivor coach and receive culturally tailored intervention materials.

Locations

Country	Name	City	State
United States	Massey Cancer Center	Richmond	Virginia
United States	Medstar Georgetown University Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	36 Months
Secondary	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.	36 Months
Secondary	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.	36 Months
Secondary	Determine Process and Implementation Outcomes	Assess the number of participants who Consent to Participate in the trial	36 Months
Secondary	Determine Process and Implementation Outcomes	Assess the number of participants that participate in the trial after they sign consent	36 Months
Secondary	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	36 Months