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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SIS TALK Back Intervention
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer focused on measuring Breast Cancer, Black Women, Breast Cancer Survivor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Medstar Georgetown University HospitalRecruiting
  • Massey Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sisters Informing Sisters Sessions

Enhanced Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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).
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).

Secondary Outcome Measures

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.
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.
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.
Determine Process and Implementation Outcomes
Assess the number of participants who Consent to Participate in the trial
Determine Process and Implementation Outcomes
Assess the number of participants that participate in the trial after they sign consent
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

Full Information

First Posted
April 12, 2022
Last Updated
April 24, 2023
Sponsor
Virginia Commonwealth University
Collaborators
Georgetown University
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1. Study Identification

Unique Protocol Identification Number
NCT05334732
Brief Title
Improving Communication and Adherence in Black Breast Cancer Survivors (Sisters Informing Sisters)
Acronym
SIS
Official Title
Improving Communication and Adherence in Black Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Georgetown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Black Women, Breast Cancer Survivor

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
460 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sisters Informing Sisters Sessions
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SIS TALK Back Intervention
Intervention Description
The participants in this arm will be seen by a trained survivor coach and receive culturally tailored intervention materials.
Primary Outcome Measure Information:
Title
Assessing Study Adherence Behaviors- Initiation
Description
Initiation will be measured for all therapies based on the number of participants starting at least one cycle of prescribed therapy
Time Frame
36 Months
Title
Assessing Study Adherence Behaviors- Delay of Adjuvant or Endocrine Therapy.
Description
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).
Time Frame
36 Months
Title
Assessing Study Adherence Behaviors- Overall Chemotherapy Adherence
Description
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).
Time Frame
36 Months
Secondary Outcome Measure Information:
Title
Assess Perceived Involvement in Care: PCC Outcomes - Level of Engagement in Decision Making
Description
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.
Time Frame
36 Months
Title
Assess Perceived Involvement in Care: PCC Outcomes - Perceptions of Doctor Behaviors by determining a more patient-centered encounter vs a more biomedically focused encounter.
Description
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.
Time Frame
36 Months
Title
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
Description
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.
Time Frame
36 Months
Title
Determine Process and Implementation Outcomes
Description
Assess the number of participants who Consent to Participate in the trial
Time Frame
36 Months
Title
Determine Process and Implementation Outcomes
Description
Assess the number of participants that participate in the trial after they sign consent
Time Frame
36 Months
Title
Determine Process and Implementation Outcomes
Description
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
Time Frame
36 Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa B Sheppard, Ph.D
Phone
804-682-2700
Email
vanessa.sheppard@vcuhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Yvonne D Cummings, BS
Phone
804-828-0643
Email
yvonne.cummings@vcuhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa B Sheppard, Ph.D
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medstar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hurtado de Mendoza
Email
ahd28@georgetown.edu
First Name & Middle Initial & Last Name & Degree
Lucile Adams-Campbell
Facility Name
Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa B Sheppard, PhD
Phone
804-628-2700
Email
vanessa.sheppard@vcuhealth.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IPD available.

Learn more about this trial

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

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