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NCT Number: NCT05334732

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MedStar Washington Hospital Center, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SIS TALK Back Intervention

Behavioral

The participants in this arm will be seen by a trained survivor coach and receive culturally tailored intervention materials.

Primary outcomes

  1. 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

  2. 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).

  3. 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).

Secondary outcomes

  1. Assess Perceived Involvement in Care: PCC Outcomes - Level of Engagement in Decision Making

    Time frame: 36 Months

    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.

  2. 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

    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.

  3. 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

    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.

  4. Determine Process and Implementation Outcomes

    Time frame: 36 Months

    Assess the number of participants who Consent to Participate in the trial

  5. Determine Process and Implementation Outcomes

    Time frame: 36 Months

    Assess the number of participants that participate in the trial after they sign consent

  6. Determine Process and Implementation Outcomes

    Time frame: 36 Months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Vanessa B Sheppard, Ph.D

CONTACT

[email protected]

804-682-2700

Yvonne D Cummings, BS

CONTACT

[email protected]

804-828-0643

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Georgetown University

Registry information

Official study title

Improving Communication and Adherence in Black Breast Cancer Survivors

Acronym: SIS

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Apr 19, 2022
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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