Breast Cancer
Conditions
Keywords
Breast Cancer, Black Women, Breast Cancer Survivor
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.
Interventions
BEHAVIORALSIS TALK Back Intervention
The participants in this arm will be seen by a trained survivor coach and receive culturally tailored intervention materials.
Sponsors
Virginia Commonwealth University
Georgetown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessing Study Adherence Behaviors- Initiation | 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. | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Assess Perceived Involvement in Care: PCC Outcomes - Level of Engagement in Decision Making | 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. |
| 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 | 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 | 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. |
| Determine Process and Implementation Outcomes | 36 Months | Assess the number of participants who Consent to Participate in the trial |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVanessa B Sheppard, Ph.D
Virginia Commonwealth University
Outcome results
None listed