150 Participants Needed

Communication and Adherence Intervention for Breast Cancer

(SIS Trial)

Recruiting at 1 trial location
VB
YD
Overseen ByYvonne D Cummings, BS
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Virginia Commonwealth University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study involves patients who have not yet started chemotherapy or endocrine therapy, it's best to discuss your current medications with the study team.

What data supports the effectiveness of the SIS TALK Back Intervention treatment for breast cancer?

The ADHERE intervention, which shares components like motivational interviewing and cognitive-behavioral therapy with the SIS TALK Back Intervention, showed that patients had lower symptom severity and high satisfaction, suggesting these methods can help with treatment adherence and symptom management.12345

How is the SIS TALK Back Intervention treatment different from other breast cancer treatments?

The SIS TALK Back Intervention is unique because it focuses on improving communication and adherence to treatment through supportive and educational strategies, rather than relying solely on medication. This approach aims to address the emotional and interpersonal aspects of breast cancer treatment, which are often overlooked in traditional therapies.12367

What is the purpose of this trial?

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.

Research Team

dir VCU School of Medicine

Vanessa Sheppard, PhD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

This trial is for Black women who have been recently diagnosed with breast cancer (stage I-III), haven't started systemic therapy like chemotherapy or endocrine therapy, and haven't had any other cancer treatments in the last two years. Participants must be able to speak and read English, provide consent, and their doctors need to be licensed.

Inclusion Criteria

I haven't had cancer treatment in the last 2 years, except for skin cancer.
I am capable of understanding and consenting to participate in the study.
I am eligible for, but have not started, chemotherapy or hormone therapy.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Sisters Informing Sisters intervention or enhanced usual care

36 months
Regular sessions with survivor coach or standard care visits

Follow-up

Participants are monitored for adherence to systemic therapy and patient-centered communication

36 months

Treatment Details

Interventions

  • SIS TALK Back Intervention
Trial Overview The study is testing an intervention called 'SIS TALK Back' aimed at improving adherence to systemic therapies among Black breast cancer survivors. It will compare this new approach against what's normally done in these cases.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Sisters Informing Sisters SessionsExperimental Treatment1 Intervention
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.
Group II: Enhanced Usual CareActive Control1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials
732
Recruited
22,900,000+

Georgetown University

Collaborator

Trials
355
Recruited
142,000+

Findings from Research

The ACTS psychoeducational intervention, a one-time 45-minute session led by an African American breast cancer survivor, showed promising results in improving chemotherapy initiation and adherence among 24 African American women, with 100% of participants starting treatment compared to 82% in the usual care group.
Participants in the ACTS intervention also demonstrated better overall adherence to chemotherapy, receiving 94% of their prescribed doses compared to 74% in the usual care group, highlighting the potential effectiveness of tailored support in addressing treatment barriers for this population.
The attitudes, communication, treatment, and support intervention to reduce breast cancer treatment disparity.Rosenzweig, M., Brufsky, A., Rastogi, P., et al.[2022]
A new Italian questionnaire, A-BET, was developed to measure therapy adherence among women with breast cancer undergoing oral endocrine therapy, validated with 82 patients, showing excellent content validity and strong internal consistency.
The tool assesses adherence levels, patient awareness of their medication, and factors influencing non-adherence, providing healthcare professionals with a valuable resource to improve patient care and treatment outcomes.
Adherence to endocrine therapy in women with breast cancer: development and preliminary validation of the A-BET questionnaire.Gambalunga, F., Iacorossi, L., Terrenato, I., et al.[2022]
In a study of 244 women with early-stage breast cancer, older age was linked to better adherence to adjuvant endocrine therapy (AET), while higher perceived barriers negatively impacted adherence.
Interestingly, beliefs about the necessity of the medication or concerns about it did not significantly influence adherence, with forgetfulness being the most common reason for not taking the medication as prescribed.
Facilitators and barriers to medication adherence with adjuvant endocrine therapy in women with breast cancer: a structural equation modelling approach.Tan, EH., Wong, ALA., Tan, CC., et al.[2021]

References

The attitudes, communication, treatment, and support intervention to reduce breast cancer treatment disparity. [2022]
Adherence to endocrine therapy in women with breast cancer: development and preliminary validation of the A-BET questionnaire. [2022]
Facilitators and barriers to medication adherence with adjuvant endocrine therapy in women with breast cancer: a structural equation modelling approach. [2021]
Study protocol for a randomised controlled feasibility trial of a virtual intervention (STRIDE) for symptom management, distress and adherence to adjuvant endocrine therapy after breast cancer. [2021]
Oral Anticancer Agents: An Intervention to Promote Medication Adherence and Symptom Management . [2022]
Both "Vitamin L for Life" and "One Milligram of Satan": A Multi-Perspective Qualitative Exploration of Adjuvant Endocrine Therapy Use after Breast Cancer. [2021]
The effect of telephone social support and education on adaptation to breast cancer during the year following diagnosis. [2019]
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