Communication and Adherence Intervention for Breast Cancer

(SIS Trial)

Recruiting at 1 trial location

Overseen By Yvonne D Cummings, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Non-black, Prior cancer treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

Who Is on the Research Team?

Vanessa Sheppard, PhD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Sisters Informing Sisters Sessions Experimental Treatment 1 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 Care Active Control 1 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.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The STRIDE intervention, a patient-centered videoconference program, aims to improve adherence to adjuvant endocrine therapy (AET) in breast cancer patients by addressing symptom management and reducing distress, with a feasibility trial involving 75 participants.

This study will objectively monitor medication adherence using electronic pill bottles and assess the intervention's impact on patient satisfaction and symptom distress over 24 weeks, providing valuable insights into effective support strategies for AET adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Jacobs, JM., Rapoport, CS., Horenstein, A., et al.[2021]

The ADHERE intervention, which included a face-to-face session and three follow-up phone calls, significantly reduced symptom severity in patients taking oral anticancer agents, indicating its effectiveness in symptom management.

Patients reported high satisfaction with the ADHERE program, and self-reported adherence to medication was high across both the intervention and control groups, suggesting that the intervention did not negatively impact adherence rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Anticancer Agents: An Intervention to Promote Medication Adherence and Symptom Management . Spoelstra, SL., Sikorskii, A., Majumder, A., et al.[2022]

A qualitative study involving 23 women who continued adjuvant endocrine therapy (AET) and 15 who discontinued, along with 9 healthcare providers, identified key factors that support AET adherence, including preparedness for side effects, strong personal rationale for treatment, and supportive healthcare provider relationships.

Women who discontinued AET often felt overwhelmed by side effects and lacked sufficient information, highlighting the need for better communication and resources to manage side effects and improve adherence to AET.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Both "Vitamin L for Life" and "One Milligram of Satan": A Multi-Perspective Qualitative Exploration of Adjuvant Endocrine Therapy Use after Breast Cancer. Toivonen, KI., Oberoi, D., King-Shier, K., et al.[2021]

A study involving 197 women with nonmetastatic breast cancer found that both telephone social support and mailed educational resource kits improved emotional and interpersonal adaptation, but there were no significant differences between the two methods.

The results suggest that mailed educational kits alone can be as effective as telephone support from oncology nurses, indicating a potentially more cost-effective approach to providing support, though regional differences should be considered in future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of telephone social support and education on adaptation to breast cancer during the year following diagnosis. Coleman, EA., Tulman, L., Samarel, N., et al.[2019]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

The attitudes, communication, treatment, and support intervention to reduce breast cancer treatment disparity. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Adherence to endocrine therapy in women with breast cancer: development and preliminary validation of the A-BET questionnaire. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Facilitators and barriers to medication adherence with adjuvant endocrine therapy in women with breast cancer: a structural equation modelling approach. [2021]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

Oral Anticancer Agents: An Intervention to Promote Medication Adherence and Symptom Management . [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Both "Vitamin L for Life" and "One Milligram of Satan": A Multi-Perspective Qualitative Exploration of Adjuvant Endocrine Therapy Use after Breast Cancer. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

The effect of telephone social support and education on adaptation to breast cancer during the year following diagnosis. [2019]