Communication and Adherence Intervention for Breast Cancer

(SIS Trial)

Recruiting at 3 trial locations

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

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new approach called the SIS TALK Back Intervention, designed to help Black women adhere to their breast cancer treatment plans. The intervention uses peer support and motivational techniques to encourage better adherence to prescribed therapies. Researchers will compare participants to those receiving standard care information through a booklet. The trial seeks Black women recently diagnosed with stage I-III breast cancer who have not yet started chemotherapy or hormone therapy. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance treatment adherence and outcomes for Black women with breast cancer.

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 prior data suggests that the SIS TALK Back Intervention is safe?

Research has shown that the SIS TALK Back Intervention is likely safe for participants. Past studies with similar peer-based programs found no major differences in serious health events, recurrences, or deaths compared to regular care. This suggests the intervention is generally well-tolerated and doesn't increase risk for participants. The main focus is on support and communication, which are usually low-risk. However, as with any study, participants should monitor their well-being and report any concerns to the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SIS TALK Back Intervention for breast cancer because it takes a unique peer-based approach to improving patient communication and treatment adherence. Unlike typical treatments that focus solely on medication, this intervention involves survivor coaches who use Motivational Interviewing techniques to guide patients. This method emphasizes positive role modeling and provides culturally relevant support, aimed at enhancing patients' engagement with their treatment plans. By addressing the human side of healthcare, this intervention has the potential to significantly boost adherence and improve outcomes for breast cancer patients.

What evidence suggests that the SIS TALK Back Intervention is effective for increasing adherence to systemic therapy in Black women with breast cancer?

Research shows that the SIS TALK Back Intervention, a treatment arm in this trial, might help Black women with breast cancer adhere to their treatment plans more effectively. This program employs peer support, where survivor coaches guide patients through their treatment journey. It incorporates motivational interviewing to encourage adherence and provide support. Studies have found that effective communication and peer support can lead to better treatment outcomes. Early findings suggest that these interventions may enhance adherence and communication, which are crucial for effective cancer care. ^{6 7 8 9 10}

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

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]

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 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 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]

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]

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. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05334732/improving-communication-and-adherence-in-black-breast-cancer-survivors-sisters-informing-sisters

Improving Communication and Adherence in Black Breast ... The purpose of this study is to test an evidence-based intervention designed to increase adherence to systemic therapy in Black women ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3136087/

Development of Decision Support Intervention for Black ... Thirty-four in-depth interviews were conducted with breast cancer patients in active treatment, survivors and cancer providers to gather qualitative data.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4180493/

A Peer-Led Decision Support Intervention Improves Decision ... Good communication and participatory encounters may increase rates of optimal treatment and may improve cancer outcomes. Some data suggest that Black breast ...

4. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/340143

Improving Communication and Adherence in Black Breast ... Experimental: Sisters Informing Sisters Sessions. The intervention is peer-based and in concert with our theoretical model, builds upon positive role-modeling ...

5. withpower.com withpower.com/trial/phase-breast-neoplasms-2-2021-90947

Communication and Adherence Intervention for Breast ... The SIS TALK Back Intervention is unique because it focuses on improving communication and adherence to treatment through supportive and educational strategies, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25469673/

SIS.NET: a randomized controlled trial evaluating a web- ... Results: A total of 102 participants were enrolled; 2 patients were excluded due to cancer recurrence. In the SIS.NET arm, 74% of new or changed ...

7. trial.medpath.com trial.medpath.com/clinical-trial/9f0882c9cd440165/nct01308775-pilot-study-patient-centered-symptom-reporting-breast-cancer

Comparing (SIS.NET) to Standard Care in Patients Who Have ... This study found no statistically significant differences in number of recurrences, deaths, recurrence related serious clinical events, or patient reported ...

8. researchgate.net researchgate.net/publication/269042252_SISNET_A_Randomized_Controlled_Trial_Evaluating_a_Web-Based_System_for_Symptom_Management_After_Treatment_of_Breast_Cancer

SIS.NET: A Randomized Controlled Trial Evaluating a Web ... We expect that the GSD intervention may enhance the patients' adjustment to life after breast cancer, which could strengthen their ability to ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10776597/

Telehealth in breast cancer following the coronavirus disease ... Some cancer groups worldwide have recommended then the use of telemedicine for oncology patients to ensure the continuity of medical care during the pandemic.

10. clinicaltrials.gov clinicaltrials.gov/study/NCT04379570

Study Details | NCT04379570 | Additional Support ... This phase III trial compares an additional support program (text message reminders and/or telephone-based counseling) with usual care in making sure breast ...