Communication and Adherence Intervention for Breast Cancer
(SIS Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Virginia Commonwealth University
Disqualifiers: Non-black, Prior cancer treatment, others
No Placebo Group
Trial Summary
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.
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.
12345How 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.
12367Eligibility 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
Ability to speak English
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.
+5 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Massey Cancer CenterRichmond, VA
Medstar Georgetown University HospitalWashington, United States
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Who Is Running the Clinical Trial?
Virginia Commonwealth UniversityLead Sponsor
Georgetown UniversityCollaborator
References
The attitudes, communication, treatment, and support intervention to reduce breast cancer treatment disparity. [2022]to test the effect of a supportive, one-time psychoeducational intervention on treatment adherence among African American women receiving first adjuvant therapy for breast cancer.
Adherence to endocrine therapy in women with breast cancer: development and preliminary validation of the A-BET questionnaire. [2022]To develop an Italian tool that measures the therapy adherence of women with breast cancer undergoing treatment with oral endocrine therapy.
Facilitators and barriers to medication adherence with adjuvant endocrine therapy in women with breast cancer: a structural equation modelling approach. [2021]To identify a structure to explain the relationship between socio-clinico factors, necessity-concerns beliefs, and perceived barriers to adherence with adjuvant endocrine therapy (AET) amongst women with breast cancer.
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]Patient adherence to adjuvant endocrine therapy (AET) after a diagnosis of hormone-sensitive breast cancer is poor. Previous interventions have failed to produce changes in adherence, address patient preferences or include theoretically informed and evidence-based components. Therefore, we iteratively developed a patient-centred, evidence-based, small-group, videoconference intervention to improve adherence and symptom management as well as reduce distress for patients taking AET after breast cancer (Symptom-Targeted Randomised Intervention for Distress and Adherence to Adjuvant Endocrine Therapy, STRIDE).
Oral Anticancer Agents: An Intervention to Promote Medication Adherence and Symptom Management . [2022]Symptom burden and poor adherence to oral anticancer agents remain significant clinical problems. This study examined feasibility, preliminary efficacy, and satisfaction with ADHERE, a nurse practitioner intervention that promotes symptom management and adherence among patients prescribed oral agents. The intervention group (which received one semistructured, face-to-face session followed by three weekly telephone sessions using motivational interviewing, brief cognitive-behavioral therapy, and a toolkit to promote self-management) had significantly lower symptom severity postintervention. Self-reported adherence was high and did not differ by group. Patients reported being highly satisfied with the ADHERE intervention. .
Both "Vitamin L for Life" and "One Milligram of Satan": A Multi-Perspective Qualitative Exploration of Adjuvant Endocrine Therapy Use after Breast Cancer. [2021]Adjuvant endocrine therapy (AET) is recommended after hormone receptor-positive breast cancer to reduce risk of recurrence, but adherence is sub-optimal in many women. Behavioral interventions have been ineffective in improving adherence rates to AET. This qualitative descriptive study investigates factors that support women in AET use and suggestions for interventions to improve AET use and management. Interviews with women who persisted with AET (n = 23), women who discontinued AET (n = 15), and healthcare providers (HCPs; oncologists, oncology residents, and pharmacists; n = 9) were conducted, transcribed, and described using thematic analysis. Data collection stopped once saturation occurred (i.e., no new codes or themes emerged during interviews). Two researchers created codes and developed themes in an iterative process; a third researcher verified the representativeness of final themes. This study was approved by the Health Research Ethics Board of Alberta (ID: HREBA.CC-17-0513). Women who persisted described being prepared for side effects and having self-management strategies, strong rationale for AET use, supportive HCPs, and available resources as relevant factors. Women who discontinued described feeling overwhelmed by side effects, information needs, drawbacks of AET, helpful/unhelpful experiences with HCPs, and contextual factors as relevant to their discontinuation. HCPs described health system-related and patient-related barriers, side effect management, and patient-provider interactions as relevant to supporting AET use. The considerable overlap in themes among the three groups suggests broad recognition of salient factors relevant to AET use and that associated strategies to improve use may be acceptable to patients and providers alike. Factors supporting AET use could include the following: education (which may be necessary but insufficient), developing a strong personal rationale for use, being prepared for side effects, having side effect management strategies, reciprocal communication between patients and HCPs, and accessible resources.
The effect of telephone social support and education on adaptation to breast cancer during the year following diagnosis. [2019]To find the most effective methods of providing social support for women diagnosed with breast cancer by testing the effectiveness of a telephone social support and education intervention to promote emotional and interpersonal adaptation to breast cancer.