Patient-Centered Communication Interventions for Breast Cancer
(SHARES Trial)
Recruiting in Palo Alto (17 mi)
+26 other locations
Age: Any Age
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Alliance for Clinical Trials in Oncology
Disqualifiers: Visual impairment, Dementia, Memory loss, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial studies an improved online tool and a doctor dashboard to help breast cancer patients make better treatment decisions and reduce their anxiety.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the iCanDecide treatment for breast cancer?
The iCanDecide treatment, an interactive online tool, was shown to help breast cancer patients make better-informed decisions about their treatment by improving their knowledge. In a study, patients using the interactive version of iCanDecide were more likely to make high-quality decisions compared to those using a static version.
12345How does the patient-centered communication treatment for breast cancer differ from other treatments?
This treatment focuses on improving communication between patients and healthcare providers, which is unique compared to traditional medical treatments. It aims to enhance understanding, decision-making, and emotional support, rather than directly targeting the cancer itself.
678910Eligibility Criteria
This trial is for English or Spanish-speaking women aged 21-84 with stage 0-III breast cancer, planning surgery within 5 weeks of joining. Participating surgeons and their teams must consent to use a clinician dashboard. Practices treating over 100 new breast cancer patients annually can join. Excluded are those with impaired decision-making, visual impairment, or enrolled in Alliance A231701CD.Inclusion Criteria
My healthcare team includes a surgical oncologist participating in the study.
I am scheduled for breast surgery within 5 weeks as part of my treatment.
I am between 21 and 84 years old.
+6 more
Exclusion Criteria
Practices currently enrolling to Alliance A231701CD are not eligible to participate in this study
Patients who are visually impaired are not eligible, as they must be able to access the study intervention on a website at home or in clinic and view the decision aid
I am capable of making my own health decisions.
Participant Groups
The study tests two interventions: an enhanced iCanDecide tool aiding in managing worry during treatment decisions versus the existing version; and a clinician dashboard that tracks patient concerns post-website visit to improve communication and decision making.
9Treatment groups
Experimental Treatment
Active Control
Group I: Clinics 9-11 (CDB)Experimental Treatment4 Interventions
Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 20-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.
Group II: Clinics 6-8 (CDB)Experimental Treatment4 Interventions
Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 10-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.
Group III: Clinics 18-20 (CDB)Experimental Treatment4 Interventions
Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 50-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.
Group IV: Clinics 15-17 (CDB)Experimental Treatment4 Interventions
Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 40-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.
Group V: Clinics 12-14 (CDB)Experimental Treatment4 Interventions
Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 30-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.
Group VI: Clinics 1-5: (CDB)Experimental Treatment4 Interventions
Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 1-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.
Group VII: Arm I: (iCanDecide - ESE)Experimental Treatment5 Interventions
Patients utilize the iCanDecide - ESE website, then undergo surgery within 5 weeks of registration. Patients may also participate in an audio-recorded phone interview over 20 minutes at 9-12 months post registration.
Group VIII: Arm II: (iCanDecide - S)Active Control5 Interventions
Patients utilize the iCanDecide - S website, then undergo surgery within 5 weeks of registration. Patients may also participate in an audio-recorded phone interview over 20 minutes at 9-12 months post registration.
Group IX: Clinics 21-25 (usual care)Active Control4 Interventions
Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and continue to provide breast cancer surgical care per their usual care. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Corewell Health Grand Rapids Hospitals - Butterworth HospitalGrand Rapids, MI
Saint Ann's HospitalWesterville, OH
Sanford Bismarck Medical CenterBismarck, ND
Montefiore Medical Center-Einstein CampusBronx, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Alliance for Clinical Trials in OncologyLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Improving Breast Cancer Surgical Treatment Decision Making: The iCanDecide Randomized Clinical Trial. [2019]Purpose This study was conducted to determine the effect of iCanDecide, an interactive and tailored breast cancer treatment decision tool, on the rate of high-quality patient decisions-both informed and values concordant-regarding locoregional breast cancer treatment and on patient appraisal of decision making. Methods We conducted a randomized clinical trial of newly diagnosed patients with early-stage breast cancer making locoregional treatment decisions. From 22 surgical practices, 537 patients were recruited and randomly assigned online to the iCanDecide interactive and tailored Web site (intervention) or the iCanDecide static Web site (control). Participants completed a baseline survey and were mailed a follow-up survey 4 to 5 weeks after enrollment to assess the primary outcome of a high-quality decision, which consisted of two components, high knowledge and values-concordant treatment, and secondary outcomes (decision preparation, deliberation, and subjective decision quality). Results Patients in the intervention arm had higher odds of making a high-quality decision than did those in the control arm (odds ratio, 2.00; 95% CI, 1.37 to 2.92; P = .0004), which was driven primarily by differences in the rates of high knowledge between groups. The majority of patients in both arms made values-concordant treatment decisions (78.6% in the intervention arm and 81.4% in the control arm). More patients in the intervention arm had high decision preparation (estimate, 0.18; 95% CI, 0.02 to 0.34; P = .027), but there were no significant differences in the other decision appraisal outcomes. The effect of the intervention was similar for women who were leaning strongly toward a treatment option at enrollment compared with those who were not. Conclusion The tailored and interactive iCanDecide Web site, which focused on knowledge building and values clarification, positively affected high-quality decisions largely by improving knowledge compared with static online information. To be effective, future patient-facing decision tools should be integrated into the clinical workflow to improve decision making.
Study protocol: A Randomized Controlled Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool (iCanDecide). [2022]Patients newly diagnosed with breast cancer face a series of complex decisions regarding locoregional and systemic treatment. There is a need to improve the quality of locoregional and systemic decisions for breast cancer patients, and to help patients understand the role of evaluative tests in this decision process. We are now conducting a randomized controlled trial (RCT) of an online decision tool-called iCanDecide, which we expect will help patients with these difficult decisions. Furthermore, the results of this RCT will be highly relevant to future breast cancer patients making these decisions and to their clinicians.
Role of the Nurse in Patient Education and Engagement and Its Importance in Advanced Breast Cancer. [2023]To show how people with cancer, including those with advanced breast cancer, engage with information and self-management and how cancer nurses can support patients to manage important aspects of care. Epstein and Street's patient-centered communication in cancer care (PCC) model provides a useful framework. The model incorporates six domains representing core mediating functions of patient-centered communication (Fostering healing relationships, Exchanging information, Responding to emotions, Managing uncertainty, Making decisions, and Enabling self-management) and additional moderating factors for PCC and health outcomes.
Consultations between patients with breast cancer and surgeons: a pathway from patient-centered communication to reduced hopelessness. [2021]Patient-centered communication (PCC) affects psychosocial health outcomes of patients. However, these effects are rarely direct, and our understanding of such effects are largely based on self-report (v observational) data. More information is needed on the pathways by which concrete PCC behaviors affect specific psychosocial outcomes in cancer care. We hypothesized that PCC behaviors increase the satisfaction of patients with surgeons, which, in turn, reduces the postconsultation hopelessness of patients.
The effects of Internet or interactive computer-based patient education in the field of breast cancer: a systematic literature review. [2022]The aim of this systematic review was to analyze what kind of Internet or interactive computer-based patient education programs have been developed and to analyze the effectiveness of these programs in the field of breast cancer patient education. Patient education for breast cancer patients is an important intervention to empower the patient. However, we know very little about the effects and potential of Internet-based patient education in the empowerment of breast cancer patients.
Breast cancer patients' narrative experiences about communication during the oncology care process: a qualitative study. [2017]To analyse the perception about the information and communication received to evaluate oncologic care of breast cancer patients in Spain. Qualitative study based on conducting in-depth interviews. An inductive thematic analysis of the illness narratives was performed. Intentional theoretical sampling of 41 people diagnosed with breast cancer. The information provided during care process is assessed as appropriate, as it includes personalised skills focused on communication and considers organisational and contextual issues. In some cases, the information was considered partial, heterogeneous and at times contradictory, which revealed a lack of continuity. To provide and adequately cover information needs from the patient perspective, it is necessary to ensure access, both in its physical (material) and intellectual (comprehension) dimension, keeping in mind elements of social capital (social networks) and cultural capital (values, beliefs, non-verbal language) that facilitate or hinder access. The current state of transition to a horizontal model in the doctor-patient relationship, could account for the difficulties, deficits and contradictions in communication and information that breast cancer patients perceive in many contexts.
What Patients Facing Cancer and Caregivers Want From Communication in Times of Crisis: A Qualitative Study in the Early Months of the COVID-19 Pandemic. [2023]Interpersonal communication is a cornerstone of patient-centered care. We aimed to identify what patients with cancer and caregivers may want from communication during a public health crisis.
[The cancer information service (CIS) of the German Cancer Research Center]. [2019]Via the telephone, email and an internet portal,the CIS offers patients, their relatives and interested persons competent information and advice on the topic of cancer. A primary aim is to enable interested parties to understand what is often a complicated matter. In many cases, this is the sole empowerment for patients to communicate usefully with the family physician, and to put their own individual situation into proper perspective. A good grasp of their disease is also the prerequisite for taking appropriate decisions with regard to treatment. The most common questions asked are concerned with disease-specific therapeutic standards, the range of treatments available and the side effects and complications of treatment options.
Patient-centered communication in cancer care: the role of the NCI's Cancer Information Service. [2021]While patient-centered care and the reduction of suffering due to cancer are primary goals of the NCI, improvement in the delivery of patient-centered communication has been identified as a key NCI research priority. As research on patient-centered communication evolves, the potential contributions of programs such as the National Cancer Institute's (NCI) Cancer Information Service (CIS) cannot be overlooked. The purpose of this paper is to describe how the six core functions of patient-clinician communication described in the literature (fostering healing relationships, exchanging information, responding to emotions, managing uncertainty, making decisions and enabling patient-self management) are embedded in the work of the CIS. The communication process used by the CIS to extend the patient-centered communication role of the clinician will be discussed. CIS training and quality management systems will be described. Lastly, suggestions for the role of CIS in future health information delivery and research will be explored.
Using a Mobile App-Based Video Recommender System of Patient Narratives to Prepare Women for Breast Cancer Surgery: Development and Usability Study Informed by Qualitative Data. [2021]Women diagnosed with breast cancer are often bombarded with information. Such information overload can lead to misunderstandings and hamper women's capacity for making informed decisions about their care. For women with breast cancer, this uncertainty is particularly severe in the period before surgery. Personalized narratives about others' experiences can help patients better understand the disease course, the quality and type of care to be expected, the clinical decision-making processes, and the strategies for coping. Existing resources and eHealth apps rarely include experiential information, and no tools exist that tailor information for individual preferences and needs-offering the right information at the right time and in the right format. Combining high-quality experiential evidence with novel technical approaches may contribute to patient-centered solutions in this area.