Patient-Centered Communication Interventions for Breast Cancer

(SHARES Trial)

Not currently recruiting at 30 trial locations

Overseen By Sarah T. Hawley, PhD, MPH

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Alliance for Clinical Trials in Oncology

Disqualifiers: Visual impairment, Dementia, Memory loss, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve communication and decision-making for breast cancer treatment by testing two new methods. One method enhances a website called iCanDecide to help manage worry and anxiety about treatment. The other provides doctors with a dashboard showing patient concerns after using the website. The trial seeks women recently diagnosed with stage 0-III breast cancer who are planning surgery soon and can communicate in English or Spanish.

As an unphased study, this trial offers a unique opportunity to contribute to research that may enhance patient-doctor communication and improve treatment experiences.

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 prior data suggests that these interventions are safe for breast cancer patients?

Research has shown that the iCanDecide website, in both its enhanced (iCanDecide-ESE) and standard (iCanDecide-S) versions, helps women with early-stage breast cancer make better treatment decisions. This interactive tool aims to improve patient communication and decision-making regarding treatment plans.

No reports have linked harmful effects or negative experiences directly to using this decision-making tool. The primary goal is to help patients manage feelings like worry and anxiety about their treatment choices.

This trial is labeled "Not Applicable" in terms of phases, as it focuses on behavior and decision support rather than testing a new drug or medical treatment. The website's purpose is to guide and inform patients, not to treat them directly, so safety concerns are minimal. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these communication interventions for breast cancer because they focus on empowering patients through personalized information and decision-making tools. Unlike traditional treatments that center around medical procedures and medications, these interventions use innovative websites, iCanDecide - ESE and iCanDecide - S, to enhance patient understanding and involvement in their care choices. By providing tailored information and support, these tools aim to improve patient-clinician communication and ultimately lead to more informed and satisfying healthcare decisions. This approach could significantly shift the focus from purely clinical outcomes to patient-centered care, making it a groundbreaking development in breast cancer treatment.

What evidence suggests that this trial's interventions could be effective for breast cancer treatment?

Research has shown that the iCanDecide tools help patients make better-informed choices about their breast cancer treatment. In this trial, participants will use either the improved iCanDecide (iCanDecide-ESE) or the standard version (iCanDecide-S). Studies indicate that patients using the interactive version of iCanDecide were more likely to make high-quality treatment decisions. The improved iCanDecide-ESE reduces worry, distress, and anxiety by offering emotional support. Both versions aim to enhance communication and decision-making for women newly diagnosed with early-stage breast cancer. Overall, these tools are designed to help patients feel more confident about their treatment choices. ^{1 4 6 7 8}

Who Is on the Research Team?

Sarah T. Hawley, PhD, MPH

Principal Investigator

University of Michigan School of Medicine and Public Health

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Patients utilize the iCanDecide website (either ESE or S version) and undergo surgery within 5 weeks of registration

5 weeks

1 visit (in-person) for surgery

Follow-up

Participants are monitored for patient knowledge, self-efficacy, and cancer worry at 4-5 weeks and 9 months post-randomization

9 months

2 visits (virtual or phone interview)

Clinician Dashboard Training and Use

Clinicians receive training on the CDB and utilize it over a period of 60 weeks, with varying start times depending on practice randomization

60 weeks

What Are the Treatments Tested in This Trial?

Interventions

• iCanDecide - ESE website
• iCanDecide - S website

Trial Overview

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.

How Is the Trial Designed?

Group I: Clinics 9-11 (CDB) Experimental Treatment 4 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 Treatment 4 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 Treatment 4 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 Treatment 4 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 Treatment 4 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 Treatment 4 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 Treatment 5 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 Control 5 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 Control 4 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.

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A qualitative study involving 41 breast cancer patients in Spain revealed that while the information provided during oncologic care is generally appropriate and personalized, it can also be inconsistent and contradictory, leading to gaps in continuity of care.

To better meet patients' information needs, healthcare providers must ensure both physical access to information and intellectual understanding, taking into account social and cultural factors that influence communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer patients' narrative experiences about communication during the oncology care process: a qualitative study. Abt Sacks, A., Perestelo-Perez, L., Rodriguez-Martin, B., et al.[2017]

The Cancer Information Service (CIS) provides essential support to patients and their families through various communication channels, helping them understand complex cancer-related issues.

By empowering patients with knowledge about their disease and treatment options, the CIS enables them to make informed decisions and effectively communicate with their healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The cancer information service (CIS) of the German Cancer Research Center]. Gaisser, A.[2019]

The National Cancer Institute's Cancer Information Service (CIS) plays a crucial role in enhancing patient-centered communication by incorporating six core functions, which include fostering healing relationships and managing uncertainty, to improve the overall patient experience in cancer care.

CIS training and quality management systems are designed to support clinicians in delivering effective communication, highlighting the importance of these systems in future health information delivery and research efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered communication in cancer care: the role of the NCI's Cancer Information Service. Perocchia, RS., Hodorowski, JK., Williams, LA., et al.[2021]

The iCanDecide interactive decision tool significantly improved the likelihood of patients making high-quality treatment decisions for early-stage breast cancer, with an odds ratio of 2.00, primarily by enhancing their knowledge about treatment options.

While both groups made similar rates of values-concordant decisions (around 79% in the intervention group), the iCanDecide tool also increased decision preparation among users, suggesting that interactive tools can enhance patient engagement in their treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Breast Cancer Surgical Treatment Decision Making: The iCanDecide Randomized Clinical Trial. Hawley, ST., Li, Y., An, LC., et al.[2019]

A systematic review of 14 studies involving 2374 breast cancer patients found that Internet or interactive computer-based education programs can significantly increase patients' knowledge about breast cancer.

While these programs showed positive effects on knowledge, the impact on other outcomes related to patient empowerment and participation varied, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of Internet or interactive computer-based patient education in the field of breast cancer: a systematic literature review. Ryhänen, AM., Siekkinen, M., Rankinen, S., et al.[2022]

A new mobile app designed for women with breast cancer provides personalized narratives and tailored information about surgery, based on in-depth interviews with 35 Canadian women, addressing their specific needs and preferences.

Pilot testing of the app showed positive feedback, indicating that combining experiential evidence with technology can effectively help patients navigate the overwhelming information they receive after a breast cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Ormel, I., Onu, CC., Magalhaes, M., et al.[2021]

The ongoing randomized controlled trial aims to assess the effectiveness of an interactive online decision tool, iCanDecide, in helping newly diagnosed breast cancer patients make informed treatment choices, with a target of 222 participants per arm across multiple states.

The study hypothesizes that patients using the interactive version of iCanDecide will make higher quality decisions regarding their treatment options compared to those using a static version, potentially leading to better patient satisfaction and alignment with their personal values.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol: A Randomized Controlled Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool (iCanDecide). Hawley, ST., Li, Y., Jeanpierre, LA., et al.[2022]

In a study involving 147 women newly diagnosed with breast cancer, patient-centered communication (PCC) behaviors, such as patients asserting treatment preferences and surgeons providing hopeful news, significantly increased patient satisfaction with their surgeons.

Higher patient satisfaction was linked to a notable decrease in feelings of hopelessness after consultations, suggesting that effective PCC can improve psychosocial outcomes for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consultations between patients with breast cancer and surgeons: a pathway from patient-centered communication to reduced hopelessness. Robinson, JD., Hoover, DR., Venetis, MK., et al.[2021]

Patients with cancer and their caregivers emphasized the need for proactive and clear communication about medical information during public health crises, highlighting its importance for preparing for care.

Involving caregivers in communication, even when they cannot be physically present, and fostering two-way communication for shared decision-making are crucial for providing patient-centered care during vulnerable times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Singh, N., Giannitrapani, KF., Gamboa, RC., et al.[2023]

Patients with cancer, especially those with advanced breast cancer, often struggle with engagement in their care due to factors like fear and poor clinician-patient relationships, which can negatively impact their physical and emotional health.

Effective support from cancer nurses, characterized by open communication and understanding of patients' emotional needs, is crucial for improving patient engagement and self-management in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of the Nurse in Patient Education and Engagement and Its Importance in Advanced Breast Cancer. Oakley, C., Ream, E.[2023]

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V-Safe Data - ICAN

Updated V-Safe Free-Text Data. This data contains the entries made by V-safe users in the open text fields (or “free text” fields) of the V-safe check-ins.