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Patient-Centered Communication Interventions for Breast Cancer
(SHARES Trial)

Not currently recruiting at 30 trial locations

Overseen BySarah 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 GroupAll trial participants will receive the active study treatment (no placebo)

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.

See 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.

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?

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

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]

Citations

1.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC9817354/

Improving patient-centered communication in breast cancerThis study will cross a patient-level randomization of an emotional support enhanced version of the iCanDecide breast cancer treatment decision ...

2.ebccp.cancercontrol.cancer.govebccp.cancercontrol.cancer.gov/programDetails.do;jsessionid=AB9FC4099D8F74007DCC169FE42FE0B5?programId=32833908

iCanDecide | Evidence-Based Cancer Control Programs ...iCanDecide is an interactive website designed to improve decision-making about treatment among women newly diagnosed with early-stage breast cancer.

3.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC5946719/

Improving Breast Cancer Surgical Treatment Decision ...This study was conducted to determine the effect of iCanDecide, an interactive and tailored breast cancer treatment decision tool, ...

4.centerwatch.comcenterwatch.com/clinical-trials/listings/NCT04549571/improving-patient-centered-communication-in-breast-cancer-through-patient-and-provider-interventions

Improving Patient-Centered Communication in Breast ...This trial studies the effectiveness of two interventions on patient reported outcomes of patient centered communication and decision making ...

5.withpower.comwithpower.com/trial/phase-breast-neoplasms-2021-6455e

Patient-Centered Communication Interventions for Breast ...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.

6.clinicaltrials.govclinicaltrials.gov/study/NCT04549571

Study Details | NCT04549571 | Improving Patient-Centered ...To demonstrate that the enhanced iCanDecide (iCanDecide-ESE) intervention is more effective than the standard version (iCanDecide-S), resulting in higher ...

7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/29364772/

Improving Breast Cancer Surgical Treatment Decision MakingThis study was conducted to determine the effect of iCanDecide, an interactive and tailored breast cancer treatment decision tool, on the rate of high-quality ...

8.icandecide.orgicandecide.org/v-safe-data/

V-Safe Data - ICANUpdated 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.

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Patient-Centered Communication Interventions for Breast Cancer
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What You Need to Know Before You Apply

Who Is on the Research Team?

Are You a Good Fit for This Trial?

Timeline for a Trial Participant

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

Published Research Related to This Trial

Citations

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Patient-Centered Communication Interventions for Breast Cancer (SHARES Trial)

What You Need to Know Before You Apply

Who Is on the Research Team?

Are You a Good Fit for This Trial?

Timeline for a Trial Participant

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

Published Research Related to This Trial

Citations

Other People Viewed

Related Searches

Patient-Centered Communication Interventions for Breast Cancer
(SHARES Trial)