Patient-Centered Communication Interventions for Breast Cancer

(SHARES Trial)

Recruiting at29 trial locations

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

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. ^{1 2 3 4 5}

How 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. ^{6 7 8 9 10}

Research Team

Sarah T. Hawley, PhD, MPH

Principal Investigator

University of Michigan School of Medicine and Public Health

Eligibility 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.

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.

Trial Timeline

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

Treatment Details

Interventions

• iCanDecide - ESE website (Behavioural Intervention)
• iCanDecide - S website (Behavioural Intervention)

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.

Participant Groups

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+

Suzanne George

Alliance for Clinical Trials in Oncology

Chief Medical Officer since 2015

MD from Harvard Medical School

Evanthia Galanis

Alliance for Clinical Trials in Oncology

Chief Executive Officer since 2022

MD from Mayo Clinic

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Improving Breast Cancer Surgical Treatment Decision Making: The iCanDecide Randomized Clinical Trial. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Study protocol: A Randomized Controlled Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool (iCanDecide). [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Role of the Nurse in Patient Education and Engagement and Its Importance in Advanced Breast Cancer. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Consultations between patients with breast cancer and surgeons: a pathway from patient-centered communication to reduced hopelessness. [2021]

5. Ireland 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Breast cancer patients' narrative experiences about communication during the oncology care process: a qualitative study. [2017]

7. United States 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. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Patient-centered communication in cancer care: the role of the NCI's Cancer Information Service. [2021]

10. Canada 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. [2021]