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

N/A

Recruiting

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be able to speak English or Spanish with the fluency required to have a direct discussion around treatment decision-making (i.e. without interpreter)

Age 21-84 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 4-5 weeks post patient randomization

Awards & highlights

SHARES Trial Summary

This trial studies whether two different interventions can improve patient outcomes when making decisions about breast cancer treatment.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial focuses on communication tools rather than medical treatments, traditional physical side effects aren't expected. However, participants may experience emotional or psychological responses when engaging with the intervention materials.

SHARES Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can speak English or Spanish fluently enough to discuss my treatment without needing an interpreter.

Select...

I am between 21 and 84 years old.

Select...

A surgical oncologist from my team has agreed to participate and signed the consent.

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I am a woman newly diagnosed with early to locally advanced breast cancer.

SHARES Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 4-5 weeks post patient randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 4-5 weeks post patient randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 4-5 weeks post patient randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient knowledge about risks and benefits of local regional treatment

Secondary outcome measures

Patient cancer worry

Patient self-efficacy in dealing with breast cancer

Side effects data

From 2013 Phase 3 trial • 4312 Patients • NCT00011986

97%

Neutropenia

94%

Leukopenia

80%

Anemia

76%

Thrombocytopenia

47%

Gastrointestinal

43%

Constitutional

38%

Other Hemotologic

34%

Pain

17%

Infection/Fever

17%

Peripheral neurologic

17%

Pulmonary

14%

Neurologic

11%

Metabolic

10%

2nd Primary

Hepatic

Dermatologic

Cardiovascular

Allergy

Hemorrhage

Genitourinary/Renal

Musculoskeletal

Ocular/Visual

Endocrine

Auditory

Thrombosis/Embolism

Ileus

Infection Documented W Grd 3/4 Neutropn.

Infection Without Neutropenia

Coagulation

Sexual

Platelets

Allergic Reaction/Hypersensitivity

Febrile Neutropenia-Fuo Infect Not Docum

100%

80%

60%

40%

20%

Study treatment Arm

Carbo/Gemcitabine - Carbo/Taxol

Carbo/Taxol/Gemcitabine

Carbo/Taxol/Doxil

Carbo/Topotecan - Carbo/Taxol

Carbo/Taxol

SHARES Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9850

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,154 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Alliance for Clinical Trials in OncologyLead Sponsor

512 Previous Clinical Trials

216,938 Total Patients Enrolled

75 Trials studying Breast Cancer

40,143 Patients Enrolled for Breast Cancer

Sarah T. Hawley, PhD, MPHStudy ChairUniversity of Michigan School of Medicine and Public Health

2 Previous Clinical Trials

882 Total Patients Enrolled

1 Trials studying Breast Cancer

537 Patients Enrolled for Breast Cancer

Media Library

Therapeutic Conventional Surgery Clinical Trial Eligibility Overview. Trial Name: NCT04549571 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment quota for this research undertaking?

"Absolutely. According to clinicaltrials.gov, the trial was initially published on January 15th 2021 and last revised on September 25th 2022 - it is now actively recruiting 700 patients from a total of 25 sites across the country."

Answered by AI

How many US-based locations are currently partaking in the trial?

"A total of 25 clinical sites are available for this medical trial, with Sanford Broadway Medical Center in Fargo, Montefiore Medical Center-Einstein Campus in the Bronx and Good Samaritan Regional Health Centre in Mount Vernon being just some of them."

Answered by AI

Is recruitment underway for this trial?

"Reportedly, this clinical trial is accepting participants at present. Initially documented on January 15th 2021, the data was last refreshed on September 25th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Patient-Centered Communication in Breast Cancer Through Patient and Provider Interventions

2021. "Improving Patient-Centered Communication in Breast Cancer Through Patient and Provider Interventions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04549571.

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