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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.
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I am between 21 and 84 years old.
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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 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
9%
Hepatic
8%
Dermatologic
7%
Cardiovascular
6%
Allergy
6%
Hemorrhage
5%
Genitourinary/Renal
5%
Musculoskeletal
4%
Ocular/Visual
3%
Endocrine
2%
Auditory
2%
Thrombosis/Embolism
1%
Ileus
1%
Infection Documented W Grd 3/4 Neutropn.
1%
Infection Without Neutropenia
1%
Coagulation
1%
Sexual
1%
Platelets
1%
Allergic Reaction/Hypersensitivity
1%
Febrile Neutropenia-Fuo Infect Not Docum
100%
80%
60%
40%
20%
0%
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
~9870

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for breast cancer, particularly hormone receptor-positive types, include endocrine therapies such as aromatase inhibitors (AIs) and selective estrogen receptor modulators (SERMs). Aromatase inhibitors, like letrozole and anastrozole, work by blocking the enzyme aromatase, which converts androgens into estrogens, thereby reducing estrogen levels and slowing the growth of estrogen-dependent cancer cells. SERMs, such as tamoxifen, bind to estrogen receptors on cancer cells, preventing estrogen from binding and promoting cancer cell death. These treatments are crucial as they target the hormonal pathways that fuel certain breast cancers, improving patient outcomes. Tools like the Enhanced iCanDecide help patients navigate these treatment options while managing associated emotional distress, leading to more informed and personalized care decisions.
Promising novel therapies for the treatment of endometrial cancer.Intraperitoneal chemotherapy for the initial management of primary epithelial ovarian cancer.Indications and limitations of third-generation aromatase inhibitors.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,719 Previous Clinical Trials
40,962,833 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,966 Patients Enrolled for Breast Cancer
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
216,926 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
~91 spots leftby Jan 2025
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