What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as chemotherapy and endocrine therapy, have a range of side effects. Chemotherapy can cause alopecia (hair loss), nausea, vomiting, fatigue, and increased risk of infections due to lowered white blood cell counts. Endocrine therapies, like tamoxifen and aromatase inhibitors, often lead to hot flashes, night sweats, vaginal dryness, and an increased risk of osteoporosis and cardiovascular issues. These side effects can significantly impact the quality of life, contributing to worry, distress, and anxiety among patients.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that align with the goals of managing worry, distress, and anxiety. These include hormonal therapies such as tamoxifen and aromatase inhibitors (e.g., anastrozole, letrozole, and exemestane), which are used to treat hormone receptor-positive breast cancer. Targeted therapies like trastuzumab and pertuzumab are approved for HER2-positive breast cancer. Additionally, CDK4/6 inhibitors (e.g., palbociclib, ribociclib, and abemaciclib) are used in combination with hormonal therapies for advanced breast cancer. These treatments, along with supportive tools like the Enhanced iCanDecide Tool, aim to improve patient outcomes and quality of life by addressing both the physical and emotional aspects of breast cancer care.

What other types of research exist?

Promising, novel alternatives to the Enhanced iCanDecide Tool for managing worry, distress, and anxiety in breast cancer patients include the AMEERA-5 study, which evaluates the combination of amcenestrant and palbociclib for ER+/HER2- advanced breast cancer, and interventions aimed at improving patient-centered communication and decision-making about breast cancer treatment. These interventions focus on enhancing the quality of life and addressing ongoing issues or concerns through a clinician dashboard that populates information after patients view supportive websites.

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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

Must not have

Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 4-5 weeks post patient randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial studies an improved online tool and a doctor dashboard to help breast cancer patients make better treatment decisions and reduce their anxiety.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

Select...

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.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am capable of making my own health decisions.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient knowledge about risks and benefits of local regional treatment

Secondary study objectives

Patient cancer worry

Patient self-efficacy in dealing with breast cancer

Side effects data

From 2013 Phase 3 trial • 4312 Patients • NCT00011986

95%

Neutropenia

87%

Leukopenia

59%

Anemia

49%

Gastrointestinal

42%

Constitutional

37%

Thrombocytopenia

37%

Pain

24%

Peripheral neurologic

19%

Other Hemotologic

16%

Infection/Fever

14%

Neurologic

14%

Metabolic

12%

Pulmonary

2nd Primary

Allergy

Dermatologic

Musculoskeletal

Cardiovascular

Ocular/Visual

Hepatic

Genitourinary/Renal

Endocrine

Auditory

Hemorrhage

Thrombosis/Embolism

Constipation

Syncope

Vomiting

Abdominal Pain Or Cramping

Infection Documented W Grd 3/4 Neutropn.

Ileus

Febrile Neutropenia-Fuo Infect Not Docum

Coagulation

Allergy-Other

Allergic Reaction/Hypersensitivity

Infection Without Neutropenia

100%

80%

60%

40%

20%

Study treatment Arm

Carbo/Taxol

Carbo/Taxol/Gemcitabine

Carbo/Taxol/Doxil

Carbo/Topotecan - Carbo/Taxol

Carbo/Gemcitabine - Carbo/Taxol

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~9890

0 / 5Eligibility criteria met

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.