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Decision Support Tools for Breast Cancer

N/A

Recruiting

Led By Meghan Karuturi

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Must be a candidate for chemotherapy or targeted therapy (in the setting of HER2+ breast cancer)

Must have been diagnosed with stage I-III breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial is studying a decision tool for older women with early stage breast cancer considering chemotherapy.

Who is the study for?

This trial is for older women aged 65 or above who have been diagnosed with Stage I-III breast cancer and are within 3 months of deciding on neoadjuvant or adjuvant chemotherapy. Participants must be able to read and speak English, have no visual or auditory deficits, and their physician must agree to take part in the study.Check my eligibility

What is being tested?

The study aims to understand decision-making needs of these women by conducting interviews, discussions, and questionnaires. The goal is to create a support tool that helps patients and doctors make informed decisions about chemotherapy treatment options.See study design

What are the potential side effects?

Since this trial involves non-medical interventions like interviews and questionnaires rather than drugs or medical procedures, there are no direct side effects associated with traditional clinical trials.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am eligible for chemotherapy or targeted therapy for my HER2+ breast cancer.

Select...

I was diagnosed with early to locally advanced breast cancer.

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I am a woman aged 65 or older.

Select...

I was diagnosed with early to locally advanced breast cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Decision making needs assessment questionnaire

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ArmExperimental Treatment3 Interventions

Participants in the intervention arm only will then be asked to look at the decision tool that includes educational materials about the diagnosis and treatment of breast cancer. These could be written information, graphics, videos, animations, or questionnaires. This decision tool will personalize the decision to you specifically and support your decision-making process

Group II: Non-Intervention ArmActive Control1 Intervention

Participants undergo interviews and complete questionnaires over 1-2 hours. Patients and physicians also participate in a discussion and complete shared decision-making questionnaire over 15-30 minutes.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,376 Total Patients Enrolled

148 Trials studying Breast Cancer

63,286 Patients Enrolled for Breast Cancer

Meghan KaruturiPrincipal InvestigatorM.D. Anderson Cancer Center

3 Previous Clinical Trials

72 Total Patients Enrolled

Media Library

Intervention Arm Clinical Trial Eligibility Overview. Trial Name: NCT05049746 — N/A

Breast Cancer Research Study Groups: Intervention Arm, Non-Intervention Arm

Breast Cancer Clinical Trial 2023: Intervention Arm Highlights & Side Effects. Trial Name: NCT05049746 — N/A

Intervention Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05049746 — N/A

Frequently Asked Questions

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

Is this research endeavor seeking participants right now?

"Affirmative. The details listed on clinicaltrials.gov demonstrate that this medical trial is actively recruiting volunteers, having first been posted in August 2016 and updated most recently in August 2022. A total of 100 individuals across 1 site are needed for enrolment."

Answered by AI

What is the current enrolment size of this research project?

"Indeed, clinicaltrials.gov confirms that this study is actively enrolling patients. It was first posted on August 23rd 2016 and the most recent update happened last month on August 11th 2022. The trial has a goal of recruiting 100 participants from one centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Identifying Decision Making Needs for Older Adult Women With Stage I-III Breast Cancer Considering Neoadjuvant or Adjuvant Chemotherapy

2016. "Identifying Decision Making Needs for Older Adult Women With Stage I-III Breast Cancer Considering Neoadjuvant or Adjuvant Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05049746.