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Decision Aid for Breast Cancer Surgery Choices
N/A
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 weeks
Awards & highlights
Study Summary
This trial is testing a breast cancer surgery decision aid to see if it increases patient engagement in decision making, and if there are any barriers to patient engagement.
Who is the study for?
This trial is for English-speaking patients newly diagnosed with stage 0-III breast cancer who are planning surgery as part of their treatment. Surgeons and care staff at participating clinics must consent to the study. Patients with impaired decision-making capacity or hearing impairment requiring an interpreter are excluded.Check my eligibility
What is being tested?
The study compares usual care against a web-based decision aid designed to increase patient engagement in surgical decisions for breast cancer. It also explores barriers to engagement, particularly among socioeconomically disadvantaged patients.See study design
What are the potential side effects?
Since this trial involves a decision aid rather than medication, traditional side effects aren't expected. However, there may be psychological impacts from increased involvement in treatment decisions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient power: active patient participation
Patient power: self-efficacy in patient physician interactions
Secondary outcome measures
Concordance between personal values and surgery received
Patient knowledge
Side effects data
From 2016 Phase 3 trial • 300 Patients • NCT0200856551%
Constipation
9%
Urinary tract infection
6%
Diarrhoea
6%
Headache
5%
Fall
5%
Abdominal distension
5%
Abdominal pain
5%
Upper respiratory tract infection
3%
Nausea
2%
Haemorrhoids
1%
Breast cancer
1%
Hip fracture
1%
Syncope
1%
Medical device removal
1%
Back pain
1%
Animal bite
1%
Suture related complication
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo - Education Only
Loperamide - Exercise Plus Biofeedback
Loperamide - Education Only
Placebo - Exercise Plus Biofeedback
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (web-based breast cancer surgery decision aid)Experimental Treatment2 Interventions
Following a 10 week implementation period, at the time of institutional crossover, participants will receive a web-based decision aid prior to the surgical consultation..
Group II: Arm I (surgical consultation)Active Control1 Intervention
Prior to institutional crossover, participants receive care as per usual care.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,923,891 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
217,040 Total Patients Enrolled
75 Trials studying Breast Cancer
40,143 Patients Enrolled for Breast Cancer
Agency for Healthcare Research and Quality (AHRQ)FED
399 Previous Clinical Trials
6,821,750 Total Patients Enrolled
3 Trials studying Breast Cancer
5,005 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You were recently diagnosed with early-stage breast cancer.Doctors, nurses, assistants, and other healthcare providers who help treat people with newly diagnosed breast cancer at the clinic.Hospitals that do not perform surgery on 120-300 new breast cancer patients each year.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (surgical consultation)
- Group 2: Arm II (web-based breast cancer surgery decision aid)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In which specific locales is this investigation being conducted?
"A total of 10 trial sites are participating, such as John H Stroger Jr Hospital of Cook County in Chicago, Virginia Commonwealth University/Massey Cancer Center in Richmond and Kapiolani Medical Center for Women and Children in Honolulu. The list is supplemented by several other medical centres across the country."
Answered by AI
Are there still slots available for volunteers in this experiment?
"Clinicaltrials.gov details that this trial is no longer accepting candidates, despite being initially posted on March 1st 2019 and last updated October 21 2022. Nonetheless, there are still 2291 other trials currently in the process of recruitment."
Answered by AI
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