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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 3 weeks
Awards & highlights
No Placebo-Only Group
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.
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.
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 ~ 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Patient Power: Active Patient Participation
Patient Power: Self-efficacy in Patient Physician Interactions
Secondary study objectives
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%
Hip fracture
1%
Breast cancer
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
13,906 Previous Clinical Trials
41,011,396 Total Patients Enrolled
Alliance for Clinical Trials in OncologyLead Sponsor
516 Previous Clinical Trials
220,294 Total Patients Enrolled
Agency for Healthcare Research and Quality (AHRQ)FED
406 Previous Clinical Trials
6,756,539 Total Patients Enrolled
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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.
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