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Behavioural Intervention
E-Health Solutions for Breast Cancer (ABODE Trial)
N/A
Recruiting
Led By Tulin Cil, MD, MEd
Research Sponsored by University Health Network, Toronto
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 6 and 12 months post-diagnosis
Awards & highlights
ABODE Trial Summary
This trial is testing an app to help newly diagnosed breast cancer patients with virtual consultations & education, while tracking their outcomes & experience.
Who is the study for?
This trial is for women diagnosed with early-stage breast cancer who need surgery first. They must be over 18, speak English, have internet access and an email. It's not for those with advanced cancer, scheduled immediate surgery, enrolled in similar studies or with sensory challenges.Check my eligibility
What is being tested?
The ABODE study tests a Breast Cancer Treatment App against standard care. The app offers virtual consultations, educational materials, and tracks patient outcomes. The main goal is to see if the app improves patient engagement over a year.See study design
What are the potential side effects?
Since this trial involves an e-health solution rather than medication, traditional side effects are not applicable. However, users may experience issues related to technology use such as eye strain or stress from technical difficulties.
ABODE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 and 12 months post-diagnosis
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months post-diagnosis
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Objective
Secondary outcome measures
PROM 10: The Duke Activity Status Index (DASI)
PROM 11:The Multidimensional Impact of Cancer Risk Assessment (MICRA)
PROM 12: The Knowgene
+12 moreABODE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Interventional ArmExperimental Treatment1 Intervention
Individuals within the intervention will receive standard care and access to the Breast Cancer Treatment Application (BCTA) for 13 months.
Group II: Control ArmActive Control1 Intervention
The control arm will receive standard treatment.
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,476 Previous Clinical Trials
484,980 Total Patients Enrolled
Tulin Cil, MD, MEdPrincipal InvestigatorUniversity Health Network, Toronto
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer cannot be removed with surgery.I am a woman diagnosed with my first invasive breast cancer.I have hearing or visual challenges.My cancer is at stage 4 or has spread to other parts of my body.I can communicate in English and understand the difference between sex and gender.My breast cancer surgery is scheduled within 5 days of joining the trial.My first treatment for my condition will be surgery.I am 18 years old or older.I am a male, as defined at birth.I have received chemotherapy before surgery.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: Interventional Arm
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently openings for enrolment in this clinical trial?
"The data hosted on clinicaltrials.gov reveals that this medical trial is actively seeking volunteers. It was initially launched on the 22nd of June 2023 with its most recent update occurring on August 9th, 2023."
Answered by AI
What is the capacity of subjects for this medical research?
"Correct. According to the information from clinicaltrials.gov, this medical trial is still enrolling patients since its initial posting on June 22nd 2023 and last update on August 9th 2023. The study necessitates 200 participants across a single site."
Answered by AI
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