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Behavioural Intervention
Internet-Based App for Breast Cancer Treatment Adherence
N/A
Recruiting
Led By Deepthi Kodali, MBBS
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18
Early-stage hormone receptor positive, HER2-negative breast cancer who have completed all recommended (neo)adjuvant chemotherapy, surgery and/or radiation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is looking at whether an internet-based app can help improve adherence to a cancer treatment regimen.
Who is the study for?
This trial is for adults over 18 with early-stage hormone receptor-positive, HER2-negative breast cancer who've finished recommended treatments and started on aromatase inhibitors or Tamoxifen within the last six months. Participants need internet access and must speak English.Check my eligibility
What is being tested?
The study tests a web-based app designed to help patients stick to their endocrine therapy. It includes features like medication reminders, educational videos about side effect management, and direct contact with healthcare providers.See study design
What are the potential side effects?
While not directly related to the app intervention being tested, endocrine therapy can cause joint pain, hot flashes, fatigue, mood changes, and decreased bone density among other potential side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have early-stage, hormone receptor positive, HER2-negative breast cancer and have completed all recommended treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility (Acceptability)
Feasibility (Compliance)
Secondary outcome measures
Adherence
Patient satisfaction
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single Arm (internet intervention, best practice)Experimental Treatment4 Interventions
Patients receive access to the app in addition to standard of care for 3 months. Through the app, patients receive weekly reminders about hormone therapy, report any side effects, access educational videos that provide tips to help mitigate some of these side effects, and allow patients to send messages to members of our breast cancer team about any questions patients may have about the side effects they may be experiencing.
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,638 Previous Clinical Trials
2,560,502 Total Patients Enrolled
28 Trials studying Breast Cancer
3,028 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,926,043 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Deepthi Kodali, MBBSPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is HER2 positive.I started taking an aromatase inhibitor or Tamoxifen less than 6 months ago.I am 18 years old or older.I have early-stage, hormone receptor positive, HER2-negative breast cancer and have completed all recommended treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm (internet intervention, best practice)
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.
Is there currently an opportunity for participants to join this experiment?
"According to the details on clinicaltrials.gov, this study is not recruiting patients at present; it was originally posted and last updated in early 2023. Despite that, there are presently 4576 other medical experiments searching for volunteers."
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