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Individualized Interventions for Breast Cancer (MyCHOICE Trial)

N/A
Waitlist Available
Led By Shahid Ahmed, MD, PhD
Research Sponsored by University of Saskatchewan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Premenopausal women with histologically-proven, completely resected, hormone receptor-positive (defined as ER≥10% and/or PgR≥10%) stage 1, 2, and 3 invasive breast cancer who are treated with combination of anti-estrogen therapy (LHRH agonist and an aromatase inhibitor or tamoxifen)
Must not have
Post-menopausal women
Women who are on single agent endocrine therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to three years from the time of enrolment
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if interventions can help improve quality of life for women with early stage hormone receptor positive breast cancer.

Who is the study for?
This trial is for premenopausal women with early-stage breast cancer that's hormone receptor-positive and has been surgically removed. Participants must be on a combination of anti-estrogen therapies. Post-menopausal women or those on single agent endocrine therapy cannot join.
What is being tested?
The study tests if tailored behavioral and complementary interventions can improve quality of life and adherence to treatment in young women undergoing combined endocrine therapy for breast cancer, by monitoring changes in their quality of life and treatment adherence.
What are the potential side effects?
While the trial itself focuses on improving tolerance, common side effects from the underlying endocrine treatments may include hot flashes, mood swings, fatigue, bone density loss, joint pain, and sexual dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a premenopausal woman with a certain type of early-stage breast cancer that has been fully removed and am on specific hormone therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am a woman who has gone through menopause.
Select...
I am a woman currently on hormone therapy for cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to three years from time of enrolment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to three years from time of enrolment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Functional Assessment of Cancer Therapy - Breast Symptom Index (FACT-B)
Secondary study objectives
Functional Assessment of Cancer Therapy - (FACT)-Cognitive
Functional Assessment of Cancer Therapy - Endocrine System (FACT-ES)
Treatment discontinuation rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Individualized interventionsExperimental Treatment1 Intervention
Exercise, Yoga, massage therapy, acupuncture, and others
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Individualized interventions
2018
N/A
~50

Find a Location

Who is running the clinical trial?

University of SaskatchewanLead Sponsor
257 Previous Clinical Trials
156,050 Total Patients Enrolled
1 Trials studying Breast Cancer
450 Patients Enrolled for Breast Cancer
Shahid Ahmed, MD, PhDPrincipal InvestigatorUniversity of Saskatchewan
2 Previous Clinical Trials
59 Total Patients Enrolled

Media Library

Individualized interventions Clinical Trial Eligibility Overview. Trial Name: NCT03407768 — N/A
Breast Cancer Research Study Groups: Individualized interventions
Breast Cancer Clinical Trial 2023: Individualized interventions Highlights & Side Effects. Trial Name: NCT03407768 — N/A
Individualized interventions 2023 Treatment Timeline for Medical Study. Trial Name: NCT03407768 — N/A
~6 spots leftby Dec 2025
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