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PACHA Program for Breast Cancer (PACHA Trial)
N/A
Recruiting
Research Sponsored by CHU de Quebec-Universite Laval
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Were diagnosed with a first non-metastatic, hormone-sensitive breast cancer
At least one women has initiated adjuvant endocrine therapy (AET) in the last 6 months in the pharmacy
Must not have
For women living in a residential facility where AET is not self-managed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 5 years post-randomisation
Awards & highlights
No Placebo-Only Group
Summary
This trial will assess how a community pharmacy-based program impacts adherence and experience of women having AET after hormone-sensitive breast cancer.
Who is the study for?
This trial is for women over 18 in Quebec, Canada who have started adjuvant endocrine therapy (AET) for the first time within the last 6 months after being diagnosed with non-metastatic, hormone-sensitive breast cancer. Participants must be fluent in French, have internet access, and agree to stay with their current pharmacy throughout the study.
What is being tested?
The PACHA program is being tested to see if it helps women stick to their AET after breast cancer. It's a community pharmacy-based support system that includes web training for pharmacists and resources like videos and booklets for patients. The study will compare pharmacies using PACHA against those providing usual care.
What are the potential side effects?
Since this trial focuses on adherence support rather than a medical intervention, there are no direct side effects from drugs or treatments involved. However, participants may experience varying levels of satisfaction or psychological impact from the additional support.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My first breast cancer was non-spreading and responsive to hormones.
Select...
I started hormone therapy for cancer in the last 6 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I live in a facility where I do not manage my own endocrine therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 5 years post-randomisation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 5 years post-randomisation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cluster size
Mean change from baseline to the end of 6-month follow-up in adjuvant endocrine therapy knowledge
Mean change from baseline to the end of 6-month follow-up in anticipated regret
+13 moreSecondary study objectives
Mean change from baseline to the end of 6-month follow-up in quality of life
Program Acceptability and Feasibility
Proportion of days covered by an Adjuvant Endocrine Therapy (AET)
+1 moreAwards & 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: PACHA program groupExperimental Treatment1 Intervention
Pharmacists and women in the PACHA program group will receive the PACHA program component's.
Group II: Usual care groupActive Control1 Intervention
Pharmacists and women in the Usual care group will provide/receive usual care.
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Who is running the clinical trial?
Fondation Cancer du Sein du QuébecUNKNOWN
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,385 Previous Clinical Trials
26,515,869 Total Patients Enrolled
Quebec Breast Cancer FoundationOTHER
6 Previous Clinical Trials
826 Total Patients Enrolled
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