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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 5 years post-randomisation

Awards & highlights

PACHA Trial 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.Check my eligibility

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.See study design

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.

PACHA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My first breast cancer was non-spreading and responsive to hormones.

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I started hormone therapy for cancer in the last 6 months.

PACHA Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 5 years post-randomisation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

+14 more

Secondary outcome measures

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 more

PACHA 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fondation Cancer du Sein du QuébecUNKNOWN

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,501 Total Patients Enrolled

10 Trials studying Breast Cancer

4,704 Patients Enrolled for Breast Cancer

Quebec Breast Cancer FoundationOTHER

6 Previous Clinical Trials

826 Total Patients Enrolled

5 Trials studying Breast Cancer

728 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum number of participants accepted for this medical research?

"Affirmative. According to clinicaltrials.gov, the mentioned trial was first advertised on June 7th 2023 and has been recently revised on September 8th 2023. 66 patients have to be enrolled from one medical facility for this investigation."

Answered by AI

Is enrollment for this experiment available to participants at the moment?

"The clinical trial is currently in the process of recruiting patients, according to information posted on clinicaltrials.gov. This study was initially listed on June 7th 2023 and has been updated as recently as September 8th 2023."

Answered by AI

What is the primary purpose of this clinical research?

"The primary objective of the trial, which is evaluated over a baseline and 6-month postrandomisation period, is to measure the percentage of qualified women enrolled in the study. Secondary goals include gauging program acceptability and feasibility through interviews conducted with pharmacists and participants (in intervention group only), assessing how many women receive adjuvant endocrine therapy via questionnaire data and pharmacy records analysis, as well as calculating the proportion of days covered by this treatment based on similar methods."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pilot Study of PACHA Program to Enhance Adherence to Adjuvant Endocrine Therapy Among Breast Cancer Survivors

2023. "Pilot Study of PACHA Program to Enhance Adherence to Adjuvant Endocrine Therapy Among Breast Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05887102.

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