PACHA Program for Breast Cancer

(PACHA Trial)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: CHU de Quebec-Universite Laval

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this randomized controlled pilot study is to assess the feasibility, acceptability, and preliminary effects of the PACHA program designed for women having an adjuvant endocrine therapy (AET) after hormone-sensitive breast cancer. PACHA (programme en Pharmacie pour l'ACcompagnement des femmes ayant de l'Hormonothérapie Adjuvante) is a community pharmacy-based program aimed at optimizing the experience of AET and its use. The main questions it aims to answer are : * Does the program have an effect on factors expected to influence AET adherence? * Is the program acceptable? * Is the implementation of the program feasible? * What is the feasibility of procedures for carrying out a full-scale study? Participating community pharmacies will be randomized. Pharmacists working in pharmacies assigned to the PACHA group (33 pharmacies) will receive web-based training and manuals to use during their consultations with women having an AET. Recruited women attending these pharmacies will also have access to information and resources about AET (videos, evidence-based booklet). Pharmacists practicing in pharmacies assigned to the control group (33 pharmacies) will provide usual care.

Do I have to stop taking my current medications for the PACHA Program trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study focuses on optimizing the use of adjuvant endocrine therapy (AET), it is likely that you will continue taking your AET medication.

What data supports the idea that PACHA Program for Breast Cancer is an effective treatment?

The available research shows that the PACHA Program, a computer-assisted program for breast cancer patients, is effective in helping those who receive chemotherapy after surgery. It has been validated for its clinical value, meaning it has been tested and proven to be beneficial for patients. However, there is no direct comparison to other treatments in the provided information. ^{1 2 3 4 5}

What safety data exists for the PACHA Program for Breast Cancer treatment?

The provided research does not directly mention the PACHA Program for Breast Cancer treatment or its safety data. However, it discusses the general safety monitoring practices for oncology drugs in Japan, such as all-case surveillance studies (ACSS) and patient support programs (PSPs), which are used to detect adverse events. These studies indicate that while ACSS and PSPs contribute to safety monitoring, their impact on revising drug safety information is limited. No specific safety data for the PACHA Program is mentioned. ^{6 7 8 9 10}

Is the PACHA Program for Breast Cancer a promising treatment?

The PACHA Program for Breast Cancer is promising because it aims to improve breast cancer detection and treatment. It focuses on organizing resources and infrastructure to provide high-quality care, which is important for better health outcomes. ^{11 12 13 14 15}

Research Team

Line Guénette, Ph.D.

Principal Investigator

Laval University

Louise Provencher, MD

Principal Investigator

CHU de Québec-Université Laval

Jason Guertin, Ph.D.

Principal Investigator

Laval University

Laurence Guillaumie, Ph.D.

Principal Investigator

Laval University

Anne Dionne, B.Pharm., M.Sc.

Principal Investigator

Laval University

Michel Dorval, Ph.D.

Principal Investigator

Laval University

Lyne Lalonde, Ph.D.

Principal Investigator

Université de Montréal

Julie Lemieux, MD,M.Sc.

Principal Investigator

CHU de Québec-Université Laval

Hermann Nabi, Ph.D.

Principal Investigator

Laval University

Benoît Masse, Ph.D.

Principal Investigator

St. Justine's Hospital

Eligibility Criteria

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.

Inclusion Criteria

For pharmacists practicing in a pharmacy in the province of Quebec

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

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

Exclusion Criteria

I live in a facility where I do not manage my own endocrine therapy.

Treatment Details

Interventions

• PACHA Program (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: PACHA program group Experimental Treatment 1 Intervention

Pharmacists and women in the PACHA program group will receive the PACHA program component's.

Group II: Usual care group Active Control 1 Intervention

Pharmacists and women in the Usual care group will provide/receive usual care.

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

Fondation Cancer du Sein du Québec

Collaborator

Trials

1

Recruited

70+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Quebec Breast Cancer Foundation

Collaborator

Trials

7

Recruited

890+

Findings from Research

A study involving 310 female breast cancer patients demonstrated that those whose chemotherapy regimens aligned with predictions from a computer-assisted program (CAP) had significantly better overall survival compared to those with partially or inconsistently aligned regimens.

Specifically, patients in the group with chemotherapy consistent with CAP predictions (Group A) had a notably improved prognosis, highlighting the clinical value of using CAP to guide adjuvant chemotherapy decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of treatment efficacy of a computer-assisted program for breast cancer patients receiving postoperative adjuvant chemotherapy. Jiang, Y., Huang, XE., Yan, PW., et al.[2019]

The Comprehensive Chemotherapy Assistance Program (CAP) significantly reduced errors in chemotherapy orders, with incorrect dose and agent errors decreasing by 43.9% and 31.6%, respectively, compared to the existing Order Communication System (OCS).

CAP also improved overall efficiency in ordering processes, with significant reductions in regimen defects, drug omissions, and incorrect data input errors by over 70%, demonstrating its superiority in both safety and efficiency for oncology medication orders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of efficiency and safety of the comprehensive Chemotherapy Assistance Program for ordering oncology medications. Cho, E., Kim, HJ., Kim, GM., et al.[2013]

A quality improvement project at Massachusetts General Hospital aimed to reduce the time from breast cancer diagnosis to the start of chemotherapy, targeting a goal of less than 120 days, as many patients were exceeding this timeframe.

The project involved enhancing systems, improving communication among healthcare providers, and increasing staff recruitment, which are essential steps to improve the overall quality of breast cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Massachusetts general hospital: improving patient access to the breast oncology clinic. Lennes, IT., Bloom, M., Bohlen, N., et al.[2019]

A study of 6487 women with lymph node-positive breast cancer found that older patients (65 years and older) experienced worse overall survival due to non-cancer-related deaths, but age did not affect disease-free survival rates.

Both older and younger women benefited similarly from more aggressive chemotherapy regimens, suggesting that age should not prevent healthy older patients from receiving optimal chemotherapy for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant chemotherapy in older and younger women with lymph node-positive breast cancer. Muss, HB., Woolf, S., Berry, D., et al.[2022]

A quality improvement project aimed at enhancing breast cancer treatment was successfully initiated with the participation of all 156 physicians at an academic medical center, highlighting the potential for clinician engagement in such initiatives.

The project focused on improving the delivery of effective treatments for early-stage breast cancer, indicating a commitment to enhancing patient care in this critical area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging clinicians in a quality improvement strategy for early-stage breast cancer treatment. Bickell, NA., Aufses, AH., Chassin, M.[2019]

A review of all-case surveillance studies (ACSS) for oncology drugs in Japan from 2006 to 2015 revealed that most revisions to drug package inserts regarding serious adverse events were primarily based on spontaneous reports from clinicians rather than ACSS data.

The findings suggest that ACSS may not significantly contribute to updating package inserts, indicating a need for a more efficient system for reporting adverse events that could reduce the burden on the pharmaceutical industry and clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Industry-Conducted All-Case Surveillance of Newly Approved Oncology Drugs Contribute to the Revision of Package Inserts in Japan? Suzuki, A., Sato, H., Sasaki, Y.[2020]

Adverse event reports from patient support programs (PSPs) were less effective and slower at detecting safety signals compared to reports from non-PSP sources, indicating potential limitations in using PSP data for pharmacovigilance.

Among PSPs, those providing clinical services showed slightly better signal detection performance than those that did not, but the difference was not significant in terms of speed, highlighting the need for careful evaluation of PSP data in safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of adverse event reports from marketing authorization holder-sponsored patient support programs on the performance of signal detection in pharmacovigilance. Lee, I., Lee, TA., Crawford, SY., et al.[2021]

In Japan, from 1999 to 2019, 277 out of 1871 approved drugs (14.8%) required postmarketing all-case surveillance (PACS) to monitor safety, with the number of such drugs increasing annually, peaking at 37 drugs in 2018.

Among 87 PACS-requiring drugs reexamined, all were found to maintain their approval status, indicating their continued usefulness, while safety measures were implemented for 53 drugs, highlighting the effectiveness of PACS in ensuring drug safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postmarketing all-case surveillance trends and contribution to safety measures of drugs approved in Japan: a cross-sectional survey in 1999-2019. Nakao, M., Nakamura, Y., Shimokawa, M., et al.[2023]

A study involving 267,473 women diagnosed with breast cancer showed that advanced prediction models, particularly gradient boosted trees (GBT), can effectively predict short-term treatment-related adverse events (AEs) with high sensitivity (96%).

The GBT model outperformed others with an area under the curve of 0.91, indicating strong predictive capability, which could help in developing proactive strategies to manage side effects of breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of a Clinically Guided Data-Driven Approach for Predicting Breast Cancer Complications: An Application Using a Population-Based Claims Data Set. Pichardo, D., Michael, R., Mercer, M., et al.[2023]

In a study of 703 Japanese women who underwent breast-conserving surgery and radiation therapy, common late adverse events included breast pain, fibrosis, and pneumonitis, with serious complications (Grade 2 or 3) occurring in only 3.8% of patients.

The cosmetic outcomes were favorable, with 69.1% of patients reporting excellent or good results, indicating that the treatment is effective not only in managing cancer but also in preserving breast appearance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter investigation of late adverse events in Japanese women treated with breast-conserving surgery plus conventional fractionated whole-breast radiation therapy. Nozaki, M., Kagami, Y., Mitsumori, M., et al.[2022]

Breast cancer incidence in Mexico is rising due to aging populations and increased exposure to risk factors, highlighting the urgent need for improved screening services.

The Mexico Action Program for Breast Cancer Screening and Control (2007-2012) aims to enhance the infrastructure for a National Program focused on the detection, diagnosis, and treatment of breast cancer, ensuring high-quality care that respects patient rights.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Public policies for the detection of breast cancer in Mexico]. Martínez-Montañez, OG., Uribe-Zúñiga, P., Hernández-Avila, M.[2019]

In the last 15 years, five Latin American countries (Argentina, Brazil, Colombia, Mexico, and Venezuela) have recognized breast cancer as a priority issue, with varying degrees of success in implementing national policies for early detection and treatment.

Brazil and Mexico have established comprehensive national policies for breast cancer, while Argentina, Colombia, and Venezuela are still developing their strategies, highlighting the importance of resource allocation and stakeholder involvement in addressing this health crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer policy in Latin America: account of achievements and challenges in five countries. Nigenda, G., Gonzalez-Robledo, MC., Gonzalez-Robledo, LM., et al.[2023]

Early detection programs for breast cancer in middle resource countries (MRCs) are crucial and should include clinical breast examinations and awareness initiatives, but face challenges like financial and logistical barriers.

Access to comprehensive cancer treatment services is limited by geographical and economic factors, highlighting the need for improved health insurance coverage and government funding to enhance early detection and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer management in middle-resource countries (MRCs): consensus statement from the Breast Health Global Initiative. Yip, CH., Cazap, E., Anderson, BO., et al.[2011]

A study involving 29 young breast cancer patients in Mexico revealed significant unmet needs for information regarding their diagnosis, treatment, and side effects, particularly related to fertility and sexuality.

Patients expressed a desire for more empathetic and personalized communication from their medical teams, including educational materials to help them better understand and recall information discussed during appointments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical and information needs among young women with breast cancer in Mexico. Villarreal-Garza, C., López-Martínez, EA., Martínez-Cannon, BA., et al.[2020]

A scoping review of 20 studies revealed that several Latin American countries have implemented policies and programs aimed at preventing and controlling breast cancer, focusing on risk communication, timely detection, and access to health services.

Despite these efforts, there is a significant need for better evaluation of these programs' effectiveness and greater involvement of civil society in their design and execution to overcome barriers to effective breast cancer prevention and control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Public Policies and Programs for the Prevention and Control of Breast Cancer in Latin American Women: Scoping Review. Ramos Herrera, IM., Lemus Flores, MG., Reyna Sevilla, A., et al.[2022]

References

1. Thailand pubmed.ncbi.nlm.nih.gov

Validation of treatment efficacy of a computer-assisted program for breast cancer patients receiving postoperative adjuvant chemotherapy. [2019]

2. Ireland pubmed.ncbi.nlm.nih.gov

Assessment of efficiency and safety of the comprehensive Chemotherapy Assistance Program for ordering oncology medications. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Massachusetts general hospital: improving patient access to the breast oncology clinic. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Adjuvant chemotherapy in older and younger women with lymph node-positive breast cancer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Engaging clinicians in a quality improvement strategy for early-stage breast cancer treatment. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Does Industry-Conducted All-Case Surveillance of Newly Approved Oncology Drugs Contribute to the Revision of Package Inserts in Japan? [2020]

7. England pubmed.ncbi.nlm.nih.gov

Impact of adverse event reports from marketing authorization holder-sponsored patient support programs on the performance of signal detection in pharmacovigilance. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Postmarketing all-case surveillance trends and contribution to safety measures of drugs approved in Japan: a cross-sectional survey in 1999-2019. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Utility of a Clinically Guided Data-Driven Approach for Predicting Breast Cancer Complications: An Application Using a Population-Based Claims Data Set. [2023]

10. England pubmed.ncbi.nlm.nih.gov

A multicenter investigation of late adverse events in Japanese women treated with breast-conserving surgery plus conventional fractionated whole-breast radiation therapy. [2022]

11. Mexico pubmed.ncbi.nlm.nih.gov

[Public policies for the detection of breast cancer in Mexico]. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Breast cancer policy in Latin America: account of achievements and challenges in five countries. [2023]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Breast cancer management in middle-resource countries (MRCs): consensus statement from the Breast Health Global Initiative. [2011]

14. England pubmed.ncbi.nlm.nih.gov

Medical and information needs among young women with breast cancer in Mexico. [2020]

15. Canada pubmed.ncbi.nlm.nih.gov

Public Policies and Programs for the Prevention and Control of Breast Cancer in Latin American Women: Scoping Review. [2022]