PACHA Program for Breast Cancer

(PACHA Trial)

Recruiting at 1 trial location

Overseen By Julie Lapointe, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CHU de Quebec-Universite Laval

Must be taking: Adjuvant endocrine therapy

Disqualifiers: Residential facility, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program designed to help women adhere to their hormone therapy after breast cancer. The PACHA Program offers additional support from pharmacists and provides useful information to make medication management easier. The trial aims to determine if this program improves treatment adherence and if it can be easily implemented in more locations. Women who began hormone therapy for hormone-sensitive breast cancer within the last six months and can speak French may be suitable candidates for this trial. As an unphased trial, it offers participants a unique opportunity to contribute to innovative support strategies that could benefit many women in the future.

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 prior data suggests that the PACHA program is safe for women having an adjuvant endocrine therapy?

Research has shown that the PACHA program aims to enhance the experience of women undergoing hormone therapy after breast cancer treatment. This program includes community pharmacists trained to assist women in using this therapy effectively.

In terms of safety, the PACHA program does not introduce new drugs or medical procedures. It focuses on providing support and resources through pharmacies, meaning it does not add any risks beyond those of standard hormone therapy, which is already approved and widely used.

The program's goal is to help women adhere to their therapy and potentially reduce any side effects. It is designed to make the therapy process easier and more manageable, aiding women in staying on their treatment plan. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PACHA program for breast cancer because it focuses on integrating pharmacists directly into the care team, which is not typical in standard treatments like surgery, chemotherapy, and radiation. This program emphasizes personalized care by involving pharmacists to optimize medication management and provide education to patients, potentially improving adherence and outcomes. By enhancing the support system around patients, the PACHA program aims to make treatment more effective and improve the overall experience for women battling breast cancer.

What evidence suggests that the PACHA program is effective for improving AET adherence in women with hormone-sensitive breast cancer?

Research has shown that the PACHA program aims to assist women undergoing hormone therapy for hormone-sensitive breast cancer. In this trial, participants in the PACHA program group will receive resources and training through local pharmacies to support adherence to their treatment. Although direct evidence of its effectiveness is not yet available, the program is expected to enhance treatment management, potentially improving the overall experience for women. Early studies suggest that if successful, the program could enhance support for breast cancer patients and possibly lessen the disease's impact. Success would lead to better outcomes for women on hormone therapy. ^{1 2 3 4 6}

Who Is on the Research Team?

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

Principal Investigator

Laval University

Michel Dorval, Ph.D.

Principal Investigator

Laval University

Line Guénette, Ph.D.

Principal Investigator

Laval University

Jason Guertin, Ph.D.

Principal Investigator

Laval University

Laurence Guillaumie, 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

Benoît Masse, Ph.D.

Principal Investigator

St. Justine's Hospital

Hermann Nabi, Ph.D.

Principal Investigator

Laval University

Louise Provencher, MD

Principal Investigator

CHU de Québec-Université Laval

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Preparation

Pharmacists receive 85 minutes of web-based training to prepare for the PACHA program delivery.

1-2 weeks

Web-based training sessions

Intervention

Pharmacists provide consultations using the PACHA program, including motivational interviewing and resources for AET adherence.

6 months

Consultations at 1 month and 4 months, or more frequently as needed

Follow-up

Participants are monitored for program acceptability and feasibility, and quality of life changes.

6 months

Questionnaires at baseline and end of follow-up

What Are the Treatments Tested in This Trial?

Interventions

• PACHA Program

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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 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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12261619/

protocol for a pilot cluster-randomized controlled trial The goal of this pilot study is to assess the acceptability and feasibility of implementation, and preliminary effects of the PACHA program.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40660375/

protocol for a pilot cluster-randomized controlled trial If effective, this program could fill a gap in breast cancer supportive care and contribute to reducing cancer burden by improving survivorship ...

3. researchgate.net researchgate.net/publication/393684001_A_community_pharmacy-based_program_to_enhance_adherence_to_adjuvant_endocrine_therapy_among_breast_cancer_survivors_PACHA_protocol_for_a_pilot_cluster-randomized_controlled_trial

protocol for a pilot cluster-randomized controlled trial The goal of this pilot study is to assess the acceptability and feasibility of implementation, and preliminary effects of the PACHA program, a community ...

4. semanticscholar.org semanticscholar.org/paper/A-community-pharmacy-based-program-to-enhance-to-a-Lapointe-Guillaumie/c8a7aec94b3ed5cba482f66acf9e46f5d9dd1fd0

[PDF] A community pharmacy-based program to enhance ... If effective, this program could fill a gap in breast cancer supportive care and contribute to reducing cancer burden by improving survivorship experience ...

5. nejm.org nejm.org/doi/abs/10.1056/NEJMoa052122

Trastuzumab plus Adjuvant Chemotherapy for Operable ... Trastuzumab combined with paclitaxel after doxorubicin and cyclophosphamide improves outcomes among women with surgically removed HER2-positive breast cancer.

6. ascopubs.org ascopubs.org/doi/10.1200/EDBK-25-473384

Side Effects of New and Emerging Breast Cancer Therapies Safety data from the SOLAR-1 trial documented rash in 35.6% of patients, which was reflected by a retrospective analysis of more than 100 ...