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

Summary

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.

Conditions

• Breast Neoplasms
• Breast Cancer

Interventions

BEHAVIORAL

PACHA Program

Pharmacists in this group will complete the 85-minutes web-based training, schedule and realize at least 2 telephone consultations with participating women in their pharmacy (in the first month and 4 months after randomization) using standardized consultation guides based on the principles of motivational interviewing and, if necessary, the evidence-based web sheets about strategies to cope with side effects and other AET-related concerns. Women in this group will have access to a web site that includes video capsules to inform women about AET, evidence-based web sheets describing strategies to cope with side effects and other AET-related concerns, testimonies of women who had breast cancer and an AET and a list of resources available for women.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Quebec Breast Cancer Foundation

  collaborator OTHER

• CHU de Quebec-Universite Laval

  lead OTHER

Principal Investigators

• Anne Dionne, B.Pharm., M.Sc. · Laval University

• Michel Dorval, Ph.D. · Laval University

• Line Guénette, Ph.D. · Laval University

• Jason Guertin, Ph.D. · Laval University

• Laurence Guillaumie, Ph.D. · Laval University

• Lyne Lalonde, Ph.D. · Université de Montréal

• Julie Lemieux, MD,M.Sc. · CHU de Québec-Université Laval

• Benoît Masse, Ph.D. · St. Justine's Hospital

• Hermann Nabi, Ph.D. · Laval University

• Louise Provencher, MD · CHU de Québec-Université Laval

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-07

Primary Completion

2025-03-31

Completion

2025-03-31

Countries

• Canada

Study Locations