Recruiting

PACHA Program

Sponsor:

CHU de Quebec-Universite Laval

Code:

NCT05887102

Conditions

Breast Neoplasms

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PACHA Program

Study Details

Brief 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

Study ID

NCT05887102

Start date

Jun 7, 2023

Status verified date

Aug, 2024

Completion date

Mar, 2025

Anticipated

Primary completion date

Mar, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

For pharmacies :

  • In the province of Quebec, Canada
  • At least one pharmacist agrees to take charge of the project in their pharmacy
  • At least one women has initiated adjuvant endocrine therapy (AET) in the last 6 months in the pharmacy

For pharmacists :

  • Practicing in a pharmacy in the province of Quebec
  • Provide consent

For women :

  • 18 years old or older
  • Were diagnosed with a first non-metastatic, hormone-sensitive breast cancer
  • Received and AET prescription for the first time in the last 6 months
  • Are fluent in French
  • Have internet access
  • Provide consent

Exclusion Criteria:

For women :

• Live in a residential facility where AET is not self-managed

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: PACHA program group

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

no intervention: Usual care group

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

Interventions

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.

Primary outcome measure

  • Mean change from baseline to the end of 6-month follow-up in intention to adhere to adjuvant endocrine therapy [ Time Frame: Baseline and 6-month post-randomisation ]
  • Mean change from baseline to the end of 6-month follow-up in adjuvant endocrine therapy knowledge [ Time Frame: Baseline and 6-month post-randomisation ]
  • Mean change from baseline to the end of 6-month follow-up in attitude towards adjuvant endocrine therapy [ Time Frame: Baseline and 6-month post-randomisation ]
  • Mean change from baseline to the end of 6-month follow-up in perceived social support [ Time Frame: Baseline and 6-month post-randomisation ]
  • Mean change from baseline to the end of 6-month follow-up in perceived behavioural control [ Time Frame: Baseline and 6-month post-randomisation ]
  • Mean change from baseline to the end of 6-month follow-up in anticipated regret [ Time Frame: Baseline and 6-month post-randomisation ]
  • Mean change from baseline to the end of 6-month follow-up in coping planning [ Time Frame: Baseline and 6-month post-randomisation ]
  • Mean change from baseline to the end of 6-month follow-up in fear of recurrence [ Time Frame: Baseline and 6-month post-randomisation ]
  • Mean change from baseline to the end of 6-month follow-up in side effects [ Time Frame: Baseline and 6-month post-randomisation ]
  • Mean change from baseline to the end of 6-month follow-up in the cognitive representations of medication [ Time Frame: Baseline and 6-month post-randomisation ]
  • Percentage of pharmacists who used PACHA tools in the intervention group [ Time Frame: From Baseline to 6-month post-randomisation ]
  • Percentage of women who used PACHA tools [ Time Frame: From Baseline to 6-month post-randomisation ]
  • Mean number of interventions dispensed by the pharmacists to the participating women [ Time Frame: From Baseline to 6-month post-randomisation ]
  • Percentage of eligible and enrolled pharmacists [ Time Frame: Baseline ]
  • Percentage of eligible and enrolled women [ Time Frame: Baseline ]
  • Percentage of pharmacies randomized [ Time Frame: Baseline ]
  • Cluster size [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Sophie Lauzier, Ph.D.

418-682-7547sophie.lauzier@crchudequebec.ulaval.ca

Julie Lapointe, Ph.D.

418-682-7511etudepacha@crchudequebec.ulaval.ca

Locations

Centre de recherche du CHU de Québec

Recruiting

Quebec city, Quebec, Canada, G1S 4L8

Contacts

Julie Lapointe, Ph.D.

418-682-7511etudepacha@crchudequebec.ulaval.ca

More Information

Sponsor

CHU de Quebec-Universite Laval

Last update posted

Aug 22, 2024

Last verified

Aug, 2024

Keywords

  • Breast Cancer
  • Adjuvant Endocrine Therapy
  • Adherence to Treatment
  • Community Pharmacy
  • Support
  • Survivorship
  • Intervention Evaluation
  • Pilot Study
  • Randomized Controlled Trial
  • Feasibility Study
  • Mixed-Methods

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CHU de Quebec-Universite Laval on 2024-08-22.