NCT05887102

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

June 7, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

1.7 years

First QC Date

May 24, 2023

Last Update Submit

August 20, 2024

Conditions

Breast NeoplasmsBreast Cancer

Keywords

Breast CancerAdjuvant Endocrine TherapyAdherence to TreatmentCommunity PharmacySupportSurvivorshipIntervention EvaluationPilot StudyRandomized Controlled TrialFeasibility StudyMixed-Methods

Outcome Measures

Primary Outcomes (17)

  • Mean change from baseline to the end of 6-month follow-up in intention to adhere to adjuvant endocrine therapy

    Measured by a questionnaire developed and validated by our team (4 items, score range: 1-7), higher score means higher intention to adhere

    Baseline and 6-month post-randomisation

  • Mean change from baseline to the end of 6-month follow-up in adjuvant endocrine therapy knowledge

    Measured by a questionnaire developed and validated by our team (17 items, score range: 0-17), higher score means higher level of knowledge

    Baseline and 6-month post-randomisation

  • Mean change from baseline to the end of 6-month follow-up in attitude towards adjuvant endocrine therapy

    Measured by a questionnaire developed and validated by our team (4 items, score range: 1-7), higher score means more positive attitude

    Baseline and 6-month post-randomisation

  • Mean change from baseline to the end of 6-month follow-up in perceived social support

    Measured by a questionnaire developed and validated by our team (3 items, score range: 1-7), higher score means higher level of perceived social support

    Baseline and 6-month post-randomisation

  • Mean change from baseline to the end of 6-month follow-up in perceived behavioural control

    Measured by a questionnaire developed and validated by our team (4 items, score range: 1-7), higher score means higher level of perceived behavioural control

    Baseline and 6-month post-randomisation

  • Mean change from baseline to the end of 6-month follow-up in anticipated regret

    Measured by a questionnaire developed and validated by our team (6 items, score range: 1-7), higher score means higher level of anticipated regret

    Baseline and 6-month post-randomisation

  • Mean change from baseline to the end of 6-month follow-up in coping planning

    Measured by a questionnaire developed and validated by our team (6 items, score range: 1-7), higher score means higher level of coping planning

    Baseline and 6-month post-randomisation

  • Mean change from baseline to the end of 6-month follow-up in fear of recurrence

    Measured by the Fear of cancer recurrence inventory (FCRI) severity scale (9 items, score range: 0-36), higher score means higher level of fear of recurrence

    Baseline and 6-month post-randomisation

  • Mean change from baseline to the end of 6-month follow-up in side effects

    Measured by the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) questionnaire (19 items, score range: 0-100), higher score means higher level of side effects

    Baseline and 6-month post-randomisation

  • Mean change from baseline to the end of 6-month follow-up in the cognitive representations of medication

    Measured by the Beliefs about Medicines Questionnaire (BMQ) (5 items for specific necessity, 5 items for specific concerns, score range: 5-25, higher score means higher level of necessity or concerns

    Baseline and 6-month post-randomisation

  • Percentage of pharmacists who used PACHA tools in the intervention group

    Measured by a questionnaire developed by our team and collected automatically by the study website

    From Baseline to 6-month post-randomisation

  • Percentage of women who used PACHA tools

    Measured by a questionnaire developed by our team and collected automatically by the study website

    From Baseline to 6-month post-randomisation

  • Mean number of interventions dispensed by the pharmacists to the participating women

    Measured by a questionnaire developed by our team and collected automatically by the study website

    From Baseline to 6-month post-randomisation

  • Percentage of eligible and enrolled pharmacists

    Percentage

    Baseline

  • Percentage of eligible and enrolled women

    Percentage

    Baseline

  • Percentage of pharmacies randomized

    Baseline

  • Cluster size

    Size

    Baseline

Secondary Outcomes (4)

  • Proportion of days covered by an Adjuvant Endocrine Therapy (AET)

    From Baseline to 5 years post-randomisation

  • Proportion of women having an AET

    From Baseline to 5 years post-randomisation

  • Mean change from baseline to the end of 6-month follow-up in quality of life

    From Baseline to 6-month post-randomisation

  • Program Acceptability and Feasibility

    At the end of 6-month follow-up (post-randomisation)

Study Arms (2)

PACHA program group

EXPERIMENTAL

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

Behavioral: PACHA Program

Usual care group

NO INTERVENTION

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

Interventions

PACHA ProgramBEHAVIORAL

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.

PACHA program group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 :
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche du CHU de Québec

Québec, Quebec, G1S 4L8, Canada

RECRUITING

Related Publications (1)

  • Lapointe J, Guillaumie L, Dionne A, Lalonde L, Lemieux J, Dorval M, Nabi H, Lemay M, Guenette L, Guertin JR, Masse B, Lauzier S. 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. Pilot Feasibility Stud. 2025 Jul 14;11(1):98. doi: 10.1186/s40814-025-01676-8.

    PMID: 40660375DERIVED

MeSH Terms

Conditions

Breast NeoplasmsTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesHealth BehaviorBehavior

Study Officials

  • Anne Dionne, B.Pharm., M.Sc.

    Laval University

    STUDY DIRECTOR

  • Michel Dorval, Ph.D.

    Laval University

    STUDY DIRECTOR

  • Line Guénette, Ph.D.

    Laval University

    STUDY DIRECTOR

  • Jason Guertin, Ph.D.

    Laval University

    STUDY DIRECTOR

  • Laurence Guillaumie, Ph.D.

    Laval University

    STUDY DIRECTOR

  • Lyne Lalonde, Ph.D.

    Université de Montréal

    STUDY DIRECTOR

  • Julie Lemieux, MD,M.Sc.

    CHU de Québec-Université Laval

    STUDY DIRECTOR

  • Benoît Masse, Ph.D.

    St. Justine's Hospital

    STUDY DIRECTOR

  • Hermann Nabi, Ph.D.

    Laval University

    STUDY DIRECTOR

  • Louise Provencher, MD

    CHU de Québec-Université Laval

    STUDY DIRECTOR

Central Study Contacts

Sophie Lauzier, Ph.D.

CONTACT

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

Julie Lapointe, Ph.D.

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Pharmacists and women will not be blind to the intervention but analyses of data self-reported by the participants (questionnaires) will be conducted in a blinded fashion.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This is a cluster randomized controlled pilot trial using mixed methods (quantitative and qualitative). A cluster consists of a pharmacy, its pharmacists and its patients with adjuvant endocrine therapy (AET) prescription who have agreed to participate. Participating pharmacies will be randomly assigned to two groups. In the first group, pharmacists will provide usual services to women (control group). In the second group, pharmacist and women will have access to the PACHA program in addition to the usual services (intervention group).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2023

First Posted

June 2, 2023

Study Start

June 7, 2023

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

August 22, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)