Breast Cancer Clinical Trial
— PACHAOfficial title:
Pilot Study of a Community Pharmacy-Based Program to Enhance Adherence to Adjuvant Endocrine Therapy Among Breast Cancer Survivors
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.
Status | Recruiting |
Enrollment | 66 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 - Agree to continue being followed by their current pharmacy for the duration of the study - Have internet access - Provide consent Exclusion Criteria: For women : • Live in a residential facility where AET is not self-managed |
Country | Name | City | State |
---|---|---|---|
Canada | Centre de recherche du CHU de Québec | Quebec city | Quebec |
Lead Sponsor | Collaborator |
---|---|
CHU de Quebec-Universite Laval | Canadian Institutes of Health Research (CIHR), Quebec Breast Cancer Foundation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Mean change from baseline to the end of 6-month follow-up in side effects | Measured by the FACT-ES questionnaire (19 items, score range: 0-100), higher score means higher level of side effects | Baseline and 6-month post-randomisation | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Percentage of eligible and enrolled pharmacists | Percentage | Baseline | |
Primary | Percentage of eligible and enrolled women | Percentage | Baseline | |
Primary | Percentage of pharmacies randomized | Baseline | ||
Primary | Cluster size | Size | Baseline | |
Secondary | Proportion of days covered by an Adjuvant Endocrine Therapy (AET) | Measured by a questionnaire developed by our team and analysis of AET dispensing collected via pharmacy records | From Baseline to 5 years post-randomisation | |
Secondary | Proportion of women having an AET | Measured by a questionnaire developed by our team and analysis of AET dispensing collected via pharmacy records | From Baseline to 5 years post-randomisation | |
Secondary | Mean change from baseline to the end of 6-month follow-up in quality of life | Measured by the SF-12 questionnaire | From Baseline to 6-month post-randomisation | |
Secondary | Program Acceptability and Feasibility | Measured by semi-structured interviews conducted with pharmacists and participating women on the relevance, acceptability and perceived benefits of each program component (intervention group only). | At the end of 6-month follow-up (post-randomisation) |
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