Pilot Study of PACHA Program to Enhance Adherence to Adjuvant Endocrine Therapy Among Breast Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCHU de Quebec-Universite Laval
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Practicing in a pharmacy in the province of Quebec
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
PACHA Program
BehavioralPharmacists 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.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: PACHA program groupExperimental treatment 1 intervention
Group B: Usual care groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline and 6-month post-randomisation2
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
Time frame
Baseline and 6-month post-randomisation3
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
Time frame
Baseline and 6-month post-randomisation4
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
Time frame
Baseline and 6-month post-randomisationSecondary outcomes
1
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
Time frame
From Baseline to 5 years post-randomisation2
Proportion of women having an AET
Measured by a questionnaire developed by our team and analysis of AET dispensing collected via pharmacy records
Time frame
From Baseline to 5 years post-randomisation3
Mean change from baseline to the end of 6-month follow-up in quality of life
Measured by the Short-Form-12 (SF-12) questionnaire
Time frame
From Baseline to 6-month post-randomisation4
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).
Time frame
At the end of 6-month follow-up (post-randomisation)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
CHU de Quebec-Universite Laval
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Quebec Breast Cancer Foundation
Collaborator
Source ClinicalTrials.gov