Breast NeoplasmsPACHANCT05887102
Pilot Study of PACHA Program to Enhance Adherence to Adjuvant Endocrine Therapy Among Breast Cancer Survivors
A study testing PACHA Program in people with Breast Neoplasms and Breast Cancer, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Breast Cancer
- What is being tested?
- PACHA Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteCanada
- Study dates
- 7 Jun 2023to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- For women :
- Live in a residential facility where AET is not self-managed
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre de recherche du CHU de Québec
Québec, Quebec, G1S 4L8
Julie Lapointe, Ph.D., 418-682-7511 ext. 84556, etudepacha@crchudequebec.ulaval.ca
About this study
Official 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.
Read the detailed description
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).
The PACHA program consists, for the pharmacists, of:
- A 85-minutes web-based training to prepare the pharmacists for delivery of the intervention. The program comprises three main sections led by experts: 1) a review of AET pharmacotherapy; 2) information on AET consultation based on the principles of motivational interviewing and video simulations of AET consultations according to program tools and expert feedback of these simulations, and 3) access to materials geared to participating women (web-video capsules about AET, self-management strategies for coping with specific AET side effects and list of resources). The web-based training can be completed in one or more sessions. Pharmacists who complete the program will receive continuing education credits. The PACHA pharmacists will have to complete this program in the weeks after randomization.
- Standardized consultation guide based on motivational interviewing to guide AET consultations (by phone or in person). This standardized consultation guide outlines the key steps that the pharmacist must cover during the AET consultation and follows the usual sequence of consultation in pharmacy. This consultation guide is to be used in the first month and 4 months after randomization, or more frequently according to a woman's situation.
- Evidence-based web sheets describing (non)pharmacological strategies to cope with side effects (e.g. hot flashes) and other AET-related concerns (e.g. sexuality) and to guide the consultation.
For the women, the PACHA program consists of:
- Web video capsules to inform women about AET. These video capsules cover how to and why take tamoxifen or an aromatase inhibitor, the possible side effects and strategies to cope with these side effects and, finally, medication intake and daily activities (e.g. diet). This also includes testimonies of women who had breast cancer and an AET.
- Evidence-based web sheets describing (non)pharmacological strategies to cope with side effects (e.g. hot flashes) and other AET-related concerns (e.g. sexuality) in a version adapted for the woman.
- List of web resources available for women to help cope with side effects and other AET-related concerns.
Participation in the study will take place over a period of 6 months. The study will be carried out in approximately 66 pharmacies in the Quebec province (33 will be assigned to the control group and 33 to the intervention group), which include approximately 132 women (66 in the control group and 66 in the intervention group). At the end of the follow-up, pharmacists and women in the control group can, if desired, receive certain tools offered in the intervention group.
Pharmacists and participating women will be asked to completed two questionnaires: the first before randomization and the second at the end of the follow-up 6 months later.
At the end of the study, 20-30 pharmacists and 20-30 patients will be invited to take part in a semi-directed individual interview (qualitative component) in order to gather their point of view and their experience with the care and services received in relation to AET.
The characteristics of pharmacies, pharmacists and patients in the intervention and control groups will be compared. Indicators of acceptability and feasibility will be measured (e.g. recruitment and participation and retention rates). Generalized Estimating Equation (GEE) regression models will be used to compare patterns of changes in scores of factors expected to influence AET experience and adherence in the two groups and between study entry and 6 months later. The main analyzes will be performed on a intention-to-treat basis. For the qualitative component, a thematic analysis will be carried out based on the transcriptions of the semi-structured interviews. The quantitative and qualitative results will be used to optimize the PACHA program, its implementation and to design, if the results support this, a large-scale randomized controlled trial.
- Conditions
- Breast Neoplasms, Breast Cancer
- Being tested
- PACHA Program
- Keywords
- Breast Cancer, Adjuvant Endocrine Therapy, Adherence to Treatment, Community Pharmacy, Support, Survivorship, Intervention Evaluation, Pilot Study, Randomized Controlled Trial, Feasibility Study, Mixed-Methods
- Medical subject headings
- Breast Neoplasms, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACHA ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PACHA program group | Experimental | Pharmacists and women in the PACHA program group will receive the PACHA program component's. Receives: Behavioral: PACHA Program |
| Usual care group | No intervention | Pharmacists and women in the Usual care group will provide/receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From Baseline to 6-month post-randomisation
Percentage of eligible and enrolled pharmacists
Percentage
Measured: Baseline
Percentage of eligible and enrolled women
Percentage
Measured: Baseline
Percentage of pharmacies randomized
Measured: Baseline
Cluster size
Size
Measured: Baseline
Secondary outcomes (4)
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
Measured: From Baseline to 5 years post-randomisation
Proportion of women having an AET
Measured by a questionnaire developed by our team and analysis of AET dispensing collected via pharmacy records
Measured: From Baseline to 5 years post-randomisation
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
Measured: From Baseline to 6-month post-randomisation
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).
Measured: At the end of 6-month follow-up (post-randomisation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start7 Jun 2023
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Quebec Breast Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Anne Dionne, B.Pharm., M.Sc., Study director, Laval UniversityMichel Dorval, Ph.D., Study director, Laval UniversityLine Guénette, Ph.D., Study director, Laval UniversityJason Guertin, Ph.D., Study director, Laval UniversityLaurence Guillaumie, Ph.D., Study director, Laval UniversityLyne Lalonde, Ph.D., Study director, Université de MontréalJulie Lemieux, MD,M.Sc., Study director, CHU de Québec-Université LavalBenoît Masse, Ph.D., Study director, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887102
- Sponsor's protocol ID
- number CIHR 420809
- Acronym
- PACHA
- Status last verified
- Aug 2024
- First submitted
- 24 May 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40660375
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Community Pharmacy-Based Program to Enhance Adherence to Adjuvant Endocrine Therapy Among Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05887102
- Acronym / sponsor ID
- PACHA / number CIHR 420809
- Conditions
- Breast Neoplasms, Breast Cancer
- Keywords
- Breast Cancer, Adjuvant Endocrine Therapy, Adherence to Treatment, Community Pharmacy, Support, Survivorship, Intervention Evaluation, Pilot Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Quebec Breast Cancer Foundation
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
The PACHA program consists, for the pharmacists, of:
- A 85-minutes web-based training to prepare the pharmacists for delivery of the intervention. The program comprises three main sections led by experts: 1) a review of AET pharmacotherapy; 2) information on AET consultation based on the principles of motivational interviewing and video simulations of AET consultations according to program tools and expert feedback of these simulations, and 3) access to materials geared to participating women (web-video capsules about AET, self-management strategies for coping with specific AET side effects and list of resources). The web-based training can be completed in one or more sessions. Pharmacists who complete the program will receive continuing education credits. The PACHA pharmacists will have to complete this program in the weeks after randomization.
- Standardized consultation guide based on motivational interviewing to guide AET consultations (by phone or in person). This standardized consultation guide outlines the key steps that the pharmacist must cover during the AET consultation and follows the usual sequence of consultation in pharmacy. This consultation guide is to be used in the first month and 4 months after randomization, or more frequently according to a woman's situation.
- Evidence-based web sheets describing (non)pharmacological strategies to cope with side effects (e.g. hot flashes) and other AET-related concerns (e.g. sexuality) and to guide the consultation.
For the women, the PACHA program consists of:
- Web video capsules to inform women about AET. These video capsules cover how to and why take tamoxifen or an aromatase inhibitor, the possible side effects and strategies to cope with these side effects and, finally, medication intake and daily activities (e.g. diet). This also includes testimonies of women who had breast cancer and an AET.
- Evidence-based web sheets describing (non)pharmacological strategies to cope with side effects (e.g. hot flashes) and other AET-related concerns (e.g. sexuality) in a version adapted for the woman.
- List of web resources available for women to help cope with side effects and other AET-related concerns.
Participation in the study will take place over a period of 6 months. The study will be carried out in approximately 66 pharmacies in the Quebec province (33 will be assigned to the control group and 33 to the intervention group), which include approximately 132 women (66 in the control group and 66 in the intervention group). At the end of the follow-up, pharmacists and women in the control group can, if desired, receive certain tools offered in the intervention group.
Pharmacists and participating women will be asked to completed two questionnaires: the first before randomization and the second at the end of the follow-up 6 months later.
At the end of the study, 20-30 pharmacists and 20-30 patients will be invited to take part in a semi-directed individual interview (qualitative component) in order to gather their point of view and their experience with the care and services received in relation to AET.
The characteristics of pharmacies, pharmacists and patients in the intervention and control groups will be compared. Indicators of acceptability and feasibility will be measured (e.g. recruitment and participation and retention rates). Generalized Estimating Equation (GEE) regression models will be used to compare patterns of changes in scores of factors expected to influence AET experience and adherence in the two groups and between study entry and 6 months later. The main analyzes will be performed on a intention-to-treat basis. For the qualitative component, a thematic analysis will be carried out based on the transcriptions of the semi-structured interviews. The quantitative and qualitative results will be used to optimize the PACHA program, its implementation and to design, if the results support this, a large-scale randomized controlled trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| PACHA program group | Experimental | Behavioral: PACHA ProgramPharmacists and women in the PACHA program group will receive the PACHA program component's. |
| Usual care group | No intervention | –Pharmacists and women in the Usual care group will provide/receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
- Provide consent
Key exclusion criteria (2 listed)
- Live in a residential facility where AET is not self-managed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PACHA ProgramPharmacists 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. | Behavioural | PACHA program group |
Primary outcome
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
Measured by a questionnaire developed and validated by our team (4 items, score range: 1-7), higher score means higher intention to adhere
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
Measured by a questionnaire developed and validated by our team (17 items, score range: 0-17), higher score means higher level of knowledge
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
Measured by a questionnaire developed and validated by our team (4 items, score range: 1-7), higher score means more positive attitude
Mean change from baseline to the end of 6-month follow-up in perceived social support
Time frame: Baseline and 6-month post-randomisation
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
Mean change from baseline to the end of 6-month follow-up in perceived behavioural control
Time frame: Baseline and 6-month post-randomisation
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
Mean change from baseline to the end of 6-month follow-up in anticipated regret
Time frame: Baseline and 6-month post-randomisation
Measured by a questionnaire developed and validated by our team (6 items, score range: 1-7), higher score means higher level of anticipated regret
Mean change from baseline to the end of 6-month follow-up in coping planning
Time frame: Baseline and 6-month post-randomisation
Measured by a questionnaire developed and validated by our team (6 items, score range: 1-7), higher score means higher level of coping planning
Mean change from baseline to the end of 6-month follow-up in fear of recurrence
Time frame: Baseline and 6-month post-randomisation
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
Mean change from baseline to the end of 6-month follow-up in side effects
Time frame: Baseline and 6-month post-randomisation
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
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
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
Percentage of pharmacists who used PACHA tools in the intervention group
Time frame: From Baseline to 6-month post-randomisation
Measured by a questionnaire developed by our team and collected automatically by the study website
Percentage of women who used PACHA tools
Time frame: From Baseline to 6-month post-randomisation
Measured by a questionnaire developed by our team and collected automatically by the study website
Mean number of interventions dispensed by the pharmacists to the participating women
Time frame: From Baseline to 6-month post-randomisation
Measured by a questionnaire developed by our team and collected automatically by the study website
Percentage of eligible and enrolled pharmacists
Time frame: Baseline
Percentage
Percentage of eligible and enrolled women
Time frame: Baseline
Percentage
Percentage of pharmacies randomized
Time frame: Baseline
Cluster size
Time frame: Baseline
Size
4 secondary outcomes
Proportion of days covered by an Adjuvant Endocrine Therapy (AET)
Time frame: From Baseline to 5 years post-randomisation
Proportion of women having an AET
Time frame: From Baseline to 5 years post-randomisation
Mean change from baseline to the end of 6-month follow-up in quality of life
Time frame: From Baseline to 6-month post-randomisation
Program Acceptability and Feasibility
Time frame: At the end of 6-month follow-up (post-randomisation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Derived from this study: PubMed 40660375Lapointe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Dionne, B.Pharm., M.Sc. study director
Laval University
Michel Dorval, Ph.D. study director
Laval University
Line Guénette, Ph.D. study director
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PACHA Program in people with Breast Neoplasms and Breast Cancer, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie Lauzier, Ph.D. (418-682-7547 ext. 87547, sophie.lauzier@crchudequebec.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05887102, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.