Pilot Study of a Community Pharmacy-Based Program to Enhance Adherence to Adjuvant Endocrine Therapy Among Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Mean change from baseline to the end of 6-month follow-up in intention to adhere to adjuvant endocrine therapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •For women :
- •Live in a residential facility where AET is not self-managed
结局指标
主要结局
Mean change from baseline to the end of 6-month follow-up in intention to adhere to adjuvant endocrine therapy
时间窗: 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 the cognitive representations of medication
时间窗: 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 women who used PACHA tools
时间窗: From Baseline to 6-month post-randomisation
Measured by a questionnaire developed by our team and collected automatically by the study website
Mean change from baseline to the end of 6-month follow-up in adjuvant endocrine therapy knowledge
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
Percentage of pharmacies randomized
时间窗: Baseline
Percentage of pharmacists who used PACHA tools in the intervention group
时间窗: 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
时间窗: Baseline
Percentage
Mean number of interventions dispensed by the pharmacists to the participating women
时间窗: 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 women
时间窗: Baseline
Percentage
Cluster size
时间窗: Baseline
Size
次要结局
- 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)
- Proportion of days covered by an Adjuvant Endocrine Therapy (AET)(From Baseline to 5 years post-randomisation)
- Program Acceptability and Feasibility(At the end of 6-month follow-up (post-randomisation))