Pilot randomized controlled trial of a program to enhance experience and adherence with adjuvant endocrine therapy among women with non-metastatic breast cancer: 12-month quantitative results.

PURPOSE: Adjuvant endocrine therapy (AET) reduces recurrence risk after hormone receptor-positive breast cancer, but non-adherence is common. We pilot-tested SOIE, a program to enhance AET experience and adherence, to assess its acceptability, feasibility, and effects on psychosocial precursors of AET adherence. METHODS: We conducted a 12-month pilot randomized controlled trial among women who had a first AET prescription. Intervention group received SOIE while control group received usual care. Psychosocial factors from the Theory of Planned Behavior (TPB) (intention - primary outcome -, attitude, subjective norm, behavioral control), additional constructs (AET knowledge, social support, coping planning), impact of AET services received, and adherence were measured by questionnaires at baseline, 3-month, and 12-month endpoints. Group patterns were compared using repeated measures analyses with generalized estimating equations. RESULTS: A total of 106 women were randomized (participation = 54.9%; intervention n = 52; control n = 54; retention = 93.8%). Among SOIE women, ≥ 90% received the program components and were satisfied. Both groups scored high on adherence intentions and group patterns over time were not statistically different. In the intervention group, AET knowledge and coping planning with side effects increased (group-by-time p-value = .002 and .016), a higher proportion reported that AET services received helped them take their AET (p < .05) and have a consistent daily intake (p = .01). CONCLUSION: SOIE is feasible and acceptable for survivors with an AET. SOIE did not significantly impact adherence intentions but was beneficial for other program outcomes and daily intake. IMPLICATIONS FOR CANCER SURVIVORS: SOIE may represent an encouraging avenue to enhance supportive care and empower survivors with managing AET.

Incorporating a learning unit on vaccine hesitancy into a first-year doctor of pharmacy immunization course.

INTRODUCTION: Vaccine hesitancy is a growing threat to public health. The objective of this research was to investigate the effect of incorporating a learning unit on addressing vaccine hesitancy into a doctor of pharmacy immunization delivery course. METHODS: The learning unit, implemented fall 2019 at the University of Rhode Island, involved two interactive lectures and an at-home assignment. A family medicine physician spoke about her experiences with vaccine-hesitant families, and students viewed video scenarios depicting a pharmacist talking with vaccine-hesitant patients followed by an in-class discussion. Data was collected using pre- and post-surveys and a one-year follow-up survey. RESULTS: Out of 125 students enrolled in the course, 121 completed the pre-survey, 113 the post-survey, and 120 the follow-up survey. For pre-/post-survey comparison questions, statistically significant improvements were seen in 9 of 13 items. The follow-up survey showed 83.4% of students had applied knowledge and 85.7% had applied skills gained from the learning unit. CONCLUSION: Incorporating a learning unit on addressing vaccine hesitancy into a pharmacy immunization class resulted in improvements in student self-reported knowledge and comfort in talking with patients who are vaccine hesitant. Long-term use of self-reported knowledge and skills gained was seen one-year post-implementation.

Development of a community pharmacy-based intervention to enhance adherence to adjuvant endocrine therapy among breast cancer survivors guided by the Intervention Mapping approach.

BACKGROUND: Adjuvant endocrine therapy (AET) is prescribed for 5 or 10 years to women with non-metastatic breast cancer to reduce recurrence and mortality risks. However, AET adherence is suboptimal for many women. The few interventions specifically designed to enhance AET adherence and evaluated to date have provided inconclusive results. None of these interventions was offered in the community pharmacy setting. OBJECTIVE: To describe the development of the PAcHA program, a community pharmacy-based intervention aiming to enhance AET adherence. METHODS: The development of the intervention was guided by the six-step Intervention Mapping approach: needs assessment (Step 1); development of objectives matrices (Step 2); selection of theory-based intervention methods and practical applications (Step 3); development of the intervention program (Step 4); development of the adoption and implementation plan (Step 5); and evaluation plan (Step 6). Researchers, pharmacists and women prescribed AET were consulted at key steps. RESULTS: The logic model was developed based on women's needs identified through a literature review and a qualitative study (Step 1). Optimal use of treatment for each woman with a new AET prescription was considered the behavioral outcome of the intervention. A woman is expected to: acquire knowledge about AET; make an informed decision about AET initiation and persistence; respect administration modalities and cope with side effects (Step 2). Motivational interviewing principles serve to guide the pharmacist intervention (Step 3). The intervention is brief and tailored to AET initiation and follow-up visits. Standardized intervention tools are available as support for pharmacists in their counseling (Step 4). An implementation plan was established, and web-based training was designed to train the pharmacists (Step 5). A cluster-randomized controlled trial was designed to evaluate the intervention (Step 6). CONCLUSION: The systematic approach used for developing the intervention may increase its potential for being efficiently implemented and effective.

Women's Beliefs on Early Adherence to Adjuvant Endocrine Therapy for Breast Cancer: A Theory-Based Qualitative Study to Guide the Development of Community Pharmacist Interventions.

Adjuvant endocrine therapy (AET) taken for a minimum of five years reduces the recurrence and mortality risks among women with hormone-sensitive breast cancer. However, adherence to AET is suboptimal. To guide the development of theory-based interventions to enhance AET adherence, we conducted a study to explore beliefs regarding early adherence to AET. This qualitative study was guided by the Theory of Planned Behavior (TPB). We conducted focus groups and individual interviews among women prescribed AET in the last two years (n = 43). The topic guide explored attitudinal (perceived advantages and disadvantages), normative (perception of approval or disapproval), and control beliefs (barriers and facilitating factors) towards adhering to AET. Thematic analysis was conducted. Most women had a positive attitude towards AET regardless of their medication-taking behavior. The principal perceived advantage was protection against a recurrence while the principal inconvenience was side effects. Almost everyone approved of the woman taking her medication. The women mentioned facilitating factors to encourage medication-taking behaviors and cope with side effects. For adherent women, having trouble establishing a routine was their main barrier to taking medication. For non-adherent women, it was side effects affecting their quality of life. These findings could inform the development of community pharmacy-based adherence interventions.

Pharmacological and non-hormonal treatment of hot flashes in breast cancer survivors: CEPO review and recommendations.

PURPOSE: Breast cancer patients frequently report hot flashes. Given that conventional hormone replacement therapy is generally contraindicated for them, other therapeutic modalities must be considered. The purpose of this review was to develop evidence-based recommendations on non-hormonal pharmacological interventions, including natural health products, for managing hot flashes in women undergoing treatment for breast cancer or with a history of breast cancer. METHODS: A review of the scientific literature published between January 2000 and December 2011 was performed. A total of 26 randomized trials were identified. RESULTS: Studies showed that serotonin-norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors, antihypertensives and anticonvulsants significantly reduced the frequency and severity of hot flashes in breast cancer patients. CONCLUSIONS: Considering the evidence available to date, the CEPO recommends the following: (1) for breast cancer patients being treated with tamoxifen: (a) the use of venlafaxine, citalopram, clonidine, gabapentin and pregabalin be considered effective in treating hot flashes and (b) the use of paroxetine and fluoxetine be avoided, given that they may reduce the efficacy of tamoxifen; (2) for breast cancer patients not being treated with tamoxifen: (a) the use of venlafaxine, paroxetine, citalopram, clonidine, gabapentin and pregabalin be considered effective in treating hot flashes and (b) fluoxetine not be used to treat hot flashes, given that there is insufficient evidence for its therapeutic efficacy and (3) for breast cancer survivors, sertraline, phytoestrogens, black cohosh and St. John's wort not be used to treat hot flashes.