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.

Women with breast cancer's perceptions of nurse-led telephone-based motivational interviewing consultations to enhance adherence to adjuvant endocrine therapy: a qualitative study.

BACKGROUND: Daily adjuvant endocrine therapy (AET) for 5 or 10 years is the standard of care for women diagnosed with non-metastatic hormone receptor-positive breast cancer. However, many women experience AET-related issues that may hamper quality of life and adherence. Here, we aimed to describe women's perceptions of motivational interviewing (MI)-guided consultations delivered by a trained nurse navigator over the telephone to enhance AET adherence. METHODS: Eighteen women who were first prescribed AET for non-metastatic breast cancer in the last 5 years, who self-reported AET-related issues, and who participated in at least two MI-guided consultations over a year were interviewed about their perceptions of the intervention, using a semi-structured interview guide. Audio recordings were transcribed verbatim and analyzed using a thematic analysis approach. RESULTS: Three main themes emerged from the data about women's perceptions on MI-guided consultations. These consultations were described as (1) a person-centred experience, (2) providing key information about AET, and (3) supportive of present and future AET experience, by contributing to AET side-effect management, motivation, adherence, calming negative emotions, improving well-being and self-esteem, and making women to feel empowered. CONCLUSIONS: Nurse-led telephone-based MI-guided consultations about AET were found to respond to participants' needs and to enhance participants' perceptions of being informed and being supported in experiencing various facets of AET. Telephone-based consultations for AET are perceived as a promising strategy in an increasing virtual care world.

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.

Role of Psychosocial Factors and Health Literacy in Pregnant Women's Intention to Use a Decision Aid for Down Syndrome Screening: A Theory-Based Web Survey.

BACKGROUND: Deciding about undergoing prenatal screening is difficult, as it entails risks, potential loss and regrets, and challenges to personal values. Shared decision making and decision aids (DAs) can help pregnant women give informed and values-based consent or refusal to prenatal screening, but little is known about factors influencing the use of DAs. OBJECTIVE: The objective of this study was to identify the influence of psychosocial factors on pregnant women's intention to use a DA for prenatal screening for Down syndrome (DS). We also added health literacy variables to explore their influence on pregnant women's intention. METHODS: We conducted a survey of pregnant women in the province of Quebec (Canada) using a Web panel. Eligibility criteria included age >18 years, >16 weeks pregnant, low-risk pregnancy, and having decided about prenatal screening for the current pregnancy. We collected data based on an extended version of the Theory of Planned Behavior assessing 7 psychosocial constructs (intention, attitude, anticipated regret, subjective norm, descriptive norm, moral norm, and perceived control), 3 related sets of beliefs (behavioral, normative, and control beliefs), 4 health literacy variables, and sociodemographics. Eligible women watched a video depicting the behavior of interest before completing a Web-based questionnaire. We performed descriptive, bivariate, and ordinal logistic regression analyses. RESULTS: Of the 383 eligible pregnant women who agreed to participate, 350 pregnant women completed the Web-based questionnaire and 346 were retained for analysis (completion rate 350/383, 91.4%; mean age 30.1, SD 4.3, years). In order of importance, factors influencing intention to use a DA for prenatal screening for DS were attitude (odds ratio, OR, 9.16, 95% CI 4.02-20.85), moral norm (OR 7.97, 95% CI 4.49-14.14), descriptive norm (OR 2.83, 95% CI 1.63-4.92), and anticipated regret (OR 2.43, 95% CI 1.71-3.46). Specific attitudinal beliefs significantly related to intention were that using a DA would reassure them (OR 2.55, 95% CI 1.73-4.01), facilitate their reflections with their spouse (OR 1.55, 95% CI 1.05-2.29), and let them know about the advantages of doing or not doing the test (OR 1.53, 95% CI 1.05-2.24). Health literacy did not add to the predictive power of our model (P values range .43-.92). CONCLUSIONS: Implementation interventions targeting the use of a DA for prenatal screening for DS by pregnant women should address a number of modifiable factors, especially by introducing the advantages of using the DA (attitude), informing pregnant women that they might regret not using it (anticipated regret), and presenting the use of DAs as a common practice (descriptive norm). However, interventions on moral norms related to the use of DA should be treated with caution. Further studies that include populations with low health literacy are needed before decisive claims can be made.

Prediction of daily fruit and vegetable consumption among overweight and obese individuals.

The purpose of this study is twofold: to identify the determinants of daily fruit and vegetable (F&V) consumption and the moderators of the intention-behaviour relationship. A sample of 225 overweight or obese adults completed a TPB questionnaire. F&V behaviour was assessed at baseline and three months later. Statistical analyses revealed that past behaviour, perceived behavioural control (PBC) and age were significant predictors of daily F&V consumption. In addition, intention was found to interact with anticipated regret. Interventions should encourage the development of habit and PBC. However, the age and level of anticipated regret of the targeted population should be considered when designing interventions.