Adjuvant endocrine therapy for breast cancer patients: impact of a health system outreach program to improve adherence.
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ABSTRACT: Purpose
Reports suggest that up to 50% of women with hormone receptor-positive (HR+) breast cancer (BC) do not complete the recommended 5 years of adjuvant endocrine therapy (AET). We examined the impact of an outreach program at Kaiser Permanente Northern California (KPNC) on adherence and discontinuation of AET among patients who initiated AET.Methods
We assembled a retrospective cohort of all KPNC patients diagnosed with HR+, stage I-III BC initiating AET before (n?=?4287) and after (n?=?3580) implementation of the outreach program. We compared adherence proportions and discontinuation rates before and after program implementation, both crude and adjusted for age, race/ethnicity, education, income, and stage. We conducted a pooled analysis of data from six Cancer Research Network (CRN) sites that had not implemented programs for improving AET adherence, using identical methods and time periods, to assess possible secular trends.Results
In the pre-outreach period, estimated adherence in years 1, 2, and 3 following AET initiation was 75.2%, 71.0%, and 67.3%; following the outreach program, the estimates were 79.4%, 75.6%, and 72.2% (p-values?ConclusionAdherence and discontinuation after AET initiation improved modestly following implementation of the outreach program.
SUBMITTER: Lee C
PROVIDER: S-EPMC7035197 | biostudies-literature | 2020 Feb
REPOSITORIES: biostudies-literature
Publications
Adjuvant endocrine therapy for breast cancer patients: impact of a health system outreach program to improve adherence.
Lee Catherine C Check Devon K DK Manace Brenman Leslie L Kushi Lawrence H LH Epstein Mara M MM Neslund-Dudas Christine C Pawloski Pamala A PA Achacoso Ninah N Laurent Cecile C Fehrenbacher Louis L Habel Laurel A LA
Breast cancer research and treatment 20200123 1
<h4>Purpose</h4>Reports suggest that up to 50% of women with hormone receptor-positive (HR+) breast cancer (BC) do not complete the recommended 5 years of adjuvant endocrine therapy (AET). We examined the impact of an outreach program at Kaiser Permanente Northern California (KPNC) on adherence and discontinuation of AET among patients who initiated AET.<h4>Methods</h4>We assembled a retrospective cohort of all KPNC patients diagnosed with HR+, stage I-III BC initiating AET before (n = 4287) and ...[more]
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Project description:Adjuvant endocrine therapy (AET) is used to prevent recurrence and reduce mortality for women with hormone receptor positive breast cancer. Poor adherence to AET is a significant problem and contributes to increased medical costs and mortality. A variety of problematic symptoms associated with AET are related to non-adherence and early discontinuation of treatment. The goal of this study is to test a novel, telephone-based coping skills training that teaches patients adherence skills and techniques for coping with problematic symptoms (CST-AET). Adherence to AET will be assessed in real-time for 18 months using wireless smart pill bottles. Symptom interference (i.e., pain, vasomotor symptoms, sleep problems, vaginal dryness) and cost-effectiveness of the intervention protocol will be examined as secondary outcomes. Participants (N = 400) will be recruited from a tertiary care medical center or community clinics in medically underserved or rural areas. Participants will be randomized to receive CST-AET or a general health education intervention (comparison condition). CST-AET includes ten nurse-delivered calls delivered over 6 months. CST-AET provides systematic training in coping skills for managing symptoms that interfere with adherence. Interactive voice messaging provides reinforcement for skills use and adherence that is tailored based on real-time adherence data from the wireless smart pill bottles. Given the high rates of non-adherence and recent recommendations that women remain on AET for 10 years, we describe a timely trial. If effective, the CST-AET protocol may not only reduce the burden of AET use but also lead to cost-effective changes in clinical care and improve breast cancer outcomes. Trials registration: ClinicalTrials.gov, NCT02707471, registered 3/3/2016.
| S-EPMC6346744 | biostudies-literature
Project description:BackgroundWhile adjuvant endocrine therapy (AET) for early-stage, hormone-sensitive breast cancer confers a 40-50% reduction in recurrence risk, adherence to AET is suboptimal, and no efficacious interventions exist to improve adherence. A qualitative study was conducted to understand patient experiences on AET, motivators and barriers to adherence, side effects, and distress, with the goal of developing a patient-centered, evidence-based intervention.MethodFrom November 2017 to November 2018, female patients with early-stage, hormone receptor-positive breast cancer taking AET were recruited. Patients with low and high medication adherence of varying ages, levels of distress, and years taking AET were purposefully enrolled. In-depth semi-structured interviews were conducted, audio recorded, and transcribed. Study staff created a thematic framework, and three independent researchers coded interviews using NVivo 11, achieving high inter-coder agreement (Kappa = .96).ResultsThirty interviews were conducted with patients who were, on average, 55.13 years old (SD = 12.37) and had been taking AET for a mean of 1.76 years (SD = 0.75). The sample was stratified by adherence level (low = 20; high = 10). Recurrent themes related to adherence included a commitment to AET to prevent recurrence despite distressing side effects, lack of strategies to cope with symptoms and distress, and desire for emotional support from others taking AET. Patients were highly accepting of a proposed psychosocial intervention to manage AET.ConclusionPatients are committed to taking AET to prevent breast cancer recurrence, but need and desire psychosocial support and skills training. Themes from this study are modifiable targets for a psychosocial, evidence-based intervention to promote adherence, coping with side effects, and distress management.
| S-EPMC7657969 | biostudies-literature
Project description:BackgroundIn oestrogen-receptor positive breast cancer, daily oral adjuvant endocrine therapy (ET) for at least 5 years significantly reduces risks of recurrence and breast cancer-specific mortality. However, many women are poorly adherent to ET. Development of effective adherence support requires comprehensive understanding of influences on adherence. We undertook an umbrella review to identify determinants of ET adherence.MethodsWe searched PubMed, Embase, CINAHL, PsycINFO, Cochrane and PROSPERO (inception to 08/2022) to identify systematic reviews on factors influencing ET adherence. Abstracted determinants were mapped to the World Health Organization's dimensions of adherence. Reviews were quality appraised and overlap assessed.ResultsOf 5732 citations screened, 17 reviews were eligible (9 quantitative primary studies; 4 qualitative primary studies; 4 qualitative or quantitative studies) including 215 primary papers. All five WHO dimensions influenced ET non-adherence: The most consistently identified non-adherence determinants were patient-related factors (e.g. lower perceived ET necessity, more treatment concerns, perceptions of ET 'cons' vs. 'pros'). Healthcare system/healthcare professional-related factors (e.g. perceived lower quality health professional interaction/relationship) were also important and, to a somewhat lesser extent, socio-economic factors (e.g. lower levels of social/economic/material support). Evidence was more mixed for medication-related and condition-related factors, but several may be relevant (e.g. experiencing side-effects, cost). Potentially modifiable factors are more influential than non-modifiable/fixed factors (e.g. patient characteristics).ConclusionsThe evidence-base on ET adherence determinants is extensive. Future empirical studies should focus on less well-researched areas and settings. The determinants themselves are numerous and complex in indicating that adherence support should be multifaceted, addressing multiple determinants.
| S-EPMC10905548 | biostudies-literature
Project description:PurposeTo inform intervention development, we measured the modifiable determinants of endocrine therapy (ET) non-adherence in women with breast cancer, using the Theoretical Domains Framework (TDF) and examined inter-relationships between these determinants and non-adherence using the Perceptions and Practicalities Approach (PAPA).MethodsWomen with stages I-III breast cancer prescribed ET were identified from the National Cancer Registry Ireland (N = 2423) and invited to complete a questionnaire. A theoretically based model of non-adherence was developed using PAPA to examine inter-relationships between the 14 TDF domains of behaviour change and self-reported non-adherence. Structural equation modelling (SEM) was used to test the model.ResultsA total of 1606 women participated (response rate = 66%) of whom 395 (25%) were non-adherent. The final SEM with three mediating latent variables (LVs) (PAPA Perceptions: TDF domains, Beliefs about Capabilities, Beliefs about Consequences; PAPA Practicalities: TDF domain, Memory, Attention, Decision Processes and Environment) and four independent LVs (PAPA Perceptions: Illness intrusiveness; PAPA Practicalities: TDF domains, Knowledge, Behaviour Regulation; PAPA External Factors: TDF domain, Social Identity) explained 59% of the variance in non-adherence and had an acceptable fit (χ2(334) = 1002, p < 0.001; RMSEA = 0.03; CFI = 0.96 and SRMR = 0.07) Knowledge had a significant mediating effect on non-adherence through Beliefs about Consequences and Beliefs about Capabilities. Illness intrusiveness had a significant mediating effect on non-adherence through Beliefs about Consequences. Beliefs about Consequences had a significant mediating effect on non-adherence through Memory, Attention, Decision Processesg and Environment.ConclusionsBy underpinning future interventions, this model has the potential to improve ET adherence and, hence, reduce recurrence and improve survival in breast cancer.
| S-EPMC9985562 | biostudies-literature
Project description:BACKGROUND:In the Suppression of Ovarian Function Trial (SOFT) and the Tamoxifen and Exemestane Trial (TEXT), the 5-year rates of recurrence of breast cancer were significantly lower among premenopausal women who received the aromatase inhibitor exemestane plus ovarian suppression than among those who received tamoxifen plus ovarian suppression. The addition of ovarian suppression to tamoxifen did not result in significantly lower recurrence rates than those with tamoxifen alone. Here, we report the updated results from the two trials. METHODS:Premenopausal women were randomly assigned to receive 5 years of tamoxifen, tamoxifen plus ovarian suppression, or exemestane plus ovarian suppression in SOFT and to receive tamoxifen plus ovarian suppression or exemestane plus ovarian suppression in TEXT. Randomization was stratified according to the receipt of chemotherapy. RESULTS:In SOFT, the 8-year disease-free survival rate was 78.9% with tamoxifen alone, 83.2% with tamoxifen plus ovarian suppression, and 85.9% with exemestane plus ovarian suppression (P=0.009 for tamoxifen alone vs. tamoxifen plus ovarian suppression). The 8-year rate of overall survival was 91.5% with tamoxifen alone, 93.3% with tamoxifen plus ovarian suppression, and 92.1% with exemestane plus ovarian suppression (P=0.01 for tamoxifen alone vs. tamoxifen plus ovarian suppression); among the women who remained premenopausal after chemotherapy, the rates were 85.1%, 89.4%, and 87.2%, respectively. Among the women with cancers that were negative for HER2 who received chemotherapy, the 8-year rate of distant recurrence with exemestane plus ovarian suppression was lower than the rate with tamoxifen plus ovarian suppression (by 7.0 percentage points in SOFT and by 5.0 percentage points in TEXT). Grade 3 or higher adverse events were reported in 24.6% of the tamoxifen-alone group, 31.0% of the tamoxifen-ovarian suppression group, and 32.3% of the exemestane-ovarian suppression group. CONCLUSIONS:Among premenopausal women with breast cancer, the addition of ovarian suppression to tamoxifen resulted in significantly higher 8-year rates of both disease-free and overall survival than tamoxifen alone. The use of exemestane plus ovarian suppression resulted in even higher rates of freedom from recurrence. The frequency of adverse events was higher in the two groups that received ovarian suppression than in the tamoxifen-alone group. (Funded by Pfizer and others; SOFT and TEXT ClinicalTrials.gov numbers, NCT00066690 and NCT00066703 , respectively.).
| S-EPMC6193457 | biostudies-literature
Project description:Adjuvant endocrine therapy reduces the risk of recurrence and death from breast cancer in women with hormone receptor-positive early breast cancer.Tamoxifen has been the standard therapy for decades, and this is still the case for pre-menopausal women.Ovarian suppression is of similar efficacy but currently there is no strong evidence for adding this to tamoxifen and the additional morbidity can be considerable. Results from two important trials addressing this issueare imminent. In post-menopausal women, aromatase inhibitors (AIs) (letrozole, anastrozole, or exemestane)are superior to tamoxifen in preventing recurrence but only letrozole has been shown to improve survival. The main gain is against high-risk cancers, and tamoxifen gives very similar benefit for low-risk disease. Traditionally, treatment has been given for around 5 years, but many women remain at risk of relapse for 10 years or more.The AIs, and more recently tamoxifen, have been shown to reduce further the risk of late recurrence in women still in remission after 5 years of tamoxifen if given for a further 5 years. The comparative benefits of these two options and the selection of patients most likely to benefit from long-term adjuvant endocrine therapy are important topics for further research, as is the optimum duration of AI therapy started upfront.
| S-EPMC4053079 | biostudies-literature
Project description:Adjuvant endocrine therapy (AET) reduces risk of breast cancer recurrence. However, suboptimal adherence and persistence to AET remain important clinical issues. Understanding factors associated with adherence may help inform efforts to improve use of AET as prescribed. The present systematic review examined potentially modifiable factors associated with adherence to AET in accordance with PRISMA guidelines (PROSPERO registration ID: CRD42019124200). All studies were included, whether factors were significantly associated with adherence or results were null. This review also accounted for the frequency with which a potentially modifiable factor was examined and whether univariate or multivariate models were used. This review also examined whether methodological or sample characteristics were associated with the likelihood of a factor being associated with AET adherence. A total of 68 articles were included. Potentially modifiable factors were grouped into six categories: side effects, attitudes toward AET, psychological factors, healthcare provider-related factors, sociocultural factors, and general/quality of life factors. Side effects were less likely to be associated with adherence in studies with retrospective or cross-sectional than prospective designs. Self-efficacy (psychological factor) and positive decisional balance (attitude toward AET) were the only potentially modifiable factors examined ≥10 times and associated with adherence or persistence ≥75% of the time in both univariate and multivariate models. Self-efficacy and decisional balance (i.e., weight of pros vs. cons) were the potentially modifiable factors most consistently associated with adherence, and hence may be worth focusing on as targets for interventions to improve AET adherence among breast cancer survivors.
| S-EPMC7794693 | biostudies-literature
Project description:PURPOSE:We evaluated associations between personal and clinical social support and non-adherence to adjuvant endocrine therapy (AET) in a large, Northern California breast cancer (BC) cohort from an integrated healthcare network. METHODS:This study included 3382 women from the Pathways Study diagnosed from 2005 to 2013 with stages I-III hormone receptor-positive BC and who responded to the Medical Outcomes Study Social Support and Interpersonal Processes of Care surveys, approximately 2 months post-diagnosis. We used logistic regression to evaluate associations between tertiles of social support and non-initiation (<?2 consecutive prescription fills within a year after diagnosis). Among those who initiated treatment, we used proportional hazards regression to evaluate associations with discontinuation (??90 day gap) and non-adherence (<?80% medical possession ratio). RESULTS:Of those who initiated AET (79%), approximately one-fourth either discontinued AET or were non-adherent. AET non-initiation was more likely in women with moderate (adjusted OR 1.18, 95% CI 0.96-1.46) or low (OR 1.30, 95% CI 1.05-1.62) versus high personal social support (P trend?=?0.02). Women with moderate (HR 1.20, 95% CI 0.99-1.45) or low (HR 1.32, 95% CI 1.09-1.60) personal social support were also more likely to discontinue treatment (P trend?=?0.01). Furthermore, women with moderate (HR 1.25, 95% CI 1.02-1.53) or low (HR 1.38, 95% CI 1.12-1.70) personal social support had higher non-adherence (P trend?=?0.007). Associations with clinical social support and outcomes were similar. Notably, high clinical social support mitigated the risk of discontinuation when patients' personal support was moderate or low (P value?=?0.04). CONCLUSIONS:Women with low personal or clinical social support had higher AET non-adherence. Clinician teams may need to fill support gaps that compromise treatment adherence.
| S-EPMC6026067 | biostudies-literature
Project description:BackgroundAdjuvant endocrine therapy (AET) significantly decreases the risk of breast cancer recurrence and mortality. Notwithstanding the demonstrated efficacy of AET, 31-73% of breast cancer survivors do not persist with AET. The purpose of this study was to explore breast cancer survivors' experiences and perspectives of persisting with AET and to identify the psychosocial and healthcare system factors that influence AET persistence.MethodsInformed by interpretive descriptive methodology and relational autonomy theory, individual interviews were conducted with 22 women diagnosed with early-stage breast cancer who had been prescribed AET. These participants also completed a demographic form and a survey that assessed their perceived risk of recurrence. Interviews were analysed using inductive thematic and constant comparative analysis to iteratively compare data and develop conceptualizations of the relationships among data. Descriptive statistics were used to summarize the quantitative data.ResultsThe personal, social, and structural factors found to influence AET persistence included AET side effects, perception of breast cancer recurrence risk, medication and necessity beliefs, social support, the patient-provider relationship, and the continuity and frequency of follow-up care. For most women, over time, the decision-making process around AET persistence became a balancing act between quality of life and quantity of life. The interplay between the personal, social, and structural factors was complex and the weight women placed on some factors over others influenced their AET persistence or non-persistence.ConclusionExpanding our understanding of the factors affecting breast cancer survivors' AET persistence from their perspective is the first step in developing efficacious, patient-centered interventions aimed at improving AET persistence. In order to improve AET persistence, enhanced symptom management is required, as well as the development of supportive care strategies that acknowledge the values and beliefs held by breast cancer survivors while reinforcing the benefits of AET, and addressing women's reasons for non-persistence. Improved continuity of health care and patient-healthcare provider communication across oncology and primary care settings is also required. The development and evaluation of supportive care strategies that address the challenges associated with AET experienced by breast cancer survivors hold the potential to increase both women's quality and quantity of life.
| S-EPMC6042363 | biostudies-literature
Project description:BackgroundLong-term use of adjuvant endocrine therapy (AET) among women with early-stage, hormone receptor-positive breast cancer significantly reduces the risk of hospitalizations, cancer recurrence, and mortality. AET is associated with adverse symptoms that often result in poor adherence. A web-enabled app offers a novel way to communicate and manage symptoms for women on AET. In a region with significant racial disparities in breast cancer outcomes, our study tests the impact of a web-enabled app that collects and transmits patient-reported symptoms to healthcare teams to facilitate timely and responsive symptom management on medication adherence.MethodsIn this randomized controlled trial, we randomize 300 patients initiating AET to one of three arms: 1) an "App" group (n = 100) that receives weekly reminders to use the THRIVE study app; 2) an "App+Feedback" group (n = 100) that receives weekly reminders and tailored feedback based on their use of the app; or 3) a "Usual Care" group (n = 100) that receives usual care only. Participants are stratified by race: 50% White and 50% Black. The duration of the intervention is six months following enrollment, and outcomes are assessed at 12-months. The primary outcome is adherence, which is captured using an electronic monitoring pillbox. Secondary outcomes include symptom burden, quality of life, self-efficacy for managing symptoms, and healthcare costs. We also evaluate the impact of the intervention on racial disparities in adherence. Data are derived from three sources: electronic health record data to capture treatment changes, healthcare utilization, and health outcomes; self-report survey data related to adherence, symptom burden, and quality of life; and an electronic medication monitoring device that captures adherence.DiscussionA successful web-enabled intervention could be disseminated across systems, conditions, and populations. By evaluating the impact of this intervention on a comprehensive set of measures, including AET adherence, patient outcomes, and costs, our study will provide valuable and actionable results for providers, policy makers, and insurers who strive to achieve the "Triple Aim" - reduce costs while improving health outcomes and the patient care experience.Trial registrationNCT03592771. Prospectively registered on July 19, 2018.
| S-EPMC6924011 | biostudies-literature