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.

What methods are used to study the association between medication adherence trajectories, estimated with the group-based trajectory modeling (GBTM) method, and health-related outcomes?-a protocol for a systematic review.

BACKGROUND: The group-based trajectory modeling (GBTM) method is increasingly used in pharmacoepidemiologic studies to describe medication adherence trajectories over time. However, assessing the associations between these medication adherence trajectories and health-related outcomes remains challenging. The purpose of this review is to identify and systematically review the methods used to assess the association between medication adherence trajectories, estimated from the GBTM method, and health-related outcomes. METHODS: We will conduct a systematic review according to the recommendations of the Cochrane handbook for systematic reviews of interventions 6.2. Results will be reported following PRISMA 2020 (Preferred Reporting Items for Systematic Reviews and Meta-analyses) recommendations. We will search in the following databases: PubMed, Embase, PsycINFO, Web of Science, CINAHL, and Cochrane Library. Two reviewers will independently select articles and extract data. Discrepancies at every step will be resolved through discussion, and consensus will be reached for all disagreed articles. A third reviewer will act as a referee if needed. We will produce tables to synthesize the modalities used to estimate medication adherence trajectories with GBTM. We will also synthesize the modalities used to assess the association between these medication adherence trajectories and health-related outcomes by identifying the types of health-related outcomes studied and how they are defined, the statistical models used, and how the medication adherence trajectories were used in these models, and the effect measure yield. We will also review the limitations and biases reported by the authors and their attempts to mitigate them. We will provide a narrative synthesis. DISCUSSION: This review will provide a thorough exploration of the strategies and methods used in medication adherence research to estimate the associations between medication adherence trajectories, estimated with GBTM, and the different health-related outcomes. It will represent the first crucial steps toward optimizing these methods in adherence studies. SYSTEMATIC REVIEW REGISTRATION: Prospero CRD42021213503 .

Five-Year Adjuvant Endocrine Therapy Adherence Trajectories Among Women With Breast Cancer: A Nationwide French Study Using Administrative Data.

BACKGROUND: Adjuvant endocrine therapy (AET) improves long-term survival of breast cancer patients, yet many women are nonadherent or discontinue this treatment. In this study we aimed to describe AET adherence trajectories over 5 years after treatment initiation and to identify factors associated with these trajectories, in a nationwide French cohort of breast cancer survivors. PATIENTS AND METHODS: Every woman diagnosed with a first nonmetastatic breast cancer in 2011 in France who initiated AET in the 12 months after surgery was included from the French cancer cohort. We identified all reimbursements for AET from national health administrative data sets and modeled AET adherence trajectories over 5 years, using group-based trajectory modeling on the basis of the monthly proportion of days covered by AET. Associated factors were identified using multinomial logistic regressions. RESULTS: We included 33,260 women. A 6-trajectory model was selected: 1, immediate discontinuation (6.6%); 2, continuous suboptimal adherence (4.3%); 3, progressive nonadherence then discontinuation (6.3%); 4, early nonadherence then discontinuation (5.7%); 5, continuous optimal adherence (68.8%); and 6, late nonadherence then discontinuation (8.3%). The main factors associated with nonadherence trajectories were extreme age (younger than 50 and older than 70 years) and switching AET. CONCLUSION: Approximately 70% of women had optimal adherence over all 5 years. The original nationwide approach enabled us to identify the "continuous suboptimal adherence trajectory" never previously described.

The impact of health literacy on medico-social follow-up visits among French cancer survivors 5 years after diagnosis: The national VICAN survey.

BACKGROUND: Long-term medico-social follow-up of cancer survivors is a challenge because of frequent subsequent troubles. In particular survivors with lower health literacy (HL) have poorer health and might more often use primary care services. However, the impact of HL on cancer survivors' medico-social follow-up visits is not known. Our aim was to study medico-social follow-up and its associated determinants with a focus on HL 5 years after diagnosis. METHODS: VICAN is a national survey of French adult cancer survivors 5 years after a primary cancer. The Single-Item Literacy Screener was used to define functional HL in this sample. We also asked patients to report the frequency of follow-up visits with a general practitioner (GP) and/or social worker (SW) regarding their cancer disease. RESULTS: The 4045 participants were 57.4 ± 12.9 years old at diagnosis (range 20-82) and 1495 (37%) were classified as having inadequate HL. Most cancer survivors (66.7%) were followed up by a GP regarding their cancer while only 14.5% had contact with a SW. After adjustment for sociodemographic, medical, and psychosocial characteristics, medico-social follow-ups (GP and SW visits) were more frequent among survivors with low HL. Furthermore, low income, unemployment, impaired mental health, treatment by chemotherapy, and perception of sequelae and fatigue were also associated with more frequent medico-social follow-up. Cancer localization association with medico-social follow-up was heterogeneous. CONCLUSION: French cancer survivors with limited HL, lower socioeconomic status, and more severe cancer were more likely to use GP care and social services. Raising awareness and training GPs and SWs on medico-social follow-up for patients with limited HL seem necessary to support these vulnerable survivors.