Active Treatment Phase Research Articles

Lowering cholesterol, blood pressure, or both to prevent cardiovascular events: results of 8.7 years of follow-up of Heart Outcomes Evaluation Prevention (HOPE)-3 study participants.

AimsRosuvastatin (10 mg per day) compared with placebo reduced major adverse cardiovascular (CV) events by 24% in 12 705 participants at intermediate CV risk after 5.6 years. There was no benefit of blood pressure (BP) lowering treatment in the overall group, but a reduction in events in the third of participants with elevated systolic BP. After cessation of all the trial medications, we examined whether the benefits observed during the active treatment phase were sustained, enhanced, or attenuated.Methods and resultsAfter the randomized treatment period (5.6 years), participants were invited to participate in 3.1 further years of observation (total 8.7 years). The first co-primary outcome for the entire length of follow-up was the composite of myocardial infarction, stroke, or CV death [major adverse cardiovascular event (MACE)-1], and the second was MACE-1 plus resuscitated cardiac arrest, heart failure, or coronary revascularization (MACE-2). In total, 9326 (78%) of 11 994 surviving Heart Outcomes Prevention Evaluation (HOPE)-3 subjects consented to participate in extended follow-up. During 3.1 years of post-trial observation (total follow-up of 8.7 years), participants originally randomized to rosuvastatin compared with placebo had a 20% additional reduction in MACE-1 [95% confidence interval (CI), 0.64–0.99] and a 17% additional reduction in MACE-2 (95% CI 0.68–1.01). Therefore, over the 8.7 years of follow-up, there was a 21% reduction in MACE-1 (95% CI 0.69–0.90, P = 0.005) and 21% reduction in MACE-2 (95% CI 0.69–0.89, P = 0.002). There was no benefit of BP lowering in the overall study either during the active or post-trial observation period, however, a 24% reduction in MACE-1 was observed over 8.7 years.ConclusionThe CV benefits of rosuvastatin, and BP lowering in those with elevated systolic BP, compared with placebo continue to accrue for at least 3 years after cessation of randomized treatment in individuals without cardiovascular disease indicating a legacy effect.Trial Registration NumberNCT00468923

Results of the Optimune trial: A randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors.

IntroductionAfter the acute treatment phase, breast cancer patients often experience low quality of life and impaired mental health, which could potentially be improved by offering cognitive behavioural therapy (CBT) and addressing exercise and dietary habits. However, CBT and other behavioural interventions are rarely available beyond the acute treatment phase. Internet-based interventions could bridge such treatment gaps, given their flexibility and scalability. In this randomized controlled trial (RCT), we investigated the effects of such an intervention (“Optimune”) over three months.MethodsThis RCT included 363 female breast cancer survivors (age range = 30–70), recruited from the community, who had completed the active treatment phase. Inclusion criteria were: breast cancer diagnosis less than 5 years ago and acute treatment completion at least 1 month ago. Participants were randomly assigned to (1) an intervention group (n = 181), in which they received care as usual (CAU) plus 12-month access to Optimune immediately after randomization, or (2) a control group (n = 182), in which they received CAU and Optimune after a delay of 3 months. Primary endpoints were quality of life (QoL), physical activity, and dietary habits at three months. We hypothesized that intervention group participants would report better QoL, more physical activity, and improved dietary habits after 3 months.ResultsIntention-to-treat (ITT) analyses revealed significant effects on QoL (d = 0.27, 95% CI: 0.07–0.48) and dietary habits (d = 0.36, 95% CI: 0.15–0.56), but the effect on physical exercise was not significant (d = 0.30; 95% CI: 0.10–0.51).DiscussionThese findings suggest the effectiveness of Optimune, a new CBT-based Internet intervention for breast cancer survivors, in facilitating improvements in quality of life and dietary habits. Efforts to disseminate this intervention more broadly may be warranted.Trial registrationClinicalTrials.gov, NCT03643640. Registered August 23rd 2018, https://clinicaltrials.gov/ct2/show/NCT03643640.

Behavioral Therapy Teams for Obsessive-Compulsive Disorder: Lessons Learned From a Pilot Randomized Trial in a Community Mental Health Center

Community mental health centers (CMHCs) provide the majority of mental health services for low-income individuals in the United States. Exposure and response prevention (ERP), the psychotherapy of choice for obsessive-compulsive disorder (OCD), is rarely delivered in CMHCs. This study aimed to establish the acceptability and feasibility of testing a behavioral therapy team (BTT) intervention to deliver ERP in CMHCs. BTT consisted of individual information-gathering sessions followed by 12 weeks of group ERP and concurrent home-based coaching sessions. The sample consisted of 47 low-income individuals with OCD who were randomized to receive BTT or treatment as usual (TAU). Symptom severity and quality-of-life measures were assessed at pretreatment, posttreatment, and 3- and 6-month posttreatment. Feasibility of training CMHC staff was partially successful. CMHC therapists successfully completed rigorous training and delivered ERP with high fidelity. However, training paraprofessionals as ERP coaches was more challenging. ERP was feasible and acceptable to patients. BTT participants were more likely than TAU participants to attend their first therapy session and attended significantly more treatment sessions. A large between-group effect size was observed for reduction in OCD symptoms at posttreatment but differences were not maintained across 3- and 6-month follow-ups. For BTT participants, within-group effect sizes reflecting change from baseline to posttreatment were large. For TAU participants, depression scores did not change during the active treatment phase but gradually improved during follow-up. Results support feasibility and acceptability of ERP for this patient population. Findings also underscore the importance of implementation frameworks to help understand factors that impact training professionals.

Health-Related Quality of Life in Patients with Breast Cancer in Latin America and the Caribbean: A Systematic Review and Meta-Analysis.

Background and ObjectivesBreast cancer (BC) is the most common cancer in women. It imposes a huge disease burden and a significant impact on health‐related quality of life (HRQoL). Our study focused on HRQoL of patients with BC in Latin America and the Caribbean (LAC). We conducted a systematic review to identify relevant articles published between 2008 and August 2018. We conducted several meta‐analyses and subgroup analyses by country, disease stage, and instrument used (Prospective Register Of Systematic Reviews registration number: CRD42018106835).ResultsFrom 2,265 initial references, we finally included 75 articles (8,806 participants) that assessed HRQoL. The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 and B23 modules (34 studies; 8 countries; 4,866 participants) were the most used instruments, followed by the Short Form 36‐item, the abbreviated version of the World Health Organization Quality of Life instrument, and the Functional Assessment of Cancer Therapy – Breast instrument. Only four studies reported specific HRQoL data of patients with metastatic disease. Half the studies were rated as having moderate quality (38/75), and 38% (29/75) as high quality. We identified substantial heterogeneity. As expected, the meta‐analyses revealed that patients with metastatic disease reported lower HRQoL values and high symptom burden compared with patients at earlier stages. Similar results can be observed when we compared patients with early breast cancer in active treatment phases versus those in follow‐up.ConclusionThis study provides a synthesis of breast cancer HRQoL reported in LAC and exposes existing evidence gaps. Patients with BC in active treatment or with metastatic disease had worse HRQoL compared with survivors during the follow‐up period.Implications for PracticeThis systematic review provides an exhaustive synthesis of breast cancer health‐related quality of life in women in the Latin American and Caribbean region. Patients with breast cancer in active treatment or with metastatic disease had worse health‐related quality of life compared with survivors during the different follow‐up periods. This study also shows important evidence and methods gaps that can help inform future research.

Do Social Cognition Deficits Recover with Abstinence in Alcohol-Dependent Patients?

BackgroundDespite growing evidence of the presence and clinical relevance of deficits in social cognition in individuals with alcohol use disorder (AUD), less is known about the potential of “natural” recovery with abstinence in this neurocognitive domain. This study investigated the abstinence‐based recovery of neurocognitive social abilities in alcohol‐dependent patients (ADP) using a prospective longitudinal design with follow‐up assessment under controlled conditions of abstinence during alcohol dependence inpatient treatment.MethodsSeventy‐seven participants (42 ADP and 35 healthy controls [HC]) performed social cognition testing, including facial emotion recognition, perspective taking, and affective responsiveness twice (baseline/T1 and follow‐up/T2) during comparable follow‐up periods. Assessment of social cognition in abstinent ADP was conducted at the beginning (T1; within the first 2 weeks) and at the end (T2; within the last 2 weeks) of long‐term (2 months) abstinence‐oriented alcohol dependence inpatient treatment. Only patients abstinent for >14 days (last heavy drinking day >21 days) at baseline (T1) and who remained abstinent at follow‐up (T2) were included.ResultsADP, who on average were nearly 2 months abstinent at T1, showed poorer social cognition in all 3 areas (emotion recognition, perspective taking, and affective responsiveness) than HC. There was no difference between groups on the change in performance over time, and group differences (ADP vs. HC) remained significant at T2, indicating persistent social cognition deficits in ADP following controlled abstinence during inpatient treatment.ConclusionsOur findings indicate no natural recovery of social cognition impairments in ADP during an intermediate to long‐term period of abstinence (2+ months), the usual active treatment phase. Research aimed at developing interventions that focus on the improvement of social cognition deficits (e.g., social cognition training) and determining whether they benefit short‐ and long‐term clinical outcomes in AUD seems warranted.

Care partner-assisted intervention to improve oral health for older adults with cognitive impairment: A feasibility study.

Older adults with cognitive impairment often experience poor oral health outcomes due to inadequate oral hygiene practices. This pilot study aimed to evaluate the feasibility of a care partner-assisted intervention to improve the oral hygiene of community-dwelling older adults with cognitive impairment. The 6-month intervention included 25 older adults with mild dementia or mild cognitive impairment, who were randomly assigned to Treatment Group 1 or Treatment Group 2. Treatment Group 1 (n=7) received an educational booklet. Treatment Group 2 (n=18) received a booklet, a tailored care plan for the participants with cognitive impairment and the care partner received four coaching sessions to learn to facilitate good oral hygiene. Both groups received electric toothbrushes. The study consisted of a 3-month active intervention and 3-month maintenance phase. The outcomes of gingival index, plaque index and overall oral health status based on the Oral Health Assessment Tool were measured at baseline, 3months (end of active intervention) and 6months of the study. This study had very low dropout rate. Participants' oral hygiene improved in this study. In comparison to Treatment Group 1, participants in Treatment Group 2 had a greater reduction in plaque level and gingival inflammation, and greater improvement in overall oral health status. This study demonstrates the feasibility of this intervention designed to improve the oral health of persons with cognitive impairment and it lays the foundation for using this protocol in a future large randomised clinical trial.

Cancer survivors' experiences of an exercise program during treatment and while employed: A qualitative pilot study.

This study examined breast cancer survivors' (BCS) views on the role of exercise therapy while they were working in employment during cancer treatment. Research was undertaken with five participants who undertook an exercise programme as adjuvant care during treatment for breast cancer. Four female and one male client, the only clients who met the criteria for study in the clinic, were interviewed twice each during a two-month period. Participants wrote diaries to supplement the interview data and provide prompts for the second interview. An interpretive paradigm was used to identify themes for analysis. A multiple coding approach was used to interpret the data. The study was conducted at a small breast cancer recovery clinic, situated at a university in the South Island of New Zealand. Participants reported that exercise was essential to their ability to work through the active treatment phase and provided positive effects on social, mental and emotional well-being. Exercise therapy is an important element of enabling to work during treatment, for physical, mental and social well-being. SO WHAT?: Future research is required on support for employers to enable exercise therapy for employees; the needs of self-employed patients; tailoring exercise therapy for patients for whom social support is not a primary motivation; and the place of a clinic as a 'middle-ground' between social and emotional support and an exercise clinic.

Veterans’ Treatment Engagement and Dropout from Couple and Family Therapy in a Veterans Affairs Health Care System

The present study utilizes data from a Couple and Family Therapy Program in the Veterans Affairs Health Care System (VAHCS) seeks to understand veterans’ and their family members’ treatment engagement and dropout from initial referral for therapy to the active phase of treatment. Veterans (N = 177) referred to couple or family therapy were included in the study, and data about session attendance was collected through chart reviews. About 60% of couples and families dropped out at some point between referral to entering the active phase of treatment. Results showed that the majority of dropout occurred between the phone screen and the first session, with significant attrition also occurring between the first session and the assessment phase of treatment. In examining individual, relational, and logistical factors, a chronic pain diagnosis and serving during the Post-9/11 era were related to completion of various phases of therapy. Findings have implications for enhancing efforts to engage and retain veterans and their family members in treatment. Specific strategies for clinicians are discussed, with a focus on the shift to telehealth in the VAHCS and other health care settings in response to the COVID-19 pandemic.

Design considerations for a remote randomized multi-site clinical trial evaluating an e-health self-management program for chronic pain patients receiving opioid therapy

Based on the adverse consequences and inadequate evidence of effectiveness for long-term opioid therapy (LOT), the CDC developed recommendations to decrease the use of LOT and morphine equivalent dose (MED) for patients receiving LOT. However, the majority of these patients report that opioid medication is significantly beneficial for pain management and are hesitant to reduce/decrease its use. Compounding the problem is poor access to non-pharmacologic therapies for many patients due to insurance reimbursement structures and limited pain-service availability. EMPOWER is an intent-to-treat, two-arm, open-label, randomized controlled trial evaluating a web-based self-management chronic pain program (E-Health) that has been found to reduce self-reported MED, while also decreasing pain, in two randomized controlled trials. Approximately 400 chronic pain patients receiving LOT at a daily average prescribed MED ≥ 20 mg at one of two U.S. healthcare systems, located in North Carolina and Ohio, will be randomized in a 1:1 ratio to treatment as usual (TAU) or TAU plus E-Health (E-Health+). TAU consists of LOT from a prescribing clinician. E-Health+ participants are provided with a 4-month E-Health subscription (active treatment phase). All participants will complete web-based self-report measures at baseline, the end of the active treatment phase, and 6-months post-active treatment. Opioid prescription information will be collected from the participants' electronic health record (EHR) from baseline through 6 months post-active treatment. This paper describes design considerations for this unique trial which is conducted completely remotely, with no in-person visits, and utilizes the EHR for participant identification and primary outcome collection.

The Comparative Efficacy of Conventional Short-Stretch Multilayer Bandages and Velcro Adjustable Compression Wraps in Active Treatment Phase of Patients with Lower Limb Lymphedema.

Background: Compression is the most important component of complete decongestive therapy (CDT), but there is no standard best method for applying compression. The aim of this study was to evaluate the comparative efficacy of conventional multilayer short-stretch bandaging, and a velcro adjustable compression wrap with regard to volume reduction, ultrasonographic measurements, functional-status, and quality of life (QoL) in the active CDT period of patients with lower limb lymphedema. Methods and Results: The demographic and clinical variables of lower limb lymphedema patients were recorded. All patients received skin care education, manual lymphatic drainage, and supervised lyphedema exercises, and were randomly allocated to Group1 (multilayer short-stretch bandaging-Rosidal-K®) or to Group 2 (adjustable-compression-velcro-wrap-Circaid Reduction-kit®) for a duration of 3 weeks with 15 sessions. Limb volumes were assessed by perometer. Ultrasonographic measurements included subcutaneous soft tissue thickness. The functional disability and QoL were evaluated by the Lower Extremity Functional Scale and LYMQOL-Leg (Lymphedema Quality of Life Questionnaire-Leg), respectively, at baseline, after CDT, and at first-month follow-up. Thirty-six patients (10 male and 26 female) with mean age of 51.6 ± 11.7 years were included. Fourteen patients had primary and 22 patients had secondary lymphedema. The median duration of lymphedema was 68 months. Significant improvements in volumes and ultrasonographic measurments were observed in both groups at the end of therapies, and improvements sustained up to a month. Appearance, symptoms, and overall QoL-subscores were improved only in Group 2. Conclusion: In conclusion, adjustable compression velcro-wrap performed as a part of CDT can greatly reduce the volume similiar to conventional multilayer bandages, as well as improve the QoL. It can be a comfortable alternative to the conventional multilayer bandages in the active treatment phase of the CDT.

Perception of disease, dyadic coping and the quality of life of oncology patients in the active treatment phase and their life partners: Study protocol of an approach based on the actor-partner interdependence model.

Coping with cancer is a challenge for both patients and their life partners. Although there is evidence in the literature that supports the patient/partner mutual influence at the level of various psychological variables, it is still limited. This study, based on the Systemic Transactional Model, aims to investigate: 1) how the perception of disease of patients and their life partners influences their own dyadic coping and that of the other member of the couple; 2) the influence of the dyadic coping of patients and their partners on the quality of their own life and that of the other member of the couple. This cross-sectional study aims to recruit 131 dyads consisting of oncology patients in the active treatment phase and their life partners. Perception of disease, dyadic coping and quality of life will be evaluated for each participant. The collected data will be analysed by applying the actor-partner interdependence model (APIM). The results highlighted in this study have the potential to help define future couple interventions that aim to improve quality of life of those facing cancer.

Neurobiological predictors for clinical trajectories in fully remitted depressed patients.

BackgroundSerious long term health and economic detriment accompany residual depressive symptoms even in fully remitted depressed patients (rMDD). Neurobiological predictors for rMDD patients’ illness trajectory are absent.MethodsrMDD patients (n = 39, female = 26) underwent magnetic resonance imaging. Baseline analyses of brain structure via voxel‐based morphometry and brain function via functional connectivity (FC) at rest were correlated with changes in the Hamilton Depression Rating Scale between baseline and follow‐up, and incidence of a recurrent major depressive episode (MDE) within a 2‐year period.ResultsGray matter increases in default mode (DN) regions in the posterior cingulate cortex (PCC) and increased resting‐state FC within the DN both predicted change of depressive symptoms. Patients with recurrent MDE had larger bilateral nucleus accumbens and left insula volumes. Post hoc exploratory analysis of nucleus accumbens and insula conceptualized as part of the brain's reward circuit demonstrated reduced connectivity in patients with recurrent MDE.ConclusionsHigher DN connectivity and PCC volume coinciding with a more favorable course of symptoms suggest neural mechanisms of self‐recovery beyond the phase of active medical treatment. Alterations in the brain's reward circuit might be a starting point for designing maintenance treatments that prevent recurrent MDEs in rMDD patients.

Inventory of tools for care coordination between general practice and hospital system for patients suffering from cancer in active phase of treatment: A scoping review.

During the active phase of treatment, major difficulties appear in the transmission and quality of the information communicated to the General Practitioner (GP). Our objective was to carry out an inventory of the coordination tools used to improve exchanges between the hospital and the GP in the management of the patient suffering from cancer during this phase. A scoping review was conducted using MEDLINE databases via PubMed, The Cochrane Library, Web of Science. Articles published between 1998 and 2018, in English and French, were analysed. Over 4,863 articles were extracted, and 11 studies were included. They highlight an increase in the quality of patient care after the introduction of information sheets or training by video vignettes with GPs. They demonstrate the importance of using standardised letters between health professionals. The role of a "leader physician" is discussed, and its first evaluations are positive. An increase in information transmitted to GPs leads to a better satisfaction of patients and GPs. Communication tools are essential for the transmission of information, but direct and oral communication between all health professionals seems to be a point to be further developed.

Evaluation of photobiomodulation therapy to accelerate bone formation in the mid palatal suture after rapid palatal expansion: a randomized clinical trial.

To evaluate the efficiency of photobiomodulation therapy (PBMT) in the midpalatal suture (MPS) and pain sensation in patients undergoing rapid palatal expansion (RPE). Thirty-four individuals with the diagnosis of skeletal maxillary hypoplasia were divided in two groups: laser (n = 18) and control (n = 16). Treatment plan consisted of the use of the Hyrax expander in all patients. Subjects in the laser group were irradiated with diode laser (980nm, 0.3W) in six spots bilaterally distributed along the MPS for 10s during the active phase of treatment and after overcorrection (passive phase of RPE). Control group received sham irradiations with the laser in standby mode to characterize the placebo effect. Digital occlusal radiographs were performed at different time-points for bone formation evaluation in both groups. The effects of laser irradiation on pain were assessed by the visual analog scale (Wong-Baker Faces Pain Scale). Bone formation between groups was not significantly different (p = 0.2273). At 3months, bone formation was not yet complete in both groups. Pain sensation was similar between groups (p = 0.3940). However, pain was significantly higher for the first 7days of treatment compared with the 14th day. PBMT did not accelerate bone regeneration in the MPS and pain sensation was similar.

Society of Behavioral Medicine (SBM) position statement: support increased knowledge and efforts to address the financial burden associated with cancer treatment.

Millions of individuals and their families struggle with both treatment-related and out-of-pocket (OOP) economic repercussions of a cancer diagnosis, an effect increasingly referred to as "financial toxicity." In 2014, the Agency for Healthcare Research and Quality (AHRQ) estimated the total U.S. expenditures for cancer at $87.8 billion dollars with patient OOP costs accounting for $3.9 billion dollars (2014). These figures do not take into account indirect costs, such as those from lost earnings. As a result, financial toxicity can extend well beyond the active treatment phase and have a substantial impact on a household's economic reserve and financial resilience well into the future. Of the 9.5 million U.S. adults aged 50 years and older diagnosed with cancer (2000-2012), 42.2% have depleted their assets at 2 years and 38.2% were financially insolvent in 4 years. Bankruptcy rates are 2.65 times higher among cancer survivors than matched controls. A full 70% of Americans want to have conversations about the costs of care with their health care providers, but only 28% report doing so. Delaying or deferring these conversations can have major financial consequences for patients. According to a polling conducted for the Robert Wood Johnson Foundation (RWJF) by Avalere Health, almost 20% of patients report forgoing care when they have questions about costs. A critical element to achieve this is to have accurate cost information, including health care insurance coverage policies. Specifically, while patients and their families look to their health care providers to help them better navigate the cost implication of their treatment choices, most who are willing to undertake this challenging task need to have accessible and comprehensive (including direct and indirect) cost information to facilitate the discussion.

Assessment of contributing factors for discontinuation of orthodontic treatment

Objectives: The aims of this study were to assess the prevalence and associated contributory factors for discontinuation of orthodontic treatment. Materials and Methods: A hospital-based retrospective study was conducted with the treatment records, whose orthodontic treatment was commenced in the year 2015 at the Division of Orthodontics, University Dental Hospital, Peradeniya. Information regarding age, gender, type of malocclusion, Index of Orthodontic Treatment Need, appliance type, duration of treatment, extraction versus non-extraction, stage of treatment, and the cost of treatment was obtained from the patient’s records. Statistical analysis was performed using the statistical software R 3.5.0. Results: The sample consisted of 310 treatment cases, of which 40 (12.9%) patients were discontinued. Among the discontinued patients, 50.6% were male and 49.3% were female. The discontinuation rate in the group of 12–17 years was higher than the other age groups, which was statistically significant (P = 0.005). Among the group of discontinued treatment, 49.3% were of Class II division 1 malocclusion and 37.1% and 37.4% of patients were in Grade 3 and 4 of IOTN, respectively. About 37% of patients have been discontinued before completion of 1 year which was statistically significant (P = 0.0005). About 59.5% of non-extraction patients were in the treatment discontinuation group which was also statistically significant (P = 0.023). About 32.5% of the patients who discontinued have obtained the treatment with the lowest cost with statistical significance (P = 0.026). Conclusion: Children with borderline and moderate occlusal irregularities treated with simple removable appliances which are affordable with low cost were more prone to discontinue in the early phase of active treatment.

Contraceptive vaginal ring reduces lamotrigine levels

ObjectiveThe objective of the study was to describe the effect of the vaginal ring and transdermal patch on lamotrigine serum levels in women with epilepsy. BackgroundPrevious studies demonstrate that oral hormonal contraceptives containing synthetic estrogen increase lamotrigine clearance through induction of glucuronidation. This leads to variable lamotrigine serum concentrations throughout monthly cycles in women who are on combined oral contraceptives (COCs). The effects of estrogen-containing nonoral hormonal contraceptive methods, including the vaginal ring and transdermal patch, on lamotrigine pharmacokinetics are not well described. MethodsRetrospective chart review was performed to identify serum lamotrigine levels drawn from women with epilepsy while on the active phase of vaginal ring or transdermal patch and while off contraception. Wilcoxon signed-rank tests for paired data were used to compare the difference in dose-corrected lamotrigine concentration in plasma between values while on hormonal contraception to those while off contraception in patients using a vaginal ring. ResultsSix patients were using the vaginal ring, and one patient was using the transdermal patch. Lamotrigine dose-corrected concentrations were decreased during the active phase of the vaginal ring compared with concentrations during the period off contraception (p = .04). There was one patient without a decrease in concentration, but the other five patients on the vaginal ring had a decrease in dose-corrected lamotrigine concentration ranging from 36 to 70% while on the vaginal ring. Similarly, one patient using the transdermal patch had a decrease of 37% in dose-corrected lamotrigine concentration while on the patch. ConclusionsThe findings support that the vaginal ring contraceptive method decreases lamotrigine concentrations during the active phase of treatment. This has important implications for contraceptive counseling and maintaining therapeutic levels in women of childbearing age with epilepsy.

Abstract A073: A qualitative exploration of social support needs of diverse patients with breast cancer in the adjuvant phase of treatment

Abstract Background: Women diagnosed with breast cancer transitioning from the active phase of treatment to the adjuvant phase of treatment experience fewer opportunities to receive support from their oncology team. During this period of time, the frequently unfulfilled social support needs reported by many oncology patients may be exacerbated for these women. Having social support is a critical component of cancer care and is associated with positive patient outcomes, including medication adherence and survival. Our study uses qualitative methods to evaluate the social support needs of a diverse group of women in the adjuvant phase of treatment and investigate any potential impact on cancer disparities. Method: Four 90-minute focus groups (N= 28) were conducted among women with breast cancer treatment who were prescribed tamoxifen or aromatase inhibitors, and then stratified by race (Black and White) and length of adjuvant treatment (i.e., < 6 month or > 6 month). These focus groups were held at a regional cancer center in the Mid-Southern US, a region with high Black-White breast cancer outcome disparities. The data were examined in accordance with conventions of thematic analysis to assess many topics related to the breast cancer experience including social support needs. Results: Both Black and White participants expressed a preference for having frequent and consistent access to providers to minimize feelings of isolation and meet new and persisting emotional and informational social support needs. Specifically, a participant highlighted how critical it was that she was “able to call my primary care provider” and spend “quite some time” so that she could get questions answered and ease her fears. The support from friends and family was also highlighted by the women. In addition, several women from each focus group expressed the importance of having loved ones present during important medical visits. For example, some participants mentioned patients needing “family or anybody around to discuss the findings” or having “someone to hug.” Most notably, participants sought and provided social support to each other in the focus group itself, exhibiting a phenomenon referred to as “experiential social support.” This was best exemplified by several recommendations in each focus group to “form support groups” and “meet once a month” as an outlet to discuss experiences and reciprocally provide support. Conclusions: Irrespective of race, women in the adjuvant phase of treatment reported needing more resources to meet their social support needs during this period of increased stress and less provider contact. The women found experiential support to be a vital component in meeting social support needs. Providers should consider implementing standardized methods to address the unmet social support needs of patients. For example, providers could assess for deficits in social support on a continuous basis (e.g., screening questions) and offer resources such as support groups and assigned patient advocates to fill gaps. Citation Format: Andrew J. Paladino, Janeane Anderson, Rebecca Krukowski, Lee Schwartzberg, J. Carolyn Graff, Tameka N. Jones, Gregory A. Vidal, Mehmet Kocack, Ilana Graetz. A qualitative exploration of social support needs of diverse patients with breast cancer in the adjuvant phase of treatment [abstract]. In: Proceedings of the Eleventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2018 Nov 2-5; New Orleans, LA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl):Abstract nr A073.

Protocol for a systematic review of self-management interventions for older adults living with cancer

BackgroundCancer predominates in adults over age 65. Cancer treatments are known to create physical and psychosocial challenges, which may be amplified for older adults with cancer.Learning and applying self-management behaviours and skills during treatment with cancer can help to manage/recover health and improve quality of life. In many other chronic illnesses, self-management interventions are known to improve health outcomes and lower healthcare costs. The purpose of this systematic review is to determine the effectiveness of self-management interventions for older adults with cancer on physical, psychosocial, and health system-related outcomes.MethodsWe are conducting a systematic review of self-management interventions for older adults (65+) diagnosed with cancer (solid tumour or haematological) in the active treatment phase of cancer. This systematic review is guided by the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) statement. Studies are limited to experimental or quasi-experimental methods published in English, French, German, or Dutch. A search strategy was designed with a Health Sciences librarian and performed using the following electronic databases: Ageline, AMED, ASSIA, Cinahl, Cochrane, Embase, Medline, PsychINFO, and Sociological s. Approximately 14,000 titles and abstracts are being electronically screened by a minimum of 2 reviewers, with relevant studies to be screened for full text. The final sample of included studies will be assessed for quality using the Cochrane Risk of Bias tool and Down and Black for quasi-experimental studies, with data synthesized in a narrative and tabular format.DiscussionThis systematic review will expand the knowledge base of interventions supporting self-management for older adults with cancer. This study will inform future intervention development by identifying gaps and strengths in effective self-management interventions targeting the needs of older adults receiving active treatment for cancer.Systematic review registrationPROPERO registry ID# CRD42019134113

Evaluation of Human Papillomavirus Vaccination After Pharmacist-Led Intervention: A Pilot Project in an Ambulatory Clinic at a Large Academic Urban Medical Center

ObjectivesDespite the safety and efficacy of the human papillomavirus (HPV) vaccine, many persons are still not receiving it. The purpose of this pilot project was to evaluate the number of first doses of the 9-valent HPV (9vHPV) vaccination administered after a pharmacist-led intervention in the Adult Family Planning Clinic at Grady Health System (GHS), a large academic urban medical center in Atlanta, Georgia.MethodsThe pilot project had 3 phases: pre-intervention (November 15, 2016, through March 31, 2017), active intervention (November 15, 2017, through December 29, 2017), and post-intervention (December 30, 2017, through March 31, 2018). The pre-intervention phase was used as a historical control. The active intervention phase consisted of pharmacist interventions in the clinic and patient and health care provider education. The post-intervention phase evaluated the durability of pharmacist-led interventions performed and education provided during the active phase.ResultsEighty-nine first-dose 9vHPV vaccines (of the 3-dose series) were administered to young adults aged 18-26 during the project period (November 15, 2017, through March 31, 2018); none were administered during the pre-intervention phase. Of 89 patients who received a first 9vHPV vaccine dose, 20 patients also received a second 9vHPV vaccine dose. During the project period, 166 doses of 9vHPV vaccine (first, second, or third doses) were administered.ConclusionThis pharmacist-led intervention led to an increase in the number of young adult patients receiving their first dose of the 9vHPV vaccination series. With the support of other health care providers, pharmacist-led initiatives can expand vaccine-related health literacy and facilitate access to immunization services.