A Mixed-apprOach program To help women wIth breast cancer stay actiVE (MOTIVE program): A pilot-controlled study
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ABSTRACT:
SUBMITTER: Natalucci V
PROVIDER: S-EPMC8572138 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundDespite the continued progress of medicine, dealing with breast cancer is becoming a major socioeconomic challenge, particularly due to its increasing incidence. The ability to better manage and adapt to the entire care process depends not only on the type of cancer but also on the patient's sociodemographic and psychological characteristics as well as on the social environment in which a person lives and interacts. Therefore, it is important to understand which factors may contribute to successful adaptation to breast cancer. To our knowledge, no studies have been performed on the combination effect of multiple psychological, biological, and functional variables in predicting the patient's ability to bounce back from a stressful life event, such as a breast cancer diagnosis. Here we describe the study protocol of a multicenter clinical study entitled "Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE Back" or, in short, BOUNCE.ObjectiveThe aim of the study is to build a quantitative mathematical model of factors associated with the capacity for optimal adjustment to cancer and to study resilience through the cancer continuum in a population of patients with breast cancer.MethodsA total of 660 women with breast cancer will be recruited from five European cancer centers in Italy, Finland, Israel, and Portugal. Biomedical and psychosocial variables will be collected using the Noona Healthcare platform. Psychosocial, sociodemographic, lifestyle, and clinical variables will be measured every 3 months, starting from presurgery assessment (ie, baseline) to 18 months after surgery. Temporal data mining, time-series prediction, sequence classification methods, clustering time-series data, and temporal association rules will be used to develop the predictive model.ResultsThe recruitment process stared in January 2019 and ended in November 2021. Preliminary results have been published in a scientific journal and are available for consultation on the BOUNCE project website. Data analysis and dissemination of the study results will be performed in 2022.ConclusionsThis study will develop a predictive model that is able to describe individual resilience and identify different resilience trajectories along the care process. The results will allow the implementation of tailored interventions according to patients' needs, supported by eHealth technologies.Trial registrationClinicalTrials.gov NCT05095675; https://clinicaltrials.gov/ct2/show/NCT05095675.International registered report identifier (irrid)DERR1-10.2196/34564.
| S-EPMC9607923 | biostudies-literature
Project description:Background:Internet-based cognitive behavioral therapy (ICBT) has proven to be an effective treatment in improving patients' ability to cope with tinnitus. However, some patients prefer face-to-face therapy to ICBT, and a few studies have shown considerable dropout rates if the treatment is not guided. This renders it important to identify factors that contribute to the commencement and continuation of ICBT programs. Aims:Because treatment motivation and expectations are important factors in psychological treatment, the aim of our study was to investigate what leads tinnitus patients to seek out ICBT, what helps them to keep up with the treatment, and what (if any) impact these factors have on dropout rates and treatment outcomes. Method:112 tinnitus patients taking part in ICBT for tinnitus responded to symptom-related questionnaires at three points in time (pre-treatment, post-treatment, and one-year-follow-up) and to a questionnaire consisting of open-ended questions about their treatment motivation and expectations before beginning treatment. Data were analyzed using qualitative content analysis, and the results were used to divide the participants into groups. The treatment outcomes of these groups were compared using t-tests, ?2-tests, and both one-factorial and mixed ANOVAs. Results:Four main categories emerged as factors conducive to starting treatment: 1) Targets participants wanted to address, 2) circumstances that led to participation, 3) attitudes towards the treatment, and 4) training features. Participants identified six facilitators for continuing the treatment: success, training, individual attitude, hope, evidence, and support. Naming specific tinnitus-associated problems as targets was associated with greater improvement from pre-treatment to 1-year-follow-up. Describing an active involvement in the treatment was related to increased improvement from post-treatment to follow-up. Conclusion:There are several motivational factors that tinnitus patients consider relevant for beginning and continuing ICBT. Particularly, focusing on specific targets that do not involve the tinnitus itself, and encouraging participants to take an active role in treatment may increase treatment effectiveness. However, further hypothesis-guided research is necessary to confirm our explorative results.
| S-EPMC6096122 | biostudies-literature
Project description:BackgroundImproving help-seeking behaviour is a key component of down-staging breast cancer and improving survival, but the specific challenges faced by low-income women in an Asian setting remain poorly characterized. Here, we determined the extent of help-seeking delay among Malaysian breast cancer patients who presented at late stages and explored sub-groups of women who may face specific barriers.MethodsTime to help-seeking was assessed in 303 women diagnosed with advanced breast cancer between January 2015 and March 2020 at a suburban tertiary hospital in Malaysia. Two-step cluster analysis was conducted to identify subgroups of women who share similar characteristics and barriers. Barriers to help-seeking were identified from nurse interviews and were analyzed using behavioural frameworks.ResultsThe average time to help-seeking was 65 days (IQR = 250 days), and up to 44.5% of women delayed by at least 3 months. Three equal-sized clusters emerged with good separation by time to help-seeking (p < 0.001). The most reported barrier across clusters was poor knowledge about breast health or breast cancer symptoms (36.3%), regardless of help-seeking behaviour (p = 0.931). Unexpectedly, women with no delay (9 days average) and great delay (259 days average) were more similar to each other than to women with mild delays (58 days average), but, women who experienced great delay reported poor motivation due to fear and embarrassment (p = 0.066) and a lack of social support (p = 0.374) to seek help.ConclusionsDown-staging of breast cancer in Malaysia will require a multi-pronged approach aimed at modifying culturally specific social and emotional barriers, eliminating misinformation, and instilling motivation to seek help for breast health for the women most vulnerable to help-seeking delays.
| S-EPMC9976530 | biostudies-literature
Project description:BackgroundTobacco smoke exposure (TSE) and inappropriate sleep position/environments contribute to preventable infant deaths. The objective of our quality improvement (QI) program was to increase primary care provider (PCP) screening and counseling for TSE and safe sleep risks at well-child visits (WCVs) and to assess caregiver behavior changes at subsequent visits.MethodsPediatric practices, recruited from the Ohio Chapter, American Academy of Pediatrics' database, self-selected to participate in this TSE and safe sleep PCP QI program. At every WCV over a 10-month period, caregivers with children < 1 year old were to be screened and counseled by providers. Caregiver demographics, TSE, and safe sleep practices were assessed. Individual PCP results were paired with subsequent family screening tools at follow up visits to determine changes in TSE and safe sleep practices. Differences in frequencies were determined and paired t-tests were used to compare means.ResultsFourteen practices (60 providers) participated; 7289 screens were completed: 3972 (54.5%) initial screens and 1769 (24.3%) subsequent WCV screens. Caregivers on the initial screen were primarily white (61.7%), mothers (86.0%) with public insurance (41.7%). Within the first month after QI program initiation, PCPs TSE screening was during 80% of WCVs, which increased to > 90% by end of the QI program. A total of 637 /3953 (16.1%) screened positive for home TSE on the initial visit: 320/3953 (8.1%) exposed by at least the primary caregivers, and 317/3953 (8.0%) exposed by a home adult smoker (not the identified caregiver). Of caregivers receiving smoking counseling with subsequent follow-up WCV (n = 100), the mean number of cigarettes smoked daily decreased significantly from 10.6 to 4.6 (p = 0.03). Thirty-four percent of caregivers (34/100) reported they quit smoking at their second visit. A total of 1072 (27%) infants screened at risk for inappropriate sleep position or environment at their initial visit. Of these at-risk infants whose caregivers received safe sleep counseling, 49.1% practiced safer sleep behaviors at follow-up.ConclusionsPCPs participating in a QI program increased screening at WCVs for infant mortality risks. After counseling and providing resources about TSE and safe sleep, many caregivers reported practicing safer behaviors at their next WCV.
| S-EPMC7291417 | biostudies-literature
Project description:BackgroundSexual problems are extremely common for women after breast cancer (BC).AimTo determine, in a sample of BC outpatients, how commonly women sought help for sexual concerns, from a health care provider (HCP), from other individuals, or from alternate sources; and to examine whether help-seeking was associated with women's sexual function/activity, self-efficacy for clinical communication about sexual health, or sociodemographic/medical characteristics.MethodsBC patients participating in a sexual/menopausal health communication intervention trial completed web-based baseline self-report surveys. One-way analysis of variances compared effects of the level of sexual help-seeking (none; 1 outlet; 2-3 outlets) on sexual function domains. Chi-square or t-tests compared women seeking help with those not seeking help on other study variables.Main outcome measuresPatient-reported outcome instruments assessed sexual help-seeking (past month), sexual function and activity (PROMIS Sexual Function and Satisfaction Brief Profile Version 2.0), and self-efficacy (confidence) for communicating with their BC clinician about sexual health.Results144 women (mean age = 56.0 years; 62% partnered; 67% white; 27% black/African American; 4% Hispanic/Latina; 15% stage IV) participated in this study. 49% of women sought help for sexual concerns, most often from intimate partners, family and/or friends (42%), followed by HCPs (24%), or online/print materials (19%); very few women (n = 4; 3%) sought help only from a HCP. Women seeking help were younger and more likely to be partnered and sexually active than those not seeking help. Sexual function was impaired for all domains but was most impaired for sexual interest. Among sexually active women, those seeking help from 2 to 3 sources reported worse sexual function in certain domains (sexual interest, lubrication, vaginal discomfort, vulvar discomfort-labial, satisfaction). Women seeking help from outlets other than HCPs had significantly lower self-efficacy than those who did not.Clinical implicationsBC patients with access to a partner and who are sexually active but find sex unsatisfying, uncomfortable, or lack interest may be in particular need of sexual help. Further, women may turn to outlets other than HCPs for sexual help partly because they lack the confidence to do so with a HCP. Sexual health information should be made available to women's partners, family, and friends, so they may effectively discuss such issues if needed.Strengths & limitationsStrengths of the study included examination of a range of sexual function domains and a theoretical construct in relation to BC patients' sexual help-seeking and a medically diverse sample. Limitations include a cross-sectional design.ConclusionWomen treated for BC should receive accurate and timely sexual health information. Reese JB, Sorice KA, Pollard W, et al. Understanding Sexual Help-Seeking for Women With Breast Cancer: What Distinguishes Women Who Seek Help From Those Who Do Not? J Sex Med 2020;17:1729-1739.
| S-EPMC7756247 | biostudies-literature
Project description:Importance:Enhanced recovery protocols (ERPs) are standardized care plans of best practices that can decrease morbidity and length of stay (LOS). However, many hospitals need help with implementation. The Enhanced Recovery in National Surgical Quality Improvement Program (ERIN) pilot was designed to support ERP implementation. Objective:To evaluate the association of the ERIN pilot with LOS after colectomy. Design, Setting, and Participants:Using a difference-in-differences design, pilot LOS before and after ERP implementation was compared with matched controls in a hierarchical model, adjusting for case mix and random effects of hospitals and matched pairs. The setting was 15 hospitals of varied size and academic status from the National Surgical Quality Improvement Program. Preimplementation and postimplementation colectomy cases (July 1, 2013, to December 31, 2015) were collected using novel ERIN variables. Emergency and septic cases were excluded. A propensity score match identified a 2:1 control cohort of patients undergoing colectomy at non-ERIN hospitals. Interventions:Pilot hospitals developed and implemented ERPs that included expert guidance, multidisciplinary teams, data audits, and opportunities for collaboration. Main Outcomes and Measures:The primary outcome was LOS, and the secondary outcome was serious morbidity or mortality composite. Results:There were 4975 colectomies performed by 15 ERIN pilot hospitals (3437 before implementation and 1538 after implementation) compared with a control cohort of 9950 colectomies (4726 before implementation and 5224 after implementation). The mean LOS decreased by 1.7 days in the pilot (6.9 [interquartile range (IQR), 4-8] days before implementation vs 5.2 [IQR, 3-6] days after implementation, P < .001) compared with 0.4 day in controls (6.4 [IQR, 4-7] days before implementation vs 6.0 [IQR, 3-7] days after implementation, P < .001). Readmission did not differ pre-post for the pilot or controls. Serious morbidity or mortality decreased for pilot participants (485 [14.1%] before implementation vs 162 [10.5%] after implementation, P < .001), with no difference in controls, and remained significant after risk adjustment (adjusted odds ratio, 0.76; 95% CI, 0.60-0.96). After adjusting for differences in case mix and for clustering in hospitals and matched pairs, the adjusted difference-in-differences model demonstrated a decrease in LOS by 1.1 days in the pilot over controls (P < .001). Conclusions and Relevance:Participating ERIN pilot hospitals achieved shorter LOS and decreased complications after elective colectomy, without increasing readmissions. The ability to implement ERPs across hospitals of varied size and resources is essential. Lessons from the ERIN pilot may inform efforts to scale this effective and evidence-based intervention.
| S-EPMC5933392 | biostudies-literature
Project description:BackgroundThe modern management of chronic pain is largely focused on improving functional capacity (often despite ongoing pain) by using graded activation and exposure paradigms. However, many people with chronic pain find functional activation programs aversive, and dropout rates are high. Modern technologies such as virtual reality (VR) could provide a more enjoyable and less threatening way for people with chronic pain to engage in physical activity. Although VR has been successfully used for pain relief in acute and chronic pain settings, as well as to facilitate rehabilitation in conditions such as stroke and cerebral palsy, it is not known whether VR can also be used to improve functional outcomes in people with chronic pain.ObjectiveThis study aimed to assess the feasibility of conducting an adequately powered randomized controlled trial (RCT) to test the efficacy of VR in a chronic pain treatment center and assess the acceptability of an active VR treatment program for patients in this setting.MethodsFor this mixed methods pilot study, which was designed to test the feasibility and acceptability of the proposed study methods, 29 people seeking treatment for chronic pain were randomized to an active VR intervention or physiotherapy treatment as usual (TAU). The TAU group completed a 6-week waitlist before receiving standard treatment to act as a no-treatment control group. The VR intervention comprised twice-weekly immersive and embodied VR sessions using commercially available gaming software, which was selected to encourage movement. A total of 7 VR participants completed semistructured interviews to assess their perception of the intervention.ResultsOf the 99 patients referred to physiotherapy, 53 (54%) were eligible, 29 (29%) enrolled, and 17 (17%) completed the trial, indicating that running an adequately powered RCT in this setting would not be feasible. Despite this, those in the VR group showed greater improvements in activity levels, pain intensity, and pain interference and reported greater treatment satisfaction and perceived improvement than both the waitlist and TAU groups. Relative effect sizes were larger when VR was compared with the waitlist (range small to very large) and smaller when VR was compared with TAU (range none to medium). The qualitative analysis produced the following three themes: VR is an enjoyable alternative to traditional physiotherapy, VR has functional and psychological benefits despite continued pain, and a well-designed VR setup is important.ConclusionsThe active VR intervention in this study was highly acceptable to participants, produced favorable effects when compared with the waitlist, and showed similar outcomes as those of TAU. These findings suggest that a confirmatory RCT is warranted; however, substantial barriers to recruitment indicate that incentivizing participation and using a different treatment setting or running a multicenter trial are needed.
| S-EPMC9330488 | biostudies-literature
Project description:Contrast-enhanced (CE) MRI was used to monitor breast cancer response to neoadjuvant chemotherapy. Patients underwent CE MRI before and after therapy, together with conventional assessment methods (CAM). CE MRI was carried out at 1.5 T in the coronal plain with 3D sequences before and after bolus injection. An expert panel determined chemotherapy response using both CE MRI and CAM. Histopathological response in the surgical specimen was then used to determine the sensitivity and specificity of CE MRI and CAM. In total, 67 patients with 69 breast cancers were studied (mean age of 46 years). Tumour characteristics showed a high-risk tumour population: median size 49 mm: histopathological grade 3 (55%): oestrogen receptor (ER) negative (48%). Histopathological response was as follows: - complete pathological response (pCR) 17%; partial response (pPR) 68%; no response (NR) 15%. Sensitivity of CAM for pCR or pPR was 98% (CI 91-100%) and specificity was 50% (CI 19-81%). CE MRI sensitivity was 100% (CI 94-100%), and specificity was 80% (CI 44-97%). The absolute agreement between assessment methods and histopathology was marginally higher for CE MRI than CAM (81 vs 68%; P=0.09). In 71%, CE MRI increased diagnostic knowledge, although in 20% it was judged confusing or incorrect. The 2nd MRI study significantly increased diagnostic confidence, and in 19% could have changed the treatment plan. CE MRI persistently underestimated minimal residual disease. In conclusion, CE MRI of breast cancer proved more reliable for predicting histopathological response to neoadjuvant chemotherapy than conventional assessment methods.
| S-EPMC2409692 | biostudies-other
Project description:BACKGROUND: Women in medicine report many gender-specific barriers to their career success and satisfaction, including a lack of mentors and role models. The literature calls for innovative strategies to enhance mentorship for women in medicine. OBJECTIVE: To describe the content, perceived value, and ongoing achievements of a mentoring program for women in emergency medicine. METHODS: The program offered mentoring for female faculty and residents in an academic emergency medicine department. Volunteers participated in group mentoring sessions using a mosaic of vertical and peer mentoring. Sessions focused on topics specific to women in medicine. An anonymous, electronic survey was sent to women who participated during 2004-2010 to assess the perceived value of the program and to collect qualitative feedback. Preliminary achievements fulfilling the program's goals were tracked. RESULTS: A total of 46 women (64%) completed the survey. The results showed a positive perceived value of the program (average, 4.65 on a 5-point Likert scale) in providing mentors and role models (4.41), in offering a supportive environment (4.39), in providing discussions pertinent to both personal (4.22) and professional development (4.22), while expanding networking opportunities (4.07). Notable achievements included work on the creation of a family leave policy, establishing lactation space, collaboration on projects, awards, and academic advancement. CONCLUSION: This innovative model for mentoring women is perceived as a valuable asset to the academic department and residency. It offers the unique combination of expanding a female mentor pool by recruiting alumni and using a mosaic of vertical and peer mentoring.
| S-EPMC3444192 | biostudies-other
Project description:ObjectivesTo evaluate adherence and acceptability of intermittent vaginal probiotic or antibiotic use to prevent bacterial vaginosis (BV) recurrence.DesignRepeated adherence and acceptability assessments using mixed methods within a pilot randomised controlled trial.SettingResearch clinic in Kigali, Rwanda.ParticipantsRwandan women with high sexual risk.InterventionsWomen diagnosed with BV and/or trichomoniasis were randomised to four groups (n=17 each) after completing metronidazole treatment: behavioural counselling only, or behavioural counselling plus 2-month intermittent use of oral metronidazole, Ecologic Femi+ (EF+) vaginal capsule or Gynophilus LP (GynLP) vaginal tablet.Outcome measuresAdherence and acceptability were assessed by structured face-to-face interviews, semi-structured focus group discussions and in-depth interviews, daily diaries and counting of used/unused study products in randomised women (n=68). Vaginal infection knowledge was assessed by structured face-to-face interviews in randomised women and women attending recruitment sessions (n=131).ResultsMost women (93%) were sex workers, 99.2% were unfamiliar with BV and none had ever used probiotics. All probiotic users (n=32) reported that insertion became easier over time. Triangulated adherence data showed that 17/17 EF+ users and 13/16 GynLP users used ≥80% of required doses (Fisher's exact p=0.103). Younger age (p=0.076), asking many questions at enrolment (p=0.116), having menses (p=0.104) and reporting urogenital symptoms (p=0.103) were non-significantly associated with lower perfect adherence. Women believed that the probiotics reduced BV recurrence, but reported that partners were sometimes unsupportive of study participation. Self-reported vaginal washing practices decreased during follow-up, but sexual risk behaviours did not. Most women (12/15) with an uncircumcised steady partner discussed penile hygiene with him, but many women found this difficult, especially with male clients.ConclusionsHigh-risk women require education about vaginal infections. Vaginal probiotic acceptability and adherence were high in this cohort. Our results can be used to inform future product development and to fine-tune counselling messages in prevention programmes.Trial registration numberNCT02459665.
| S-EPMC7247375 | biostudies-literature