Development and Preliminary Validation of the Chinese Version of the Totally Implantable Venous Access Port Self-Management Behavior Scale (CPTSMBS) for Patients with Cancer.

Objective: This study aimed to develop the Chinese version of the totally implantable venous access port (TIVAP) self-management behavior scale for patients with cancer to provide a reliable tool for medical staff to judge patients with TIVAP self-management behavior. Methods: This study employed a mixed-method exploratory design. The initial scale was developed through a literature review, expert meetings, and two-round Delphi expert consultation. The reliability indicators included retest reliability and Cronbach's alpha coefficients. The validity indicators included content, construct, convergent, discriminant, and criterion validity. Exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) were employed for the validity analysis; 22 venous therapy experts participated in the Delphi expert consultation. A total of 500 patients were recruited from two third-class A hospitals in Guangdong Province, China, between July 2020 and January 2021 to test reliability and validity. A convenience sampling method was adopted. Results: The final scale comprised seven dimensions and 29 items. The content validity index (S-CVI) was 0.990. Cronbach's alpha coefficient and retest reliability of the scale were 0.931 and 0.900, respectively. The EFA results indicated a seven-factor structure, accounting for 65.68% of the total data variance. The results of the CFA showed that the CMIN/DF value was 2.348; the root mean square error of approximation value was 0.06; and the values of comparative fit index, incremental fit index, and Tucker-Lewis index were all >0.90. The factor loadings for all the items were >0.50, the composite reliability value was >0.70, and the average variance extracted (AVE) value was >0.50. Moreover, all absolute values of the correlation coefficients were less than the square root of the AVE for the seven dimensions. The total scores between the health promoting lifestyle profile-II revise (HPLP-IIR) and CPTSMBS were positively correlated (r = 0.465, p < 0.01). Conclusion: The scale demonstrated good reliability and validity and can be applied in clinical practice to evaluate self-management behavior among patients using a TIVAP.

Construction of the structural equation model of stigma, self-disclosure, social support, and quality of life of breast cancer patients after surgery-a multicenter study.

Purpose: Stigma is common in patients with breast cancer after surgery, which has a negative impact on the quality of life (QOL). This study aimed to investigate the QOL of breast cancer patients after surgery and to analyze the multiple chains mediating effects of self-disclosure and social support between stigma and QOL. Methods: A total 292 patients of breast cancer patients after operation were recruited in this study. A questionnaire survey was conducted using the general information questionnaire, the consumer experiences of stigma questionnaire (CESQ), the distress disclosure index(DDI), the perceived social support scale(PSSS), and the functional assessment of cancer therapy-breast(FACT-B). Path analysis was conducted to test the hypothesized serial multiple mediation model. Results: The total scores of stigma, self-disclosure, social support and QOL were 15 (10 ~ 22), 39 (31 ~ 46), 58 (50 ~ 67) and 88 (74 ~ 104) respectively. QOL of breast cancer patients after the operation was negatively correlated with stigma (p < 0.01), and positively correlated with self-disclosure and social support (p < 0.01). Self-disclosure and social support played a complete mediating effect between stigma and QOL, and the total mediating effect value was 85. 87%. Conclusions: Self-disclosure and social support play a complete intermediary role between stigma and QOL. In order to improve the quality of life of patients, medical staff should pay attention to the assessment of stigma, encourage patients to express their emotions, and encourage their families and friends to respond to their expression and needs of patients.

Efficacy of Auricular Acupressure in Prevention and Treatment of Chemotherapy-Induced Nausea and Vomiting in Patients with Cancer: A Systematic Review and Meta-Analysis.

BACKGROUND: More than 40% of patients with cancer have reported that chemotherapy-induced nausea and vomiting (CINV) remained the most debilitating side effects of treatment even in the era of new antiemetics. OBJECTIVE: The purpose of this review was to systematically evaluate the clinical effect of auricular acupressure (AA) in prevention and treatment of chemotherapy-induced nausea and vomiting. METHODS: The following databases were searched: PubMed, Cochrane Library, EMBASE, the Web of Science, Chinese Biological Medicine (CBM), Chinese National Knowledge Infrastructure (CNKI), Wanfang, and VIP (from database inception to April 2020). Eligible randomized controlled trials of auricular acupressure in treating CINV were collected, including crossover randomized design study. The meta-analysis was carried out by RevMan software (5.3). RESULTS: Totally 19 RCTs with 1449 patients met the inclusion criteria. Compared with control groups, the relief efficiency of overall CINV was enhanced by AA combined with antiemetics (RR = 1.31, CI 1.22 to 1.41, p ≤ 0.001). Although the therapeutic effect on acute nausea and vomiting was not obvious, AA still played an important role in reducing delayed nausea and vomiting (delayed nausea frequency: RR = 0.68, CI -1.01 to -1.35, p ≤ 0.001; delayed vomiting frequency: RR = 0.91, CI -1.22 to -0.61, p ≤ 0.001). The likelihood of adverse reactions related to antiemetics was reduced by AA combined with antiemetics (RR = 0.62, CI 0.53 to 0.74, p ≤ 0.001). Statistically significant association was found between AA and incidence of constipation, diarrhea, and tiredness, while there was no statistically significant association between AA and abdominal distension or headache. CONCLUSION: Auricular acupressure supplementation benefited delayed chemotherapy-induced nausea and vomiting as well as constipation, diarrhea, and tiredness. AA alone or AA supplementation has little effect on acute nausea and acute vomiting. There is no conclusion on whether AA alone is superior to antiemetics in the management of delayed CINV. Further studies are needed to confirm the efficacy of auricular acupressure alone in delayed CINV and anticipatory CINV. The results of this review provided the basis for further research with more rigorous study designs, adequate sample sizes, and standardized implementation to confirm the efficacy of auricular acupressure.

Heparin versus 0.9% saline solution to maintain patency of totally implanted venous access ports in cancer patients: A systematic review and meta-analysis.

AIM: The use of heparin and 0.9% saline solution is always controversial for central venous catheters. However, there is no systematic review or guideline about whether saline solution can replace heparin solution in adult cancer patients with totally implantable venous access ports (TIVAPs). The purpose of this review is to evaluate whether saline solution can replace heparin saline to lock TIVAPs. METHODS: The following databases were searched: PubMed, the Cochrane Library, Web of Science, Embase, CINAHL and Ovid (January 1, 1982, and February 21, 2020). All statistical analyses of the meta-analysis were completed using the Review Manager 5.3. RESULTS: A total of 201 studies were identified from these databases after initial review, and four studies met inclusion criteria, including 2652 cases. There was little heterogeneity among the included studies (I2 < 30%), and all analyses were conducted by the fixed-effects model. The total complications, catheter occlusions, catheter-related bloodstream infections and other complication rates in the heparin solution group were higher than in the saline solution group. In the subgroup analysis of heparin concentration, total complication rates in the saline solution group were higher than with 50 U of heparin and lower than with 100 U of heparin. However, the differences in these complications were small, and no significant difference was observed (all P > 0.05). CONCLUSIONS: Based on existing clinical studies, we recommend that saline solution can replace 50 or 100 U/ml of heparin as a safe and effective flush solution for TIVAPs.

Prolonging the flush-lock interval of totally implantable venous access ports in patients with cancer: A systematic review and meta-analysis.

BACKGROUND: Recently, some studies have shown that prolonging flush interval is safe and feasible for patients who complete chemotherapy. However, there is no consensus about the optimal flush interval for those patients. OBJECTIVE: The purpose of this review was to evaluate whether the flush interval could be prolonged based on monthly interval for regular maintenance and to explore the optimal flush interval. DATA SOURCES: We searched the following databases for articles published between 1 January 1982 and 21 February 2020: PubMed, Cochrane Library, Web of Science, EMBASE, CINAHL, and Ovid. STUDY ELIGIBILITY CRITERIA: Randomized controlled trials, retrospective and prospective cohort studies of flush interval less than 4 weeks versus longer than 4 weeks for patients who completed chemotherapy, were included. RESULTS: Two reviewers extracted information and assessed the quality of the articles independently. In total, 389 articles were retrieved, and 4 studies including 862 cases fulfilled the inclusion criteria. There was no statistical heterogeneity (I2 = 0, p > 0.05) among the included studies. Hence, the fixed-effects model was used for the meta-analysis. The meta-analysis showed that the total complication rate associated with longer than 4-week interval was higher than that associated with less than 4-week interval. Nevertheless, there was no significant difference between the two groups (7.2% vs 7.6%, p = 0.83). Moreover, the meta-analysis showed that the total complication and catheter occlusion rates associated with the 4-week interval were higher than those associated with the 8-week interval. However, there was no significant difference between the two groups (total complications: 11.4% vs 9.5%, p = 0.68; catheter occlusions: 4.9% vs 4.1%, p = 0.89). LIMITATIONS: Only four non-randomized controlled studies were included, and the outcomes of the included studies were reported incompletely. CONCLUSION: Extending the flush interval to longer than 4 weeks is safe and feasible. Based on previous studies, extending the flush interval to 8 weeks might not increase the incidence of total complications and catheter occlusions. However, there is no conclusion on whether the flush interval could be extended to 3 months or longer.

Association between behavioral phenotypes and response to a physical activity intervention using gamification and social incentives: Secondary analysis of the STEP UP randomized clinical trial.

Participants often vary in their response to behavioral interventions, but methods to identify groups of participants that are more likely to respond are lacking. In this secondary analysis of a randomized clinical trial, we used baseline characteristics to group participants into distinct behavioral phenotypes and evaluated differential responses to a physical activity intervention. Latent class analysis was used to segment participants based on baseline participant data including demographics, validated measures of psychosocial variables, and physical activity behavior. The trial included 602 adults from 40 U.S. states with body mass index ≥25 who were randomized to control or one of three gamification interventions (supportive, collaborative, or competitive) to increase physical activity. Daily step counts were monitored using a wearable device for a 24-week intervention with 12 weeks of follow-up. The model segmented participants into three classes named for key defining traits: Class 1, extroverted and motivated; Class 2, less active and less social; Class 3, less motivated and at-risk. Adjusted regression models were used to test for differences in intervention response relative to control within each behavioral phenotype. In Class 1, only participants in the competitive arm increased their mean daily steps during the intervention (adjusted difference, 945; 95% CI, 352-1537; P = .002), but it was not sustained during follow-up. In Class 2, participants in all three gamification arms significantly increased their mean daily steps compared to control during the intervention (supportive arm adjusted difference 1172; 95% CI, 363-1980; P = .005; collaborative arm adjusted difference 1119; 95% CI, 319-1919; P = .006; competitive arm adjusted difference 1179; 95% CI, 400-1957; P = .003) and all three had sustained impact during follow-up. In Class 3, none of the interventions had a significant effect on physical activity. Three behavioral phenotypes were identified, each with a different response to the interventions. This approach could be used to better target behavioral interventions to participants that are more likely to respond to them.

A comparative study of patients' knowledge about hepatitis C in the United States and in urban and rural China.

BACKGROUND: Hepatitis C (HCV) is the predominant cause of chronic liver disease in the USA and is increasingly recognized as a common cause of liver disease in China. Studies of HCV patients in the US found major gaps in knowledge but little is known about HCV knowledge among patients in China. METHODS: We conducted a survey in three cohorts of HCV patients in Ann Arbor, MI, US, and in Beijing and Hebei, China, between April and November 2012 to compare patient knowledge about HCV in the US and in urban and rural China. RESULTS: A total of 525 patients (US 186; Beijing 186; Hebei 153) were enrolled. Mean ages of the three cohorts ranged from 52-56 years; 63% of US and 47% of Chinese patients were males; 63% of US and 39% of Beijing patients had college or postgraduate education compared to 0.7% in Hebei. More than half of the US and Beijing patients but only 13% of Hebei patients had received HCV treatment. The average HCV knowledge score out of a total of 16 in the US, Beijing, and Hebei was 12.7, 11.7, and 6.4, respectively (p < 0.001). Study site, education, gender, and prior HCV treatment were independent predictors of HCV knowledge. CONCLUSIONS: Knowledge about HCV in the US and Beijing patients was similar and significantly better than in Hebei patients. Our data show that efforts to improve HCV knowledge are necessary for all three cohorts and should be tailored to the education level and health literacy of the patients.

A comparative study of patients' attitudes toward clinical research in the United States and urban and rural China.

As the number of clinical trials conducted in China increases, understanding Chinese attitudes toward clinical research is critical for designing effective and ethical studies. Two survey studies were conducted in 2012 and 2013 to compare patient attitudes toward clinical research and factors affecting research participation in the United States and urban and rural China. We surveyed 525 patients in 2012 (186 US, 186 urban, 153 rural China) and 690 patients in 2013 (412 US, 206 urban, 72 rural China). US patients were more likely to have no concerns regarding research participation than Chinese patients. Most common concerns of US patients were safety, privacy and confidentiality, and time required. Safety was a top concern for many Chinese. Chinese patients, particularly rural Chinese, were more concerned about the likelihood of self-benefit, and receiving free medical care and financial incentive had greater influence on their participation. Being informed of the freedom to choose whether to participate or to leave a study was less important to Chinese patients. Our study provides important insights into Chinese patients' attitudes toward clinical research and the need to educate them about their rights. These findings help in designing cross-cultural clinical studies that maximize enrollment while upholding Western ethical standards.

Examining the evidence: a systematic review of the inclusion and analysis of older adults in randomized controlled trials.

BACKGROUND: Due to a shortage of studies focusing on older adults, clinicians and policy makers frequently rely on clinical trials of the general population to provide supportive evidence for treating complex, older patients. OBJECTIVES: To examine the inclusion and analysis of complex, older adults in randomized controlled trials. REVIEW METHODS: A PubMed search identified phase III or IV randomized controlled trials published in 2007 in JAMA, NEJM, Lancet, Circulation, and BMJ. Therapeutic interventions that assessed major morbidity or mortality in adults were included. For each study, age eligibility, average age of study population, primary and secondary outcomes, exclusion criteria, and the frequency, characteristics, and methodology of age-specific subgroup analyses were reviewed. RESULTS: Of the 109 clinical trials reviewed in full, 22 (20.2%) excluded patients above a specified age. Almost half (45.6%) of the remaining trials excluded individuals using criteria that could disproportionately impact older adults. Only one in four trials (26.6%) examined outcomes that are considered highly relevant to older adults, such as health status or quality of life. Of the 42 (38.5%) trials that performed an age-specific subgroup analysis, fewer than half examined potential confounders of differential treatment effects by age, such as comorbidities or risk of primary outcome. Trials with age-specific subgroup analyses were more likely than those without to be multicenter trials (97.6% vs. 79.1%, p < 0.01) and funded by industry (83.3% vs. 62.7%, p < 0.05). Differential benefit by age was found in seven trials (16.7%). CONCLUSION: Clinical trial evidence guiding treatment of complex, older adults could be improved by eliminating upper age limits for study inclusion, by reducing the use of eligibility criteria that disproportionately affect multimorbid older patients, by evaluating outcomes that are highly relevant to older individuals, and by encouraging adherence to recommended analytic methods for evaluating differential treatment effects by age.

Influence of dendrimer surface charge on the bioactivity of 2-methoxyestradiol complexed with dendrimers.

We report the complexation of a potential anticancer agent 2-methoxyestradiol (2-ME) with generation 5 (G5) poly(amidoamine) dendrimers having different surface functional groups for therapeutic applications. The complexation experiment shows that approximately 6-8 drug molecules can be complexed with one dendrimer molecule regardless the type of the dendrimer terminal groups. The bioactivity of 2-ME complexed with dendrimers was found to be significantly dependent on the surface charge of G5 dendrimers. In vitro cell biological assays show that amine, hydroxyl, and acetamide-terminated G5 dendrimers with positive, slightly positive, and close to neutral surface charges, respectively are able to deliver 2-ME to inhibit cancer cell growth. In contrast, 2-ME complexed with carboxyl-terminated G5 dendrimers with negative surface charges does not show its inherent bioactivity. Further molecular dynamics simulation studies show that the compact structure of carboxylated G5 dendrimers complexed with 2-ME does not allow the release of the drug molecules even at a pH of 5.0, which is the typical pH value in lysosome. Our findings indicate that the surface modification of dendrimers with different charges is crucial for the development of formulations of various anticancer drugs for therapeutic applications.

Targeting and detecting cancer cells using spontaneously formed multifunctional dendrimer-stabilized gold nanoparticles.

We develop a facile approach to fabricating multifunctional dendrimer-stabilized gold nanoparticles (Au DSNPs) for cancer cell targeting and imaging. In this work, amine-terminated generation 5 (G5) poly(amidoamine) (PAMAM) dendrimers pre-functionalized with folic acid (FA) and fluorescein isothiocyanate (FI) are complexed with Au(III) ions, followed by acetylation of the amine groups on the dendrimer surfaces. This one-step process leads to the spontaneous formation of 6 nm-sized Au nanoparticles stabilized by multifunctional dendrimers bearing both targeting and imaging functionalities. The multifunctional Au DSNPs are characterized by UV-Vis spectrometry, 1H NMR, and transmission electron microscopy (TEM). The formed Au DSNPs are water-soluble, stable, and biocompatible. Combined flow cytometry, confocal microscopy, silver staining, and inductively coupled plasma-mass spectrometry (ICP-MS) analyses show that the FA- and FI-functionalized Au DSNPs can specifically target to cancer cells expressing high-affinity FA receptors in vitro. This approach to functionalizing Au DSNPs may be extended to other targeting molecules, providing a unique nanoplatform for targeting and imaging of a variety of biological systems.

Multifunctional dendrimer-modified multiwalled carbon nanotubes: synthesis, characterization, and in vitro cancer cell targeting and imaging.

Carbon nanotubes hold great promise for their use as a platform in nanomedicine, especially in drug delivery, medical imaging, and cancer targeting and therapeutics. Herein, we present a facile approach to modifying carbon nanotubes with multifunctional poly(amidoamine) (PAMAM) dendrimers for cancer cell targeting and imaging. In this approach, fluorescein isothiocyanate (FI)- and folic acid (FA)-modified amine-terminated generation 5 (G5) PAMAM dendrimers (G5·NH(2)-FI-FA) were covalently linked to acid-treated multiwalled carbon nanotubes (MWCNTs), followed by acetylation of the remaining primary amine groups of the dendrimers. The resulting MWCNT/G5.NHAc-FI-FA composites are water-dispersible, stable, and biocompatible. In vitro flow cytometry and confocal microscopy data show that the formed MWCNT/G5·NHAc-FI-FA composites can specifically target to cancer cells overexpressing high-affinity folic acid receptors. The results of this study suggest that, through modification with multifunctional dendrimers, complex carbon nanotube-based materials can be fabricated, thereby providing many possibilities for various applications in biomedical sensing, diagnosis, and therapeutics.

Therapeutic efficacy of 2-methoxyestradiol microcrystals encapsulated within polyelectrolyte multilayers.

Development of a novel formulation of anticancer drugs to improve their water-solubility and bioavailability remains a great challenge. Herein, the potential anticancer agent 2-methoxyestradiol (2-ME) was selected as a model drug and was encapsulated within polyelectrolyte (PE) multilayers by layer-by-layer deposition of oppositely charged PEs onto the drug microcrystal surfaces. Cell viability and morphology observation of two cell lines reveal that the PE multilayer-encapsulated 2-ME microcrystals markedly decrease the cell viability, displaying similar inhibitory effect to that of the conventional formulation of 2-ME dissolved in ethanol. The current approach to encapsulate hydrophobic drug microparticles may be useful for formulating different drugs for a variety of biological applications.

Encapsulation of submicrometer-sized 2-methoxyestradiol crystals into polymer multilayer capsules for biological applications.

A facile approach has been developed to encapsulate submicrometer-sized drug crystals into polymer multilayer capsules produced by sequential deposition of polymers onto the drug particle surfaces. 2-Methoxyestradiol (2-ME) is a hydrophobic metabolite of 17-beta estradiol, which has been demonstrated as a potential anticancer agent. It was selected as a model drug and was formulated into submicrometer-sized particles through fine milling followed by intense sonication in the presence of dipalmitoyl-dl-(R)-phosphatidylcholine (DPPC). The reserved positive charges on the 2-ME crystal surface by DPPC enhanced the water solubility of the particles and subsequent self-assembly of dextran sulfate (DS) and dextran (DN) multilayers through hydrogen bonding and physical adsorption. Upon the exposure of the drug capsules to ethanol, hollow DS/DN multilayer polymer shells can be formed. The encapsulation process and hollow polymer multilayer shell formation were confirmed by confocal laser scanning microscopy (CLSM) and transmission electron microscopy (TEM), while the surface morphology of the formed drug capsules was investigated using scanning electron microscopy (SEM). In vitro studies show that the inhibitory effect of the formed 2-ME capsules is the same as that of the conventional formulation of 2-ME in a concentrated ethanol solution, as demonstrated by dramatic changes in cell morphology and significantly decreased viability of target cells. We also demonstrate that the change of the outermost layer of the drug capsules does not significantly influence its bioactivity. The presented strategy to encapsulate submicrometer-sized hydrophobic drug particles is expected to provide a general pathway to fabricate drug capsules for various biological applications.