Mobile-Web App to Self-Manage Low Back Pain: Randomized Controlled Trial

Background

Nonspecific low back pain (NLBP) is the diagnosis for individuals with back pain that has no underlying medical cause (eg, tumor, infection, fracture, herniated disc, spinal stenosis). The American College of Physicians (ACP) and American Pain Society (APS) recommend multidisciplinary treatments for NLBP that lasts more than 4 weeks. This approach, however, is impractical for many physicians to implement, and relatively few providers offer NLBP treatment that meets the joint ACP-APS guidelines.

Objective

This study evaluated the efficacy of a mobile-Web intervention called “FitBack” to help users implement self-tailored strategies to manage and prevent NLBP occurrences.

Methods

A total of 597 adults were recruited, screened, consented, and assessed online at baseline, at 2 months (T2), and at 4 months (T3). After baseline assessments, participants were randomized into three groups: FitBack intervention, alternative care group that received 8 emails urging participants to link to six Internet resources for NLBP, and control group. The FitBack group also received weekly email reminder prompts for 8 weeks plus emails to do assessments. The control group was only contacted to do assessments.

Results

Users of the FitBack program showed greater improvement compared to the control group in every comparison of the critical physical, behavioral, and worksite outcome measures at 4-month follow-up. In addition, users of the FitBack program performed better than the alternative care group on current back pain, behavioral, and worksite outcomes at 4-month follow-up. For example, subjects in the control group were 1.7 times more likely to report current back pain than subjects in the FitBack group; subjects in the alternative care group were 1.6 times more likely to report current back pain at 4-month follow-up. Further, the users of the FitBack program showed greater improvement compared to both the control and alternative care groups at 4-month follow-up on patient activation, constructs of the Theory of Planned Behavior, and attitudes toward pain.

Conclusions

This research demonstrated that a theoretically based stand-alone mobile-Web intervention that tailors content to users’ preferences and interests can be an effective tool in self-management of low back pain. When viewed from the RE-AIM perspective (ie, reach, efficacy/effectiveness, adoption, implementation fidelity, and maintenance), this study supports the notion that there is considerable value in this type of intervention as a potentially cost-effective tool that can reach large numbers of people. The results are promising considering that the FitBack intervention was neither supported by professional caregivers nor integrated within a health promotion campaign, which might have provided additional support for participants. Still, more research is needed on how self-guided mobile-Web interventions will be used over time and to understand factors associated with continuing user engagement.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01950091","term_id":"NCT01950091"}}NCT01950091; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01950091","term_id":"NCT01950091"}}NCT01950091 (Archived by WebCite at http://www.webcitation.org/6TwZucX77).     

Daily Collection of Self-Reporting Sleep Disturbance Data via a Smartphone App in Breast Cancer Patients Receiving Chemotherapy: A Feasibility Study

Background

Improvements in mobile telecommunication technologies have enabled clinicians to collect patient-reported outcome (PRO) data more frequently, but there is as yet limited evidence regarding the frequency with which PRO data can be collected via smartphone applications (apps) in breast cancer patients receiving chemotherapy.

Objective

The primary objective of this study was to determine the feasibility of an app for sleep disturbance-related data collection from breast cancer patients receiving chemotherapy. A secondary objective was to identify the variables associated with better compliance in order to identify the optimal subgroups to include in future studies of smartphone-based interventions.

Methods

Between March 2013 and July 2013, patients who planned to receive neoadjuvant chemotherapy for breast cancer at Asan Medical Center who had access to a smartphone app were enrolled just before the start of their chemotherapy and asked to self-report their sleep patterns, anxiety severity, and mood status via a smartphone app on a daily basis during the 90-day study period. Push notifications were sent to participants daily at 9 am and 7 pm. Data regarding the patients’ demographics, interval from enrollment to first self-report, baseline Beck’s Depression Inventory (BDI) score, and health-related quality of life score (as assessed using the EuroQol Five Dimensional [EQ5D-3L] questionnaire) were collected to ascertain the factors associated with compliance with the self-reporting process.

Results

A total of 30 participants (mean age 45 years, SD 6; range 35-65 years) were analyzed in this study. In total, 2700 daily push notifications were sent to these 30 participants over the 90-day study period via their smartphones, resulting in the collection of 1215 self-reporting sleep-disturbance data items (overall compliance rate=45.0%, 1215/2700). The median value of individual patient-level reporting rates was 41.1% (range 6.7-95.6%). The longitudinal day-level compliance curve fell to 50.0% at day 34 and reached a nadir of 13.3% at day 90. The cumulative longitudinal compliance curve exhibited a steady decrease by about 50% at day 70 and continued to fall to 45% on day 90. Women without any form of employment exhibited the higher compliance rate. There was no association between any of the other patient characteristics (ie, demographics, and BDI and EQ5D-3L scores) and compliance. The mean individual patient-level reporting rate was higher for the subgroup with a 1-day lag time, defined as starting to self-report on the day immediately after enrollment, than for those with a lag of 2 or more days (51.6%, SD 24.0 and 29.6%, SD 25.3, respectively; P=.03).

Conclusions

The 90-day longitudinal collection of daily self-reporting sleep-disturbance data via a smartphone app was found to be feasible. Further research should focus on how to sustain compliance with this self-reporting for a longer time and select subpopulations with higher rates of compliance for mobile health care.     

Physical Activity in First-Degree Relatives of Breast Cancer Patients

This study sought to evaluate physical activity in women at moderate risk for breast cancer, the correlates of engaging in regular physical activity, and whether physical activity relates to psychological well-being. The results revealed that 55% of women were regularly active. Logistic regression models indicated that positive affect was associated with increased and negative affect was associated with decreased overall and leisure activity. Older, married, and employed women were more likely to engage in household/occupational activity, whereas women who perceived their risk for breast cancer as high were less likely. More educated women and those with higher perceived risk were more likely to engage in leisure activity, and married women were less likely. These results suggest a need to increase activity levels in women at moderate risk for breast cancer, provide variables upon which interventions can be tailored to promote activity, and point to psychological benefits of activity in this population.     

App Usage Factor: A Simple Metric to Compare the Population Impact of Mobile Medical Apps

Background

One factor when assessing the quality of mobile apps is quantifying the impact of a given app on a population. There is currently no metric which can be used to compare the population impact of a mobile app across different health care disciplines.

Objective

The objective of this study is to create a novel metric to characterize the impact of a mobile app on a population.

Methods

We developed the simple novel metric, app usage factor (AUF), defined as the logarithm of the product of the number of active users of a mobile app with the median number of daily uses of the app. The behavior of this metric was modeled using simulated modeling in Python, a general-purpose programming language. Three simulations were conducted to explore the temporal and numerical stability of our metric and a simulated app ecosystem model using a simulated dataset of 20,000 apps.

Results

Simulations confirmed the metric was stable between predicted usage limits and remained stable at extremes of these limits. Analysis of a simulated dataset of 20,000 apps calculated an average value for the app usage factor of 4.90 (SD 0.78). A temporal simulation showed that the metric remained stable over time and suitable limits for its use were identified.

Conclusions

A key component when assessing app risk and potential harm is understanding the potential population impact of each mobile app. Our metric has many potential uses for a wide range of stakeholders in the app ecosystem, including users, regulators, developers, and health care professionals. Furthermore, this metric forms part of the overall estimate of risk and potential for harm or benefit posed by a mobile medical app. We identify the merits and limitations of this metric, as well as potential avenues for future validation and research.     

Effectiveness of a Web- and Mobile Phone-Based Intervention to Promote Physical Activity and Healthy Eating in Middle-Aged Males: Randomized Controlled Trial of the ManUp Study

Background

The high number of adult males engaging in low levels of physical activity and poor dietary practices, and the health risks posed by these behaviors, necessitate broad-reaching intervention strategies. Information technology (IT)-based (Web and mobile phone) interventions can be accessed by large numbers of people, yet there are few reported IT-based interventions targeting males’ physical activity and dietary practices.

Objective

This study examines the effectiveness of a 9-month IT-based intervention (ManUp) to improve the physical activity, dietary behaviors, and health literacy in middle-aged males compared to a print-based intervention.

Methods

Participants, recruited offline (eg, newspaper ads), were randomized into either an IT-based or print-based intervention arm on a 2:1 basis in favor of the fully automated IT-based arm. Participants were adult males aged 35-54 years living in 2 regional cities in Queensland, Australia, who could access the Internet, owned a mobile phone, and were able to increase their activity level. The intervention, ManUp, was based on social cognitive and self-regulation theories and specifically designed to target males. Educational materials were provided and self-monitoring of physical activity and nutrition behaviors was promoted. Intervention content was the same in both intervention arms; only the delivery mode differed. Content could be accessed throughout the 9-month study period. Participants’ physical activity, dietary behaviors, and health literacy were measured using online surveys at baseline, 3 months, and 9 months.

Results

A total of 301 participants completed baseline assessments, 205 in the IT-based arm and 96 in the print-based arm. A total of 124 participants completed all 3 assessments. There were no significant between-group differences in physical activity and dietary behaviors (P≥.05). Participants reported an increased number of minutes and sessions of physical activity at 3 months (exp(β)=1.45, 95% CI 1.09-1.95; exp(β)=1.61, 95% CI 1.17-2.22) and 9 months (exp(β)=1.55, 95% CI 1.14-2.10; exp(β)=1.51, 95% CI 1.15-2.00). Overall dietary behaviors improved at 3 months (exp(β)=1.07, 95% CI 1.03-1.11) and 9 months (exp(β)=1.10, 95% CI 1.05-1.13). The proportion of participants in both groups eating higher-fiber bread and low-fat milk increased at 3 months (exp(β)=2.25, 95% CI 1.29-3.92; exp(β)=1.65, 95% CI 1.07-2.55). Participants in the IT-based arm were less likely to report that 30 minutes of physical activity per day improves health (exp(β)=0.48, 95% CI 0.26-0.90) and more likely to report that vigorous intensity physical activity 3 times per week is essential (exp(β)=1.70, 95% CI 1.02-2.82). The average number of log-ins to the IT platform at 3 and 9 months was 6.99 (SE 0.86) and 9.22 (SE 1.47), respectively. The average number of self-monitoring entries at 3 and 9 months was 16.69 (SE 2.38) and 22.51 (SE 3.79), respectively.

Conclusions

The ManUp intervention was effective in improving physical activity and dietary behaviors in middle-aged males with no significant differences between IT- and print-based delivery modes.

Trial Registration

Australian New Zealand Clinical Trials Registry: ACTRN12611000081910; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000081910 (Archived by WebCite at http://www.webcitation.org/6QHIWad63).     

The Effect of Credibility-Related Design Cues on Responses to a Web-Based Message About the Breast Cancer Risks From Alcohol: Randomized Controlled Trial

Background

Internet sites typically contain visual design elements that are unrelated to the quality of the health information presented but that could influence credibility judgments and responses to health advice. To assess the effects of such design elements, or credibility cues, experimentally, we exposed women with different levels of weekly alcohol consumption to a website containing high quality but unpalatable information about a related health risk (breast cancer). The information was presented alongside either positive or negative credibility cues unrelated to information content.

Objectives

We explored four research questions: (1) Did the cues influence how the women engaged with the site? (2) Did they influence how the women responded cognitively and emotionally? (3) Did they influence whether the women subsequently acted on the advice? (4) Did the impact of the cues vary with how much alcohol the women reported drinking?

Method

A total of 85 women were randomly assigned to view one of two versions of a website containing the same high-quality content but different cues. One version had positive credibility cues (trustmarks), the other had negative ones (adverts, pharmaceutical sponsorship, and a donation button). Objective measures included visual attention (using eye-tracking equipment), time studying the material, and recall. Subjective measures included cognitive and affective responses and intention to change. Measures of subsequent behavior were taken 1 week later.

Results

First, the cues did not affect how long the women spent on the site or how long they spent reading the text. However, women in the negative cues condition spent more time looking at a donation button than those in the positive cues condition spent looking at a TRUSTe seal (β = −.43, P < .001) but less time looking at a logo (β = .43, P < .001) or at certain other features of the site. Those in the negative cues condition also recalled more site content (β = −.22, P = .048). Second, there were no effects of the cues on any of the measures of cognition, affect, vulnerability, or intentions. However, third, at follow-up, the positive cues had promoted greater alcohol reduction than the negative cues among those women who had previously reported drinking more heavily (β = −.22, P = .02). So, fourth, the responses to the cues did vary with how much alcohol the women typically drank.

Conclusions

Content-irrelevant images and logos can influence the behavioral response to quality health-risk information. These effects may be subtle, changing with time.     

Development and Assessment of an E-Learning Course on Breast Imaging for Radiographers: A Stratified Randomized Controlled Trial

Background

Mammography is considered the best imaging technique for breast cancer screening, and the radiographer plays an important role in its performance. Therefore, continuing education is critical to improving the performance of these professionals and thus providing better health care services.

Objective

Our goal was to develop an e-learning course on breast imaging for radiographers, assessing its efficacy, effectiveness, and user satisfaction.

Methods

A stratified randomized controlled trial was performed with radiographers and radiology students who already had mammography training, using pre- and post-knowledge tests, and satisfaction questionnaires. The primary outcome was the improvement in test results (percentage of correct answers), using intention-to-treat and per-protocol analysis.

Results

A total of 54 participants were assigned to the intervention (20 students plus 34 radiographers) with 53 controls (19+34). The intervention was completed by 40 participants (11+29), with 4 (2+2) discontinued interventions, and 10 (7+3) lost to follow-up. Differences in the primary outcome were found between intervention and control: 21 versus 4 percentage points (pp), P<.001. Stratified analysis showed effect in radiographers (23 pp vs 4 pp; P=.004) but was unclear in students (18 pp vs 5 pp; P=.098). Nonetheless, differences in students’ posttest results were found (88% vs 63%; P=.003), which were absent in pretest (63% vs 63%; P=.106). The per-protocol analysis showed a higher effect (26 pp vs 2 pp; P<.001), both in students (25 pp vs 3 pp; P=.004) and radiographers (27 pp vs 2 pp; P<.001). Overall, 85% were satisfied with the course, and 88% considered it successful.

Conclusions

This e-learning course is effective, especially for radiographers, which highlights the need for continuing education.     

Motivational Interviewing in a Web-Based Physical Activity Intervention With an Avatar: Randomized Controlled Trial

Background

Developing Web-based physical activity (PA) interventions based on motivational interviewing (MI) could increase the availability and reach of MI techniques for PA promotion. Integrating an avatar in such an intervention could lead to more positive appreciation and higher efficacy of the intervention, compared to an intervention that is purely text-based.

Objective

The present study aims to determine whether a Web-based PA intervention based on MI with an avatar results in more positive appreciation and higher effectiveness of the intervention, when compared to an intervention that is purely text-based.

Methods

A three-arm randomized controlled trial was conducted, containing the following research conditions: (1) a Web-based PA intervention based on MI with an avatar, (2) a content-identical intervention without an avatar, and (3) a control condition that received no intervention. Measurements included PA behavior and process variables, measured at baseline, directly following the intervention and 1 month post intervention.

Results

Both interventions significantly increased self-reported PA at 1 month, compared to the control condition (beta_{AVATARvsCONTROL}=.39, P=.011; beta_{TEXTvsCONTROL}=.44, P=.006). No distinctions were found regarding intervention effect on PA between both interventions. Similarly, the results of the process evaluation did not indicate any significant differences between both interventions. Due to the limited relational skills of the avatar in this study, it probably did not succeed in forming a stronger relationship with the user, over and above text alone.

Conclusions

The findings suggest that avatars that do not strengthen the social relationship with the user do not enhance the intervention impact. Future research should determine whether Web-based PA interventions based on MI could benefit from inclusion of a virtual coach capable of more complex relational skills than used in the current study, such as responding in gesture to the user’s state and input.

Trial Registration

Dutch Trial Register trial number: NTR3147; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3147 (Archived by WebCite at http://www.webcitation.org/6NCbwdUJX).     

The Impact of a Web-Based App (eBalance) in Promoting Healthy Lifestyles: Randomized Controlled Trial

BackgroundThe use of Web-based apps to promote a healthy lifestyle is increasing, although most of these programs were not assessed using suitable epidemiological methods. We evaluated the effectiveness of a newly developed Web-based app in promoting a healthy lifestyle and educating adults on such lifestyles. We also analyzed predictors for success in acquiring and maintaining a healthy lifestyle.ObjectiveOur aim was to compare people receiving a new Web-based app with people who got an introductory lecture alone on healthy lifestyle, weight change, nutritional knowledge, and physical activity, and to identify predictors of success for maintaining a healthy lifestyle.MethodsSubjects were recruited from the community and were randomized into intervention and control groups. The intervention subjects received access to the app without any face-to-face support; the control subjects continued their standard lifestyle. Measurements were taken by the researcher at baseline and after 14 weeks and included weight and waist circumference. Nutritional knowledge, diet quality, and physical activity duration were obtained using online questionnaires. The new Web-based app was developed based on current US Department of Agriculture and Israel Ministry of Health recommendations for healthy lifestyle. The app provides tools for monitoring diet and physical activity while instructing and encouraging healthy diet and physical activity.ResultsOut of 99 subjects who were randomized into app and control groups, 85 participants (86%) completed the study, 56 in the intervention and 29 in the control group. The mean age was 47.9 (SD 12.3) years, and mean Body Mass Index was 26.2 (SD 3.9). Among the intervention group only, frequency of app use was 2.7 (SD 1.9) days/week. The mean change in physical activity was 63 (SD 20.8) minutes in the app group and -30 (SD 27.5) minutes in the control group (P=.02). The mean weight change was -1.44 (SD 0.4) kg in the app group and -0.128 (SD 0.36) kg in the control group (P=.03). Knowledge score increased significantly in the app group, 76 (SD 7.5) to 79 (SD 8.7) at the end of the study (P=.04) compared with the control group. Diet quality score also increased significantly at the end of the study, from 67 (SD 9.8) to 71 (SD 7.6; P<.001) in contrast to the control group. Success score (represents the success in maintaining healthy lifestyle) was higher among the app group (68%) compared with 36% in the control group (P<.001). The app frequency of use was significantly related to a higher success score (P<.001).ConclusionsWe showed a positive impact of a newly developed Web-based app on lifestyle indicators during an intervention of 14 weeks. These results are promising in the app’s potential to promote a healthy lifestyle, although larger and longer duration studies are needed to achieve more definitive conclusions.

Trial Registration

Clinicaltrial.gov number: {"type":"clinical-trial","attrs":{"text":"NCT01913496","term_id":"NCT01913496"}}NCT01913496; http://www.clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01913496","term_id":"NCT01913496"}}NCT01913496 (Archived by WebCite at http://www.webcitation.org/6WSTUEPuJ).     

Effectiveness of a Web-Based Physical Activity Intervention in Patients With Knee and/or Hip Osteoarthritis: Randomized Controlled Trial

Background

Patients with knee and/or hip osteoarthritis (OA) are less physically active than the general population, while the benefits of physical activity (PA) have been well documented. Based on the behavioral graded activity treatment, we developed a Web-based intervention to improve PA levels in patients with knee and/or hip OA, entitled “Join2move”. The Join2move intervention is a self-paced 9-week PA program in which the patient’s favorite recreational activity is gradually increased in a time-contingent way.

Objective

The aim of the study was to investigate whether a fully automated Web-based PA intervention in patients with knee and/or hip OA would result in improved levels of PA, physical function, and self-perceived effect compared with a waiting list control group.

Methods

The study design was a two-armed randomized controlled trial which was not blinded. Volunteers were recruited via articles in newspapers and health-related websites. Eligibility criteria for participants were: (1) aged 50-75 years, (2) self-reported knee and/or hip OA, (3) self-reported inactivity (30 minutes of moderate PA, 5 times or less per week), (4) no face-to-face consultation with a health care provider other than general practitioners, for OA in the last 6 months, (5) ability to access the Internet weekly, and (6) no contra-indications to exercise without supervision. Baseline, 3-month, and 12-month follow-up data were collected through online questionnaires. Primary outcomes were PA, physical function, and self-perceived effect. In a subgroup of participants, PA was measured objectively using accelerometers. Secondary outcomes were pain, fatigue, anxiety, depression, symptoms, quality of life, self-efficacy, pain coping, and locus of control.

Results

Of the 581 interested respondents, 199 eligible participants were randomly assigned to the intervention (n=100) or waiting list control group (n=99). Response rates of questionnaires were 84.4% (168/199) after 3 months and 75.4% (150/199) after 12 months. In this study, 94.0% (94/100) of participants actually started the program, and 46.0% (46/100) reached the adherence threshold of 6 out of 9 modules completed. At 3 months, participants in the intervention group reported a significantly improved physical function status (difference=6.5 points, 95% CI 1.8-11.2) and a positive self-perceived effect (OR 10.7, 95% CI 4.3-26.4) compared with the control group. No effect was found for self-reported PA. After 12 months, the intervention group showed higher levels of subjective (difference=21.2 points, 95% CI 3.6-38.9) and objective PA (difference=24 minutes, 95% CI 0.5-46.8) compared with the control group. After 12 months, no effect was found for physical function (difference=5 points, 95% CI −1.0 to 11.0) and self-perceived effect (OR 1.2, 95% CI 0.6-2.4). For several secondary endpoints, the intervention group demonstrated improvements in favor of the intervention group.

Conclusions

Join2move resulted in changes in the desired direction for several primary and secondary outcomes. Given the benefits and its self-help format, Join2move could be a component in the effort to enhance PA in sedentary patients with knee and/or hip OA.

Trial Registration

The Netherlands National Trial Register: NTR2483; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2483 (Archived by WebCite at http://www.webcitation.org/67NqS6Beq).     

Brief Report: An Intervention Program for Parents of Pediatric Cancer Patients: A Randomized Controlled Trial

Objective: To evaluate a psychoeducational intervention programfor parents of pediatric cancer patients, using cognitive andbehavioral techniques. Methods: Parents were randomly assigned to an intervention (n= 39) and a control condition (n = 42). Baseline assessmenttook place at diagnosis. Short-term effects were measured immediatelyafter the intervention, long-term effects six months later.Control parents received standard care. Intervention parentsreceived, in addition, a manual-guided program during the firstsix months following the diagnosis. Results: With time all parents became significantly less psychologicallydistressed. However, no between-group differences were notedin psychological functioning, satisfaction with support, andintensity of emotions immediately postintervention and six monthslater. Conclusions: Although the clinical evaluation of the interventionwas positive, it appeared that a structured intervention programas described in this study was not any more effective than standardcare.     

Functional Analysis of Missense Variants in the Putative Breast Cancer Susceptibility Gene XRCC2

XRCC2 genetic variants have been associated with breast cancer susceptibility. However, association studies have been complicated because XRCC2 variants are extremely rare and consist mainly of amino acid substitutions whose grouping is sensitive to misclassification by the predictive algorithms. We therefore functionally characterized variants in XRCC2 by testing their ability to restore XRCC2‐DNA repair deficient phenotypes using a cDNA‐based complementation approach. While the protein‐truncating variants p.Leu117fs, p.Arg215*, and p.Cys217* were unable to restore XRCC2 deficiency, 19 out of 23 missense variants showed no or just a minor (<25%) reduction in XRCC2 function. The remaining four (p.Cys120Tyr, p.Arg91Trp, p.Leu133Pro, and p.Ile95Leu) had a moderate effect. Overall, measured functional effects correlated poorly with those predicted by in silico analysis. After regrouping variants from published case‐control studies based on the functional effect found in this study and reanalysis of the prevalence data, there was no longer evidence for an association with breast cancer. This suggests that if breast cancer susceptibility alleles of XRCC2 exist, they are likely restricted to protein‐truncating variants and a minority of missense changes. Our study emphasizes the use of functional analyses of missense variants to support variant classification in association studies.     

Cardiovascular Health Effects of Internet-Based Encouragements to Do Daily Workplace Stair-Walks: Randomized Controlled Trial

Background

Although the hazardous health effects of a sedentary lifestyle are well known, many adults struggle with regular physical activity. Simple and efficient encouragements for increased physical activity are needed.

Objective

To determine the effect on cardiovascular health of email-based encouragements to do daily stair-walks at work together with colleagues among adults in sedentary occupations.

Methods

A single-blind randomized controlled trial was performed at a large administrative company in Copenhagen, Denmark. Participants were 160 office workers (125 women, 35 men; mean age 42 years, SD 10; sitting 89.5% of work time). At baseline, aerobic fitness was 37 mL/min/kg (SD 9), mean blood pressure was 118/79 mmHg (SD 14/9), and mean body mass index (BMI) was 23 kg/m² (SD 4). Participants were randomly assigned (2:1 ratio) to an email group receiving weekly email-based encouragements to walk the stairs for 10 minutes a day or to a control group receiving weekly reminders to continue their usual physical activities. The primary outcome was the change from baseline to 10-week follow-up in aerobic fitness determined from a maximal cycle test. The examiner was blinded to group allocation.

Results

Adherence to the email encouragements was fairly high with 82.7% of the participants performing at least 3 sessions of 10-minute stair-walks per week (mean 3.3, SD 1.3). Mean heart rate reached 167 beats/min (SD 10) during stair-walks. In the intention-to-treat analysis, aerobic fitness increased 1.45 mL/min/kg (95% CI 0.64-2.27) at 10-week follow-up in the email group compared with the control group. In participants with low aerobic fitness at baseline (n=56), aerobic fitness increased 1.89 mL/min/kg (95% CI 0.53-3.24), and systolic and diastolic blood pressure decreased 4.81 mmHg (95% CI 0.47-9.16) and 2.67 mmHg (95% CI 0.01-5.32), respectively, in the email group compared with the control group. Body weight decreased in the email group of those with low aerobic fitness compared with the control group, but this was not statistically significant.

Conclusions

Simple and inexpensive email-based encouragements to do daily stair-walks together with colleagues at work improves cardiovascular health among adults in sedentary occupations. There exists an enormous potential to prevent the hazardous health effects of a sedentary lifestyle through the use of email-based encouragements to do short bouts of physical activity at the workplace.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01293253","term_id":"NCT01293253"}}NCT01293253; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01293253","term_id":"NCT01293253"}}NCT01293253 (Archived by WebCite at http://www.webcitation.org/6HWG2jw68).     

Absence of T Cell-Mediated Cytotoxicity in Breast Cancer Patients Against A Breast Cancer-Derived Target Cell

ABSTRACT: Fresh E-rosette positive lymphocytes from normal donors are not cytotoxic for the breast cancer-derived target cell MDA-157, although they do lyse other suspension and monolayer targets. E-rosette positive cells from breast cancer patients in different stages of disease and from patients with benign breast disease also do not lyse MDA-157. This remains true even when an HLA-A or -B locus antigen is shared by effector and target cell. These data therefore provide no evidence for T cell sensitization in breast cancer patients.     

乳腺癌患者血清Leptin水平检测及其临床意义

目的:研究瘦素(Leptin)对乳腺癌诊断的价值,为乳腺癌与乳腺良性病变的鉴别诊断提供实验依据。方法:应用放射免疫分析(RIA)分别检测46例乳腺癌、28例乳腺良性病变患者及41例正常对照组外周血中Leptin含量。结果:乳腺癌组病人血中Leptin含量(21.97±9.13ng/ml)明显高于乳腺良性病变组(16.78±5.13ng/ml)及正常对照组(12.25±2.39ng/ml),差别有显著性(P<0.01)。随着乳腺癌病情的进展,从乳腺癌Ⅰ期至Ⅳ期,Leptin水平逐渐升高,有显著性差异(P<0.01)。乳腺癌淋巴有转移组Leptin水平(26.29±8.83ng/ml),明显高于乳腺癌无淋巴转移组(16.35±6ng/ml),差异有显著性(P<0.01)。结论:Leptin的检测可作为乳腺癌诊断的实验室指标,对乳腺癌的分期和预后的评价有重要价值,对治疗方案的选择有重要的指导意义。     

Comparing Effects in Regular Practice of E-Communication and Web-Based Self-Management Support Among Breast Cancer Patients: Preliminary Results From a Randomized Controlled Trial

BackgroundWhile Web-based interventions have been shown to assist a wide range of patients successfully in managing their illness, few studies have examined the relative contribution of different Web-based components to improve outcomes. Further efficacy trials are needed to test the effects of Web support when offered as a part of routine care.ObjectiveOur aim was to compare in regular care the effects of (1) an Internet-based patient provider communication service (IPPC), (2) WebChoice, a Web-based illness management system for breast cancer patients (IPPC included), and (3) usual care on symptom distress, anxiety, depression, (primary outcomes), and self-efficacy (secondary outcome). This study reports preliminary findings from 6 months’ follow-up data in a 12-month trial.MethodsWe recruited 167 patients recently diagnosed with breast cancer and undergoing treatment from three Norwegian hospitals. The nurse-administered IPPC allowed patients to send secure e-messages to and receive e-messages from health care personnel at the hospital where they were treated. In addition to the IPPC, WebChoice contains components for symptom monitoring, tailored information and self-management support, a diary, and communication with other patients. A total of 20 care providers (11 nurses, 6 physicians, and 3 social workers) were trained to answer questions from patients. Outcomes were measured with questionnaires at study entry and at study months 2, 4, and 6. Linear mixed models for repeated measures were fitted to compare effects on outcomes over time.ResultsPatients were randomly assigned to the WebChoice group (n=64), the IPPC group (n=45), or the usual care group (n=58). Response rates to questionnaires were 73.7% (123/167) at 2 months, 65.9 (110/167) at 4 months, and 62.3% (104/167) at 6 months. Attrition was similar in all study groups. Among those with access to WebChoice, 64% (41/64) logged on more than once and 39% (25/64) sent e-messages to care providers. In the IPPC group, 40% (18/45) sent e-messages. Linear mixed models analyses revealed that the WebChoice group reported significantly lower symptom distress (mean difference 0.16, 95% CI 0.06-0.25, P=.001), anxiety (mean difference 0.79, 95% CI 0.09-1.49, P=.03), and depression (mean difference 0.79, 95% CI 0.09-1.49, P=.03) compared with the usual care group. The IPPC group reported significant lower depression scores compared with the usual care group (mean difference 0.69, 95% CI 0.05-1.32, P=.03), but no differences were observed for symptom distress or anxiety. No significant differences in self-efficacy were found among the study groups.ConclusionsIn spite of practice variations and moderate use of the interventions, our results suggest that offering Web support as part of regular care can be a powerful tool to help patients manage their illness. Our finding that a nurse-administered IPPC alone can significantly reduce depression is particularly promising. However, the multicomponent intervention WebChoice had additional positive effects.

Trial Registration

Clinicaltrials.gov:{"type":"clinical-trial","attrs":{"text":"NCT00971009","term_id":"NCT00971009"}}NCT00971009; http://clinicaltrials.gov/show/{"type":"clinical-trial","attrs":{"text":"NCT00971009","term_id":"NCT00971009"}}NCT00971009 (Archived by WebCite at http://www.webcitation.org/6USKezP0Y).     

长春瑞滨联合顺铂治疗中晚期乳腺癌的临床观察

目的 观察长春瑞滨(盖诺)联合顺铂方案治疗中晚期乳腺癌的临床疗效.方法 运用盖诺(25mg/m2IVD d1,d8)加顺铂(DDP 80mg/m2IV d1)治疗中晚期乳腺癌36例.结果 总有效率达66.7%.主要不良反应为骨髓抑制.胃肠道反应和静脉炎.白细胞减少的发生率100%.其中Ⅲ-Ⅳ度达55.6%.恶心、呕吐的发生率92.3%,Ⅲ-Ⅳ度达11.1%.静脉炎的发生率11.1%.结论 国产长春瑞滨联合顺铂对中晚期乳腺癌疗效确切,且毒性可以耐受,可以作为对蒽环类药物治疗后复发,中晚期乳腺癌患者的第二线治疗方案.     

Effect of Home-Based Telemonitoring Using Mobile Phone Technology on the Outcome of Heart Failure Patients After an Episode of Acute Decompensation: Randomized Controlled Trial

Background

Telemonitoring of patients with chronic heart failure (CHF) is an emerging concept to detect early warning signs of impending acute decompensation in order to prevent hospitalization.

Objective

The goal of the MOBIle TELemonitoring in Heart Failure Patients Study (MOBITEL) was to evaluate the impact of home-based telemonitoring using Internet and mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation.

Methods

Patients were randomly allocated to pharmacological treatment (control group) or to pharmacological treatment with telemedical surveillance for 6 months (tele group). Patients randomized into the tele group were equipped with mobile phone–based patient terminals for data acquisition and data transmission to the monitoring center. Study physicians had continuous access to the data via a secure Web portal. If transmitted values went outside individually adjustable borders, study physicians were sent an email alert. Primary endpoint was hospitalization for worsening CHF or death from cardiovascular cause.

Results

The study was stopped after randomization of 120 patients (85 male, 35 female); median age was 66 years (IQR 62-72). The control group comprised 54 patients (39 male, 15 female) with a median age of 67 years (IQR 61-72), and the tele group included 54 patients (40 male, 14 female) with a median age of 65 years (IQR 62-72). There was no significant difference between groups with regard to baseline characteristics. Twelve tele group patients were unable to begin data transmission due to the inability of these patients to properly operate the mobile phone (“never beginners”). Four patients did not finish the study due to personal reasons. Intention-to-treat analysis at study end indicated that 18 control group patients (33%) reached the primary endpoint (1 death, 17 hospitalizations), compared with 11 tele group patients (17%, 0 deaths, 11 hospitalizations; relative risk reduction 50%, 95% CI 3-74%, P = .06). Per-protocol analysis revealed that 15% of tele group patients (0 deaths, 8 hospitalizations) reached the primary endpoint (relative risk reduction 54%, 95% CI 7-79%, P= .04). NYHA class improved by one class in tele group patients only (P< .001). Tele group patients who were hospitalized for worsening heart failure during the study had a significantly shorter length of stay (median 6.5 days, IQR 5.5-8.3) compared with control group patients (median 10.0 days, IQR 7.0-13.0; P= .04). The event rate of never beginners was not higher than the event rate of control group patients.

Conclusions

Telemonitoring using mobile phones as patient terminals has the potential to reduce frequency and duration of heart failure hospitalizations. Providing elderly patients with an adequate user interface for daily data acquisition remains a challenging component of such a concept.     

Emotional Approach Coping and the Effects of Online Peer-Led Support Group Participation Among Patients With Breast Cancer: A Longitudinal Study

Background

Previous research on the effects of online peer support on psychological well-being of patients with cancer showed mixed findings. There is a need for longitudinal studies explaining if and when online peer-led support groups are beneficial. How patients cope with emotions that come along with the cancer diagnosis might influence effectiveness of online participation. Emotional approach coping is a construct encompassing the intentional use of emotional processing and emotional expression in efforts to manage adverse circumstances.

Objective

In this longitudinal study, we hypothesize that mixed findings in previous research are partly caused by individual differences in coping with emotions, which may moderate the effects of online support group participation on patients’ well-being.

Methods

A total of 133 Dutch patients with breast cancer filled out a baseline (T0) and a follow-up (T1, 6 months later) questionnaire assessing intensity of online participation within the online support community, emotional approach coping (ie, actively processing and expressing emotions), and psychological well-being (depression, emotional well-being, and breast cancer–related concerns). There were 109 patients who visited an online support community at both points in time. Repeated measures ANOVAs assessed change in well-being over time.

Results

Results showed 3-way interactions of time, online intensity of participation, and emotional approach coping on emotional well-being (F _1,89=4.232, P=.04, η² _ρ=.045) and depression (F _1,88=8.167, P=.005, η² _ρ=.085). Online support group participation increased emotional well-being over time for patients who scored low on emotional approach coping at T0, provided that they were highly active online. Patients who were highly active online with a high score on emotional approach coping reported no change in sense of well-being, but showed the highest score on well-being overall. Participating less frequently online was only beneficial for patients who scored high on emotional approach coping, showing an increase in well-being over time. Patients participating less frequently and with a low score on emotional approach coping reported no significant change in well-being over time.

Conclusions

This study extends previous findings on the effects of online peer support in two ways: by testing changes in well-being as a function of intensity of online support group participation and by examining the role of individual differences in emotional coping styles. Findings showed no negative effects of intense support group participation. Participating frequently online was especially helpful for patients who approach their emotions less actively; their emotional well-being increased over time. In contrast, frequent online users who actively approach their emotions experienced no change in well-being, reporting highest levels of well-being overall. For patients who participate less intensively within the support community, coping style seems to outweigh effects of online participation; over time, patients who actively approached emotions experienced an increase in psychological well-being, whereas patients with a low score on emotional approach coping reported no change in depression and emotional well-being.