Surviving and thriving with cancer using a Web-based health behavior change intervention: randomized controlled trial.
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ABSTRACT:
SUBMITTER: Bantum EO
PROVIDER: S-EPMC3961702 | biostudies-literature | 2014 Feb
REPOSITORIES: biostudies-literature
Publications
Surviving and thriving with cancer using a Web-based health behavior change intervention: randomized controlled trial.
Bantum Erin O'Carrol EO Albright Cheryl L CL White Kami K KK Berenberg Jeffrey L JL Layi Gabriela G Ritter Phillip L PL Laurent Diana D Plant Katy K Lorig Kate K
Journal of medical Internet research 20140224 2
<h4>Background</h4>Given the substantial improvements in cancer screening and cancer treatment in the United States, millions of adult cancer survivors live for years following their initial cancer diagnosis and treatment. However, latent side effects can occur and some symptoms can be alleviated or managed effectively via changes in lifestyle behaviors.<h4>Objective</h4>The purpose of this study was to test the effectiveness of a six-week Web-based multiple health behavior change program for ad ...[more]
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Project description:BackgroundTo determine the efficacy of behavior change techniques applied in dietary and physical activity intervention studies, it is first necessary to record and describe techniques that have been used during such interventions. Published frameworks used in dietary and smoking cessation interventions undergo continuous development, and most are not adapted for Web-based delivery. The Food4Me study (N=1607) provided the opportunity to use existing frameworks to describe standardized Web-based techniques employed in a large-scale, internet-based intervention to change dietary behavior and physical activity.ObjectiveThe aims of this study were (1) to describe techniques embedded in the Food4Me study design and explain the selection rationale and (2) to demonstrate the use of behavior change technique taxonomies, develop standard operating procedures for training, and identify strengths and limitations of the Food4Me framework that will inform its use in future studies.MethodsThe 6-month randomized controlled trial took place simultaneously in seven European countries, with participants receiving one of four levels of personalized advice (generalized, intake-based, intake+phenotype-based, and intake+phenotype+gene-based). A three-phase approach was taken: (1) existing taxonomies were reviewed and techniques were identified a priori for possible inclusion in the Food4Me study, (2) a standard operating procedure was developed to maintain consistency in the use of methods and techniques across research centers, and (3) the Food4Me behavior change technique framework was reviewed and updated post intervention. An analysis of excluded techniques was also conducted.ResultsOf 46 techniques identified a priori as being applicable to Food4Me, 17 were embedded in the intervention design; 11 were from a dietary taxonomy, and 6 from a smoking cessation taxonomy. In addition, the four-category smoking cessation framework structure was adopted for clarity of communication. Smoking cessation texts were adapted for dietary use where necessary. A posteriori, a further 9 techniques were included. Examination of excluded items highlighted the distinction between techniques considered appropriate for face-to-face versus internet-based delivery.ConclusionsThe use of existing taxonomies facilitated the description and standardization of techniques used in Food4Me. We recommend that for complex studies of this nature, technique analysis should be conducted a priori to develop standardized procedures and training and reviewed a posteriori to audit the techniques actually adopted. The present framework description makes a valuable contribution to future systematic reviews and meta-analyses that explore technique efficacy and underlying psychological constructs. This was a novel application of the behavior change taxonomies and was the first internet-based personalized nutrition intervention to use such a framework remotely.Trial registrationClinicalTrials.gov NCT01530139; https://clinicaltrials.gov/ct2/show/NCT01530139 (Archived by WebCite at http://www.webcitation.org/6y8XYUft1).
| S-EPMC5913568 | biostudies-literature
Project description:BackgroundAn extraordinary increase in mobile phone ownership has revolutionized the opportunities to use mobile health approaches in lower- and middle-income countries (LMICs). Ecological momentary assessment and intervention (EMAI) uses mobile technology to gather data and deliver timely, personalized behavior change interventions in an individual's natural setting. To our knowledge, there have been no previous trials of EMAI in sub-Saharan Africa.ObjectiveTo advance the evidence base for mobile health (mHealth) interventions in LMICs, we conduct a pilot randomized trial to assess the feasibility of EMAI and establish estimates of the potential effect of EMAI on a range of health-related behaviors in Rakai, Uganda.MethodsThis prospective, parallel-group, randomized pilot trial compared health behaviors between adult participants submitting ecological momentary assessment (EMA) data and receiving behaviorally responsive interventional health messaging (EMAI) with those submitting EMA data alone. Using a fully automated mobile phone app, participants submitted daily reports on 5 different health behaviors (fruit consumption, vegetable consumption, alcohol intake, cigarette smoking, and condomless sex with a non-long-term partner) during a 30-day period before randomization (P1). Participants were then block randomized to the control arm, continuing EMA reporting through exit, or the intervention arm, EMA reporting and behavioral health messaging receipt. Participants exited after 90 days of follow-up, divided into study periods 2 (P2: randomization + 29 days) and 3 (P3: 30 days postrandomization to exit). We used descriptive statistics to assess the feasibility of EMAI through the completeness of data and differences in reported behaviors between periods and study arms.ResultsThe study included 48 participants (24 per arm; 23/48, 48% women; median age 31 years). EMA data collection was feasible, with 85.5% (3777/4418) of the combined days reporting behavioral data. There was a decrease in the mean proportion of days when alcohol was consumed in both arms over time (control: P1, 9.6% of days to P2, 4.3% of days; intervention: P1, 7.2% of days to P3, 2.4% of days). Decreases in sex with a non-long-term partner without a condom were also reported in both arms (P1 to P3 control: 1.9% of days to 1% of days; intervention: 6.6% of days to 1.3% of days). An increase in vegetable consumption was found in the intervention (vegetable: 65.6% of days to 76.6% of days) but not in the control arm. Between arms, there was a significant difference in the change in reported vegetable consumption between P1 and P3 (control: 8% decrease in the mean proportion of days vegetables consumed; intervention: 11.1% increase; P=.01).ConclusionsPreliminary estimates suggest that EMAI may be a promising strategy for promoting behavior change across a range of behaviors. Larger trials examining the effectiveness of EMAI in LMICs are warranted.Trial registrationClinicalTrials.gov NCT04375423; https://www.clinicaltrials.gov/ct2/show/NCT04375423.
| S-EPMC8335611 | biostudies-literature
Project description:BACKGROUND:Web-based interventions with a focus on behavior change have been used for pain management, but studies of Web-based interventions integrated in clinical practice are lacking. To emphasize the development of cognitive skills and behavior, and to increase activity and self-care in rehabilitation, the Web Behavior Change Program for Activity (Web-BCPA) was developed and added to multimodal pain rehabilitation (MMR). OBJECTIVE:The objective of our study was to evaluate the effects of MMR in combination with the Web-BCPA compared with MMR among persons with persistent musculoskeletal pain in primary health care on pain intensity, self-efficacy, and copying, as part of a larger collection of data. Web-BCPA adherence and feasibility, as well as treatment satisfaction, were also investigated. METHODS:A total of 109 participants, mean age 43 (SD 11) years, with persistent pain in the back, neck, shoulder, and/or generalized pain were recruited to a randomized controlled trial with two intervention arms: (1) MMR+WEB (n=60) and (2) MMR (n=49). Participants in the MMR+WEB group self-guided through the eight modules of the Web-BCPA: pain, activity, behavior, stress and thoughts, sleep and negative thoughts, communication and self-esteem, solutions, and maintenance and progress. Data were collected with a questionnaire at baseline and at 4 and 12 months. Outcome measures were pain intensity (Visual Analog Scale), self-efficacy to control pain and to control other symptoms (Arthritis Self-Efficacy Scale), general self-efficacy (General Self-Efficacy Scale), and coping (two-item Coping Strategies Questionnaire; CSQ). Web-BCPA adherence was measured as minutes spent in the program. Satisfaction and Web-BCPA feasibility were assessed by a set of items. RESULTS:Of 109 participants, 99 received the allocated intervention (MMR+WEB: n=55; MMR: n=44); 88 of 99 (82%) completed the baseline and follow-up questionnaires. Intention-to-treat analyses were performed with a sample size of 99. The MMR+WEB intervention was effective over time (time*group) compared to MMR for the two-item CSQ catastrophizing subscale (P=.003), with an effect size of 0.61 (Cohen d) at 12 months. There were no significant between-group differences over time (time*group) regarding pain intensity, self-efficacy (pain, other symptoms, and general), or regarding six subscales of the two-item CSQ. Improvements over time (time) for the whole study group were found regarding mean (P<.001) and maximum (P=.002) pain intensity. The mean time spent in the Web-based program was 304 minutes (range 0-1142). Participants rated the items of Web-BCPA feasibility between 68/100 and 90/100. Participants in the MMR+WEB group were more satisfied with their MMR at 4 months (P<.001) and at 12 months (P=.003). CONCLUSIONS:Adding a self-guided Web-based intervention with a focus on behavioral change for activity to MMR can reduce catastrophizing and increase satisfaction with MMR. Patients in MMR may need more supportive coaching to increase adherence in the Web-BCPA to find it valuable. CLINICALTRIAL:Clinicaltrials.gov NCT01475591; https://clinicaltrials.gov/ct2/show/NCT01475591 (Archived by WebCite at http://www.webcitation.org/6kUnt7VQh).
| S-EPMC5071618 | biostudies-literature
Project description:Social robots are increasingly demonstrating effectiveness as low-intensity behavior change agents. Key targets for these behavioral interventions include daily lifestyle behaviors with significant health consequences, such as the consumption of high-calorie foods and drinks ('snacks'). A pilot randomized controlled trial using a stepped-wedge design was conducted to determine the efficacy of a motivational intervention by an autonomous robot, to help reduce high-calorie snacks. Twenty-six adults were randomized to receive Immediate or 4-week Delayed treatment, with assessments at Baseline and Weeks 4 and 8. The treatment comprised motivation enhancement and self-management training using mental imagery (Functional Imagery Training). A significant condition by time effect for snack episode reduction was obtained, F(2, 32.06) = 4.30, p = .022. The Immediate condition significantly reduced snacking between Baseline and Week 4 (d = -1.06), while the Delayed condition did not (d = -0.08). Immediate participants maintained their improvement between Weeks 4 and 8 (d = -0.18), and Delayed participants then showed a significant fall (d = -1.42). Overall, 'Immediate' participants decreased their snack episodes by 54% and 'Delayed' decreased by 62% from Baseline to Week 8, and an average weight reduction of 4.4 kg was seen across over the first 2 weeks of treatment. Four weeks after starting the intervention, both conditions had significant increases in perceived confidence to control snack intake for time duration, specific scenarios and emotional states (d = 0.61 to 1.42). Working alliance was significantly correlated with reduced snack episodes. The pilot's results appear to suggest that the robot-delivered intervention may be as effective as a human clinician delivering a similar intervention. The robot-delivered pilot achieved similar snack episode reduction in the first four weeks (FIT-R, 55%) when compared with the human-delivered version by a trained clinician (FIT-H, 49%). Overall, the results provide preliminary evidence for an autonomous social robot to deliver a low-intensity treatment on dietary intake without the need for human intervention. Future trials should extend the deployment of the robot-delivered intervention protocol to other low-intensity behavioral outcomes.
| S-EPMC7240221 | biostudies-literature
Project description:BACKGROUND:Rising obesity levels remain a major public health concern due to the clear link with several comorbidities such as diabetes. Diabetes now affects 6% of the UK population. Modest weight loss of 5% to 10% has been shown to be associated with significant reductions in blood sugar, lipid, and blood pressure levels. Men have been shown to be attracted to programs that do not require extensive face-to-face time commitments, illustrating the potential audience available for health behavior change via the Web. OBJECTIVE:The objective of our study was to evaluate the feasibility and acceptability of a Web-based weight loss intervention in men with type 2 diabetes. METHODS:We conducted a pilot, parallel 2-arm, individually randomized controlled trial with embedded process evaluation. Participants were randomly assigned in a one-to-one ratio to the usual care group or the 12-month Web-based weight loss intervention, including dietitian and exercise expert feedback. Face-to-face recruitment and assessment were performed by the researcher unblinded. Data collected included weight, height, body mass index (BMI), and waist circumference, together with an audit trail of eligibility, recruitment, retention, and adherence rates. A process evaluation (website use data and qualitative interviews) monitored adherence, acceptability, and feasibility of the intervention. RESULTS:General practice database searches achieved the recruitment target (n=61) for the population of men with type 2 diabetes, of whom 66% (40/61) completed 3-month follow-up measurements. By 12 months, the retention rate was 52% (32/61), with 12 of the 33 men allocated to the intervention group still active on the website. The intervention was seen as acceptable by the majority of participants. We gained insights about acceptability and use of the website from the parallel process evaluation. CONCLUSIONS:Recruitment to the Web-based weight loss intervention was successful. Results are descriptive, but there were positive indications of increased weight loss (in kilograms and as a percentage), and reduced waist circumference and BMI for the intervention group from 3 to 12 months, in comparison with control. This research adds to the evidence base in relation to incorporating a Web-based weight loss intervention within the UK National Health Service (NHS). NHS weight loss services are struggling to provide sufficient referrals. Therefore, alternative modes of delivery, with the potential to reduce health professional input and time per patient while still enabling individual and tailored care, need to be investigated to identify whether they can be effective and thus benefit the NHS. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number (ISRCTN): 48086713; http://www.isrctn.com/ISRCTN48086713 (Archived by WebCite at http://www.webcitation.org/6rO4xSlhI).
| S-EPMC6238853 | biostudies-other
Project description:Little is known about the effects of physical activity behavior change interventions on health outcomes such as lower extremity dysfunction and SF-36 physical health (predictor of mortality) in breast cancer survivors. Furthermore, effect moderators are rarely reported. Therefore, we report the effects of the 3-month BEAT Cancer physical activity behavior change intervention on global health status and health indicators along with moderators of intervention outcomes. Postprimary treatment breast cancer survivors (n = 222) were randomized to BEAT Cancer or usual care (UC). SF-36, muscle strength, body mass index, lower extremity dysfunction (WOMAC), and life satisfaction were measured at 3 months (M3) and 6 months (M6). At M3, adjusted linear mixed-model analyses demonstrated statistically significant effects of BEAT Cancer versus UC on SF-36 physical health [mean between-group difference (M) = 2.1; 95 % confidence interval (CI) 0.3-3.9; p = 0.023], SF-36 mental health (M = 5.2; CI 2.8-7.6; p < 0.001), and all SF-36 subscores. Intervention benefits occurred for lower extremity physical dysfunction (M = -2.7; CI -5.0 to -0.5; p = 0.018), WOMAC total (M = -3.7; CI -6.7 to -0.6; p = 0.018), and life satisfaction (M = 2.4; CI 0.9-3.9; p = 0.001). Statistically significant effects persisted at M6 for mental health and vitality. Baseline value, income, marital status, cancer treatment, cancer stage, and months since diagnosis moderated one or more outcomes. BEAT Cancer improves SF-36, WOMAC, and life satisfaction outcomes with improvements in vitality and mental well-being continuing 3 months postintervention. Several moderators with potential to guide targeting individuals for optimal intervention benefit warrant further study.
| S-EPMC5014640 | biostudies-literature
Project description:BACKGROUND:Psychological interventions for the prevention of depression might be a cost-effective way to reduce the burden associated with depressive disorders. OBJECTIVE:To evaluate the cost-effectiveness of a Web-based guided self-help intervention to prevent major depressive disorder (MDD) in people with subthreshold depression (sD). METHODS:A pragmatic randomized controlled trial was conducted with follow-up at 12 months. Participants were recruited from the general population via a large statutory health insurance company and an open access website. Participants were randomized to a Web-based guided self-help intervention (ie, cognitive-behavioral therapy and problem-solving therapy assisted by supervised graduate students or health care professionals) in addition to usual care or to usual care supplemented with Web-based psycho-education (enhanced usual care). Depression-free years (DFYs) were assessed by blinded diagnostic raters using the telephone-administered Structured Clinical Interview for DSM-IV Axis Disorders at 6- and 12-month follow-up, covering the period to the previous assessment. Costs were self-assessed through a questionnaire. Costs measured from a societal and health care perspective were related to DFYs and quality-adjusted life years (QALYs). RESULTS:In total, 406 participants were enrolled in the trial. The mean treatment duration was 5.84 (SD 4.37) weeks. On average, participants completed 4.93 of 6 sessions. Significantly more DFYs were gained in the intervention group (0.82 vs 0.70). Likewise, QALY health gains were in favor of the intervention, but only statistically significant when measured with the more sensitive SF-6D. The incremental per-participant costs were €136 (£116). Taking the health care perspective and assuming a willingness-to-pay of €20,000 (£17,000), the intervention's likelihood of being cost-effective was 99% for gaining a DFY and 64% or 99% for gaining an EQ-5D or a SF-6D QALY. CONCLUSIONS:Our study supports guidelines recommending Web-based treatment for sD and adds that this not only restores health in people with sD, but additionally reduces the risk of developing a MDD. Offering the intervention has an acceptable likelihood of being more cost-effective than enhanced usual care and could therefore reach community members on a wider scale. TRIAL REGISTRATION:German Clinical Trials Register: DRKS00004709; http://www.drks.de/DRKS00004709 (Archived by WebCite at http://www.webcitation.org/6kAZVUxy9).
| S-EPMC5244034 | biostudies-other
Project description:Continued smoking after a cancer diagnosis contributes to several negative health outcomes. Although many cancer patients attempt to quit smoking, high smoking relapse rates have been observed. This highlights the need for a targeted, evidence-based smoking-relapse prevention intervention. The design, method, and baseline characteristics of a randomized controlled trial assessing the efficacy of a self-help smoking-relapse prevention intervention are presented. Cancer patients who had recently quit smoking were randomized to one of two conditions. The Usual Care (UC) group received the institution's standard of care. The smoking relapse-prevention intervention (SRP) group received standard of care, plus 8 relapse-prevention booklets mailed over a 3month period, and a targeted educational DVD developed specifically for cancer patients. Four hundred and fourteen participants were enrolled and completed a baseline survey. Primary outcomes will be self-reported smoking status at 6 and 12-months after baseline. Biochemical verification of smoking status was completed for a subsample. If found to be efficacious, this low-cost intervention could be easily disseminated with significant potential for reducing the risk of negative cancer outcomes associated with continued smoking.
| S-EPMC5564185 | biostudies-other
Project description:BackgroundAlthough most adolescents have access to smartphones, few of them use mobile health (mHealth) apps for health improvement, highlighting the apparent lack of interest in mHealth apps among adolescents. Adolescent mHealth interventions have been burdened with high attrition rates. Research on these interventions among adolescents has frequently lacked detailed time-related attrition data alongside analysis of attrition reasons through usage.ObjectiveThe objective was to obtain daily attrition rates among adolescents in an mHealth intervention to gain a deeper understanding of attrition patterns, including the role of motivational support, such as altruistic rewards, through analysis of app usage data.MethodsA randomized controlled trial was conducted with 304 adolescent participants (152 boys and 152 girls) aged 13-15 years. Based on 3 participating schools, participants were randomly assigned to control, treatment as usual (TAU), and intervention groups. Measures were obtained at baseline, continuously throughout the 42-day trial period (research groups), and at the trial end. The mHealth app is called SidekickHealth and is a social health game with the following 3 main categories: nutrition, mental health, and physical health. Primary measures were attrition based on time from launch, and the type, frequency, and time of health behavior exercise usage. Outcome differences were obtained through comparison tests, while regression models and survival analyses were used for attrition measures.ResultsAttrition differed significantly between the intervention and TAU groups (44.4% vs 94.3%; χ21=61.220; P<.001). The mean usage duration was 6.286 days in the TAU group and 24.975 days in the intervention group. In the intervention group, male participants were active significantly longer than female participants (29.155 vs 20.433 days; χ21=6.574; P<.001). Participants in the intervention group completed a larger number of health exercises in all trial weeks, and a significant decrease in usage was observed from the first to second week in the TAU group (t105=9.208; P<.001) but not in the intervention group. There was a significant increase in health exercises in the intervention group from the fifth to sixth week (t105=3.446; P<.001). Such a significant increase in usage was not evident in the TAU group. The research group was significantly related to attrition time (hazard ratio 0.308, 95% CI 0.222-0.420), as well as the numbers of mental health exercises (P<.001) and nutrition exercises (P<.001).ConclusionsDifferences in attrition rates and usage between groups of adolescents were identified. Motivational support is a significant factor for lowering attrition in adolescent mHealth interventions. The results point to sensitivity periods in the completion of diverse health tasks, and emphasis on time-specific attrition, along with the type, frequency, and time of health behavior exercise usage, is likely a fruitful avenue for further research on mHealth interventions for adolescent populations, in which attrition rates remain excessive.Trial registrationClinicalTrials.gov NCT05912439; https://clinicaltrials.gov/study/NCT05912439.
| S-EPMC10337294 | biostudies-literature
Project description:BackgroundImproving the health self-management level of patients with tuberculosis (TB) is significant for reducing drug resistance, improving the cure rate, and controlling the prevalence of TB. Mobile health (mHealth) interventions based on behavioral science theories may be promising to achieve this goal.ObjectiveThis study aims to explore and conduct an mHealth intervention based on the Integrated Theory of Health Behavior Change (ITHBC) in patients with pulmonary TB to increase their ability of self-care management.MethodsA prospective randomized controlled study was conducted from May to November 2020. A total of 114 patients who were admitted consecutively to the TB clinic of Harbin Chest Hospital, China from May 2020 to August 2020 were recruited by convenience sampling. Patients were divided into the control group and intervention group, and all received a 3-month intervention. Patients in the intervention group and the control group received routine medical and nursing care in the TB clinic, including the supervision of their medications. In addition, pharmacist-assisted mHealth (WeChat) intervention based on the ITHBC theory about TB management was provided to the intervention group. The primary outcome was self-management behavior, while the secondary outcomes were TB awareness, self-efficacy, social support, and degree of satisfaction with health education. The outcomes were measured using web-based self-designed and standard questionnaires administered at baseline and at the end point of the study. Intergroup data were assessed using the Mann-Whitney U test, whereas intragroup data were assessed with the Wilcoxon test (for paired samples).ResultsA total of 112 patients (59 in intervention group and 53 in control group) completed the study. After the intervention, a statistically significant increase was noted in the scores of each item of self-care management behaviors compared with the scores at the baseline (P<.001) in the intervention group. The scores of all self-care management behaviors of the control group were lower than those of all self-care management behaviors in the intervention group (all P<.05), except for the item "cover your mouth and nose when coughing or sneezing" (P=.23) and item "wash hands properly" (P=.60), which had no statistically significant difference from those in the intervention group. Compared with those at baseline, TB knowledge awareness, self-efficacy, social support, and degree of satisfaction with health education in the intervention group increased significantly (P<.001), and the intervention group had significantly higher scores than the control group (P<.001).ConclusionsmHealth intervention for TB self-management based on ITHBC could deepen the understanding of patients with TB about their disease and improve their objective initiative and self-care management behaviors, which were beneficial for promoting compliance behavior and quality of prevention and control for pulmonary TB.Trial registrationChinese Clinical Trial Registry ChiCTR2200055557; https://tinyurl.com/4ray3xnw.
| S-EPMC9335179 | biostudies-literature