scholarly journals Feasibility and Acceptability of a Remotely Delivered, Web-Based Behavioral Intervention for Men With Prostate Cancer: Four-Arm Randomized Controlled Pilot Trial (Preprint)

2020 ◽  
Author(s):  
June M Chan ◽  
Erin L Van Blarigan ◽  
Crystal S Langlais ◽  
Shoujun Zhao ◽  
Justin W Ramsdill ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Behavioral Intervention ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Text Messages ◽  
Web Based ◽  
Randomized Controlled ◽  
Phone Calls ◽  
Diet And Exercise ◽  
Level 1

BACKGROUND Diet and exercise may be associated with quality of life and survival in men with prostate cancer. OBJECTIVE This study aimed to determine the feasibility and acceptability of a remotely delivered web-based behavioral intervention among men with prostate cancer. METHODS We conducted a multi-site 4-arm pilot randomized controlled trial of a 3-month intervention (TrueNTH Community of Wellness). Eligibility included self-reported prostate cancer diagnosis, having a personal device that connected to the internet, age ≥18 years, and ability to read English and receive text messages and emails. Men receiving chemotherapy or radiation, or those who reported contraindications to exercise, could participate with physician clearance. Participants were randomized (1:1:1:1) to additive intervention levels: website; website and personalized diet and exercise prescription; website, personalized prescription, Fitbit, and text messages; and website, personalized prescription, Fitbit, text messages, and 2 30-minute phone calls—one with an exercise trainer and one with a registered dietician. Primary outcomes were feasibility (accrual and attrition) and acceptability (survey data and website use). We described self-reported diet and exercise behavior at the time of enrollment, 3 months, and 6 months as secondary outcomes. RESULTS In total, 202 men consented and were randomized between August 2017 and September 2018 (level 1: 49, level 2: 51, level 3: 50, level 4: 52). A total of 160 men completed the onboarding process and were exposed to their randomly assigned intervention (38, 38, 42, and 42 in levels 1, 2, 3, and 4, respectively). The follow-up rate was 82.7% (167/202) at 3 months and 77.2% (156/202) at 6 months. Participants had a median age of 70 years and were primarily White and college educated. Website visit frequency over the 3-month intervention period increased across levels (median: 2, 9, 11, and 16 visits for levels 1, 2, 3, and 4, respectively). Most were satisfied or very satisfied with the intervention (20/39, 51%; 27/42, 64%; 23/44, 52%; and 27/42, 64% for levels 1, 2, 3, and 4, respectively). The percentage of men who reported being very satisfied was highest among level 4 participants (10/42, 24% vs 4/39, 10%; 5/42, 12%; and 5/44, 11% for levels 1, 2, and 3, respectively). Dissatisfaction was highest in level 1 (5/39, 13% vs 1/42, 2%; 3/44, 7%; and 2/42, 5% for levels 2, 3, and 4, respectively). We observed small improvements in diet and physical activity at 3 months among men in level 4 versus those in level 1. CONCLUSIONS A web-based, remotely delivered, tailored behavioral intervention for men with prostate cancer is feasible. Future studies are warranted to increase the effect of the intervention on patient behavior while maintaining sustainability and scalability as well as to design and implement interventions for more diverse populations. CLINICALTRIAL ClinicalTrials.gov NCT03406013; http://clinicaltrials.gov/ct2/show/NCT03406013

scholarly journals Feasibility and Acceptability of a Remotely Delivered, Web-Based Behavioral Intervention for Men With Prostate Cancer: Four-Arm Randomized Controlled Pilot Trial

10.2196/19238 ◽  
2020 ◽  
Vol 22 (12) ◽  
pp. e19238
Author(s):  
June M Chan ◽  
Erin L Van Blarigan ◽  
Crystal S Langlais ◽  
Shoujun Zhao ◽  
Justin W Ramsdill ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Behavioral Intervention ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Text Messages ◽  
Web Based ◽  
Randomized Controlled ◽  
Phone Calls ◽  
Diet And Exercise ◽  
Level 1

Background Diet and exercise may be associated with quality of life and survival in men with prostate cancer. Objective This study aimed to determine the feasibility and acceptability of a remotely delivered web-based behavioral intervention among men with prostate cancer. Methods We conducted a multi-site 4-arm pilot randomized controlled trial of a 3-month intervention (TrueNTH Community of Wellness). Eligibility included self-reported prostate cancer diagnosis, having a personal device that connected to the internet, age ≥18 years, and ability to read English and receive text messages and emails. Men receiving chemotherapy or radiation, or those who reported contraindications to exercise, could participate with physician clearance. Participants were randomized (1:1:1:1) to additive intervention levels: website; website and personalized diet and exercise prescription; website, personalized prescription, Fitbit, and text messages; and website, personalized prescription, Fitbit, text messages, and 2 30-minute phone calls—one with an exercise trainer and one with a registered dietician. Primary outcomes were feasibility (accrual and attrition) and acceptability (survey data and website use). We described self-reported diet and exercise behavior at the time of enrollment, 3 months, and 6 months as secondary outcomes. Results In total, 202 men consented and were randomized between August 2017 and September 2018 (level 1: 49, level 2: 51, level 3: 50, level 4: 52). A total of 160 men completed the onboarding process and were exposed to their randomly assigned intervention (38, 38, 42, and 42 in levels 1, 2, 3, and 4, respectively). The follow-up rate was 82.7% (167/202) at 3 months and 77.2% (156/202) at 6 months. Participants had a median age of 70 years and were primarily White and college educated. Website visit frequency over the 3-month intervention period increased across levels (median: 2, 9, 11, and 16 visits for levels 1, 2, 3, and 4, respectively). Most were satisfied or very satisfied with the intervention (20/39, 51%; 27/42, 64%; 23/44, 52%; and 27/42, 64% for levels 1, 2, 3, and 4, respectively). The percentage of men who reported being very satisfied was highest among level 4 participants (10/42, 24% vs 4/39, 10%; 5/42, 12%; and 5/44, 11% for levels 1, 2, and 3, respectively). Dissatisfaction was highest in level 1 (5/39, 13% vs 1/42, 2%; 3/44, 7%; and 2/42, 5% for levels 2, 3, and 4, respectively). We observed small improvements in diet and physical activity at 3 months among men in level 4 versus those in level 1. Conclusions A web-based, remotely delivered, tailored behavioral intervention for men with prostate cancer is feasible. Future studies are warranted to increase the effect of the intervention on patient behavior while maintaining sustainability and scalability as well as to design and implement interventions for more diverse populations. Trial Registration ClinicalTrials.gov NCT03406013; http://clinicaltrials.gov/ct2/show/NCT03406013

scholarly journals Effect of Increasing Levels of Web-Based Behavioral Support on Changes in Physical Activity, Diet, and Symptoms in Men With Prostate Cancer: Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Kerri M Winters-Stone ◽  
Stacey A Kenfield ◽  
Erin L Van Blarigan ◽  
Esther L Moe ◽  
Justin W Ramsdill ◽  
...  
Keyword(s):  
Physical Activity ◽  
Prostate Cancer ◽  
Dietary Habits ◽  
Controlled Trial ◽  
Behavioral Support ◽  
Web Based ◽  
Prostate Cancer Survivors ◽  
Randomized Controlled ◽  
Level 1

BACKGROUND More than 3.1 million men in the United States are prostate cancer survivors. These men may improve their physical function, quality of life, and potentially their prognosis by adopting healthier lifestyle habits. The internet provides a scalable mechanism to deliver advice and support about improving physical activity and dietary habits, but the feasibility and acceptability of a Web-based lifestyle intervention and the dose of support necessary to improve health behaviors are not yet known. OBJECTIVES The Community of Wellness is a Web-based intervention focused on supporting exercise and healthy dietary practices for men with prostate cancer. The objectives of this study were to determine the feasibility, acceptability, and preliminary efficacy of the Community of Wellness Web portal among prostate cancer survivors by conducting a randomized controlled trial (RCT) comparing 4 levels of additive Web-based content and interaction with participants: Level 1 (Teaching; Control), Level 2 (Teaching + Tailoring), Level 3 (Teaching + Tailoring + Technology), and Level 4 (Teaching + Tailoring + Technology + Touch). METHODS This is a single-blinded RCT comparing 3 levels of behavioral support within the Community of Wellness Web portal intervention (Levels 2 to 4) with each other and with the control condition (Level 1). The control condition receives general static Web-based educational information only on physical activity and dietary habits, self-efficacy for behavior change, motivation for physical activity, and changes in anxiety and treatment-related side effects. We will enroll and randomize 200 men with prostate cancer equally to 4 levels of the Community of Wellness Web-based intervention for 3 months (50 men per level). Surveys will be completed by self-report at baseline, 3 months (immediately postintervention), and 6 months (3 months postintervention). Feasibility and acceptability will be assessed by enrollment statistics, Web-based usage metrics, and surveys at the 3-month time point. We will also conduct focus groups after the postintervention follow-up assessment in a sample of enrolled participants to evaluate elements of usability and acceptability that cannot be obtained via surveys. RESULTS Enrollment is ongoing, with 124 enrolled. Study completion (6-month follow-up) is expected by July 2019. CONCLUSIONS The goal of the study is to identify the level of support that is feasible, acceptable, promotes behavior change, and improves health in men with prostate cancer to inform future efforts to scale the program for broader reach. CLINICALTRIAL ClinicalTrials.gov NCT03406013; https://clinicaltrials.gov/ct2/show/NCT03406013 (Archived by WebCite at http://www.webcitation.org/73YpDIoTX). INTERNATIONAL REGISTERED REPOR PRR1-10.2196/11257

Improved Cancer Coping from a Web‐based Intervention for Prostate Cancer Survivors: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Erin K. Tagai ◽  
Suzanne M. Miller ◽  
Shawna V. Hudson ◽  
Michael A. Diefenbach ◽  
Elizabeth Handorf ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Randomized Controlled Trial ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Web Based ◽  
Prostate Cancer Survivors ◽  
Randomized Controlled ◽  
Cancer Coping

scholarly journals Be Healthe for Your Heart: A Pilot Randomized Controlled Trial Evaluating a Web-Based Behavioral Intervention to Improve the Cardiovascular Health of Women with a History of Preeclampsia

2020 ◽  
Vol 17 (16) ◽  
pp. 5779
Author(s):  
Melinda J. Hutchesson ◽  
Rachael Taylor ◽  
Vanessa A. Shrewsbury ◽  
Lisa Vincze ◽  
Linda E. Campbell ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Health Behaviors ◽  
Behavioral Intervention ◽  
Controlled Trial ◽  
Risk Markers ◽  
Cvd Risk ◽  
Web Based ◽  
Randomized Controlled ◽  
History Of ◽  
Pilot Randomized Controlled Trial

This pilot randomized controlled trial (RCT) aimed to determine the acceptability and preliminary efficacy of a web-based cardiovascular disease (CVD) prevention intervention for women following preeclampsia. Australian women with a recent history (≤4 years post diagnosis) of preeclampsia were randomized into two study arms: (1) Be Healthe for your Heart, a web-based behavioral intervention or; (2) Control, access to the National Heart Foundation website. Assessments were conducted at baseline, and after three months. Intervention acceptability and impact on absolute CVD 30-year risk score, CVD risk markers and health behaviors were assessed. Twenty-four of 31 (77.4%) women completed the three-month assessment. Eleven out of 13 intervention participants (84.6%) agreed/strongly agreed they were satisfied with the program, with a mean score of 4.2 ± 0.9 (maximum of five). There were no significant between or within group differences in absolute CVD risk, CVD risk markers or health behaviors from baseline to three months. Women with a history of preeclampsia were successfully recruited and retained and they reported high levels of acceptability with the Be Healthe for your Heart program. Further research is therefore needed from powered trials to determine the impact of web-based lifestyle interventions on CVD risk in this at-risk group.

scholarly journals Randomized Controlled Trial of Advance Notification Phone Calls vs Text Messages Prior to Mailed Fecal Test Outreach

2020 ◽  
Author(s):  
Gloria D. Coronado ◽  
Denis B. Nyongesa ◽  
Amanda F. Petrik ◽  
Jamie H. Thompson ◽  
Anne L. Escaron ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Text Messages ◽  
Randomized Controlled ◽  
Phone Calls

scholarly journals Effectiveness of a Multistrategy Behavioral Intervention to Increase the Nutritional Quality of Primary School Students’ Web-Based Canteen Lunch Orders (Click & Crunch): Cluster Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Rebecca Wyse ◽  
Tessa Delaney ◽  
Fiona Stacey ◽  
Rachel Zoetemeyer ◽  
Christophe Lecathelinais ◽  
...  
Keyword(s):  
Behavioral Intervention ◽  
Controlled Trial ◽  
Saturated Fat ◽  
Sodium Content ◽  
Choice Architecture ◽  
Web Based ◽  
Randomized Controlled ◽  
School Canteen ◽  
Trial Outcomes ◽  
Cluster Randomized

BACKGROUND School food outlets represent a key setting for public health nutrition intervention. The recent proliferation of web-based food ordering systems provides a unique opportunity to support healthy purchasing from schools. Embedding evidence-based choice architecture strategies within these routinely used systems provides the opportunity to impact the purchasing decisions of many users simultaneously and warrants investigation. OBJECTIVE This study aims to assess the effectiveness of a multistrategy behavioral intervention implemented via a web-based school canteen lunch ordering system in reducing the energy, saturated fat, sugar, and sodium content of primary students’ web-based lunch orders. METHODS The study used a parallel-group, cohort, cluster randomized controlled trial design with 2207 students from 17 Australian primary schools. Schools with a web-based canteen lunch ordering system were randomly assigned to receive either a multistrategy behavioral intervention that included choice architecture strategies embedded in the web-based system (n=9 schools) or the standard web-based ordering system only (n=8 control schools). Automatically collected student purchasing data at baseline (term 2, 2018) and 12 months later (term 2, 2019) were used to assess trial outcomes. Primary trial outcomes included the mean energy (kJ), saturated fat (g), sugar (g), and sodium (mg) content of student lunch orders. Secondary outcomes included the proportion of all web-based lunch order items classified as <i>everyday</i>, <i>occasional</i>, and <i>caution</i> (based on the New South Wales Healthy School Canteen Strategy) and canteen revenue. RESULTS From baseline to follow-up, the intervention lunch orders had significantly lower energy content (−69.4 kJ, 95% CI −119.6 to −19.1; <i>P</i>=.01) and saturated fat content (−0.6 g, 95% CI −0.9 to −0.4; <i>P</i>&lt;.001) than the control lunch orders, but they did not have significantly lower sugar or sodium content. There was also a small significant between-group difference in the percentage of energy from saturated fat (−0.9%, 95% CI −1.4% to −0.5%; <i>P</i>&lt;.001) but not in the percentage of energy from sugar (+1.1%, 95% CI 0.2% to 1.9%; <i>P</i>=.02). Relative to control schools, intervention schools had significantly greater odds of having <i>everyday</i> items purchased (odds ratio [OR] 1.7, 95% CI 1.5-2.0; <i>P</i>&lt;.001), corresponding to a 9.8% increase in <i>everyday</i> items, and lower odds of having <i>occasional</i> items purchased (OR 0.7, 95% CI 0.6-0.8; <i>P</i>&lt;.001), corresponding to a 7.7% decrease in <i>occasional</i> items); however, there was no change in the odds of having <i>caution</i> (least healthy) items purchased (OR 0.8, 95% CI 0.7-1.0; <i>P</i>=.05). Furthermore, there was no change in schools’ revenue between groups. CONCLUSIONS Given the evidence of small statistically significant improvements in the energy and saturated fat content, acceptability, and wide reach, this intervention has the potential to influence dietary choices at a population level, and further research is warranted to determine its impact when implemented at scale. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000855224; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375075. INTERNATIONAL REGISTERED REPORT RR2-10.1136/bmjopen-2019-030538

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