Feasibility and Acceptability of a Remotely Delivered, Web-Based Behavioral Intervention for Men With Prostate Cancer: Four-Arm Randomized Controlled Pilot Trial.
cancer
diet
exercise
internet
lifestyle
physical activity
survivorship
text messages
Journal
Journal of medical Internet research
ISSN: 1438-8871
Titre abrégé: J Med Internet Res
Pays: Canada
ID NLM: 100959882
Informations de publication
Date de publication:
31 12 2020
31 12 2020
Historique:
received:
14
04
2020
accepted:
11
11
2020
revised:
07
08
2020
entrez:
31
12
2020
pubmed:
1
1
2021
medline:
16
3
2021
Statut:
epublish
Résumé
Diet and exercise may be associated with quality of life and survival in men with prostate cancer. This study aimed to determine the feasibility and acceptability of a remotely delivered web-based behavioral intervention among men with prostate cancer. 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. 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. 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. ClinicalTrials.gov NCT03406013; http://clinicaltrials.gov/ct2/show/NCT03406013.
Sections du résumé
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.
Identifiants
pubmed: 33382378
pii: v22i12e19238
doi: 10.2196/19238
pmc: PMC7808895
doi:
Banques de données
ClinicalTrials.gov
['NCT03406013']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e19238Subventions
Organisme : NCI NIH HHS
ID : K07 CA197077
Pays : United States
Organisme : NCI NIH HHS
ID : P30 CA069533
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001872
Pays : United States
Organisme : NIDDK NIH HHS
ID : P30 DK098722
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR002369
Pays : United States
Informations de copyright
©June M Chan, Erin L Van Blarigan, Crystal S Langlais, Shoujun Zhao, Justin W Ramsdill, Kimi Daniel, Greta Macaire, Elizabeth Wang, Kellie Paich, Elizabeth R Kessler, Tomasz M Beer, Karen S Lyons, Jeanette M Broering, Peter R Carroll, Stacey A Kenfield, Kerri M Winters-Stone. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 31.12.2020.
Références
JMIR Res Protoc. 2018 Nov 15;7(11):e11257
pubmed: 30442638
Int J Cancer. 2012 Jul 1;131(1):201-10
pubmed: 21823116
J Cancer Surviv. 2016 Aug;10(4):633-44
pubmed: 26715587
Eur Urol. 2017 Dec;72(6):931-939
pubmed: 28711382
Med Sci Sports Exerc. 2001 Jul;33(7):1126-41
pubmed: 11445760
J Cancer Surviv. 2017 Oct;11(5):525-541
pubmed: 28639157
BMC Cancer. 2017 Jun 26;17(1):446
pubmed: 28651586
Pilot Feasibility Stud. 2016 Oct 21;2:64
pubmed: 27965879
Am J Epidemiol. 1992 May 15;135(10):1114-26; discussion 1127-36
pubmed: 1632423
Int J Med Inform. 2019 Aug;128:18-23
pubmed: 31160007
Cancer Manag Res. 2017 Nov 28;9:721-730
pubmed: 29238222
J Clin Oncol. 2012 Jul 1;30(19):2354-61
pubmed: 22614994
J Biomed Inform. 2009 Apr;42(2):377-81
pubmed: 18929686
J Med Internet Res. 2019 Nov 27;21(11):e15787
pubmed: 31774408
Am J Prev Med. 2002 Feb;22(2):120-33
pubmed: 11818183
Arch Phys Med Rehabil. 2015 Jan;96(1):7-14
pubmed: 25194450
Cancer Causes Control. 2006 Mar;17(2):199-208
pubmed: 16425098
CA Cancer J Clin. 2012 Jul-Aug;62(4):243-74
pubmed: 22539238
Cancer Prev Res (Phila). 2015 Jun;8(6):545-51
pubmed: 26031631
Prostate Cancer Prostatic Dis. 2009;12(2):198-203
pubmed: 18852703
Eur Urol. 2016 Oct;70(4):576-585
pubmed: 26774959
Cancer Epidemiol Biomarkers Prev. 2015 Jan;24(1):57-64
pubmed: 25527697
Telemed J E Health. 2009 Nov;15(9):851-8
pubmed: 19919191
World J Urol. 2017 Jun;35(6):867-874
pubmed: 27518576
J Am Geriatr Soc. 2017 Jul;65(7):1414-1419
pubmed: 28263373
Am J Epidemiol. 2019 Mar 1;188(3):579-586
pubmed: 30496346
Br J Nutr. 2019 Sep 14;122(5):592-600
pubmed: 31177994
J Med Internet Res. 2018 Apr 11;20(4):e144
pubmed: 29643048
J Med Imaging Radiat Oncol. 2014 Apr;58(2):223-8
pubmed: 24118850
JMIR Res Protoc. 2018 May 02;7(5):e117
pubmed: 29720358
Contemp Clin Trials. 2017 Jun;57:51-57
pubmed: 28408335
BMC Public Health. 2018 Aug 31;18(1):1082
pubmed: 30170586
J Cancer Surviv. 2018 Aug;12(4):571-591
pubmed: 29770953
J Clin Oncol. 2011 Feb 20;29(6):726-32
pubmed: 21205749
Am J Clin Nutr. 2008 Nov;88(5):1297-303
pubmed: 18996866
CA Cancer J Clin. 2019 Sep;69(5):363-385
pubmed: 31184787
Cancer Prev Res (Phila). 2011 Dec;4(12):2110-21
pubmed: 21930800
Eur J Cancer Care (Engl). 2014 Mar;23(2):263-73
pubmed: 24134506
JMIR Mhealth Uhealth. 2019 Oct 31;7(10):e15018
pubmed: 31674920
J Med Internet Res. 2011 Mar 10;13(1):e30
pubmed: 21393123
J Med Internet Res. 2013 Feb 20;15(2):e37
pubmed: 23425685
Am J Clin Nutr. 2010 Mar;91(3):712-21
pubmed: 20042525
Cancer Causes Control. 2015 Aug;26(8):1117-26
pubmed: 26047644
Med Sci Sports Exerc. 2014 Aug;46(8):1482-8
pubmed: 24500540
JAMA. 2009 May 13;301(18):1883-91
pubmed: 19436015
Int J Behav Nutr Phys Act. 2018 Jun 7;15(1):49
pubmed: 29880049
BMC Cancer. 2018 Nov 6;18(1):1073
pubmed: 30400784
Int J Behav Nutr Phys Act. 2018 Oct 30;15(1):106
pubmed: 30376857
Cancer Treat Rev. 2018 Sep;69:188-203
pubmed: 30077954
Cancer Res. 2011 Jun 1;71(11):3889-95
pubmed: 21610110
Med Clin North Am. 2017 Jul;101(4):787-806
pubmed: 28577627
Contemp Clin Trials. 2018 Mar;66:9-19
pubmed: 29330081
Cancer Epidemiol Biomarkers Prev. 2012 Mar;21(3):428-36
pubmed: 22315365