Enhancing Self-care Among Oral Cancer Survivors: Protocol for the Empowered Survivor Trial.
cancer survivorship
digital interventions
oral cancer
quality of life
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
20 Jan 2023
20 Jan 2023
Historique:
received:
31
05
2022
accepted:
14
12
2022
revised:
13
12
2022
entrez:
20
1
2023
pubmed:
21
1
2023
medline:
21
1
2023
Statut:
epublish
Résumé
Survivors of oral cavity and oropharyngeal cancer frequently experience difficulties in swallowing; tasting; speaking; chewing; and maintaining comfortable movements of the head, neck, and shoulder. Engagement in regular self-care can reduce further loss of function and mitigate late effects. Despite the substantial self-care requirements, there are no empirically based interventions to enhance the skills and confidence of these survivors in managing their ongoing care. The aim of this study is to describe the rationale and methodology for a randomized controlled trial evaluating Empowered Survivor (ES) versus Springboard Beyond Cancer, a general web-based program for cancer survivors, on self-efficacy in managing care, preparedness for managing survivorship, and health-related quality of life (QOL). This study will recruit a total of 600 individuals who were diagnosed with oral cavity or oropharyngeal cancer in the past 3 years and are currently cancer free primarily from state cancer registries; these individuals will be randomly assigned to either the ES or Springboard Beyond Cancer condition. The participants complete measures of self-efficacy in managing care, preparedness for survivorship, health-related QOL, and engagement in oral self-examination and head and neck strengthening and flexibility exercises at baseline and 2 and 6 months after baseline. The primary aim of this study is to evaluate the impact of ES versus Springboard Beyond Cancer on self-efficacy, preparedness, and health-related QOL. The secondary aim is to examine the mediators and moderators of ES's impact on self-efficacy in managing care, preparedness, and health-related QOL at 6 months. The exploratory aim is to conduct a process evaluation of ES to identify potential oncology or community settings for future implementation. Multilevel modeling will be used to examine whether there are significant differences between the ES and Springboard Beyond Cancer interventions over time. Mediational models will evaluate the indirect effects of ES on outcomes. Quantitative analyses will evaluate the predictors of ES use, and qualitative analyses will evaluate the preferred timing and settings for the implementation of ES. This randomized controlled trial evaluates a completely web-based intervention, ES, versus a general web-based program for cancer survivors, Springboard Beyond Cancer, on self-efficacy in managing care, preparedness for managing survivorship, and health-related QOL and identifies the putative mediators and moderators of the intervention's effects. If an effect on the primary outcomes is illustrated, the next step could be an implementation trial to evaluate the intervention's uptake in and impact on an oncology care setting or nonprofit organizations. ClincalTrials.gov NCT04713449; https://clinicaltrials.gov/ct2/show/NCT04713449. DERR1-10.2196/39996.
Sections du résumé
BACKGROUND
BACKGROUND
Survivors of oral cavity and oropharyngeal cancer frequently experience difficulties in swallowing; tasting; speaking; chewing; and maintaining comfortable movements of the head, neck, and shoulder. Engagement in regular self-care can reduce further loss of function and mitigate late effects. Despite the substantial self-care requirements, there are no empirically based interventions to enhance the skills and confidence of these survivors in managing their ongoing care.
OBJECTIVE
OBJECTIVE
The aim of this study is to describe the rationale and methodology for a randomized controlled trial evaluating Empowered Survivor (ES) versus Springboard Beyond Cancer, a general web-based program for cancer survivors, on self-efficacy in managing care, preparedness for managing survivorship, and health-related quality of life (QOL).
METHODS
METHODS
This study will recruit a total of 600 individuals who were diagnosed with oral cavity or oropharyngeal cancer in the past 3 years and are currently cancer free primarily from state cancer registries; these individuals will be randomly assigned to either the ES or Springboard Beyond Cancer condition. The participants complete measures of self-efficacy in managing care, preparedness for survivorship, health-related QOL, and engagement in oral self-examination and head and neck strengthening and flexibility exercises at baseline and 2 and 6 months after baseline. The primary aim of this study is to evaluate the impact of ES versus Springboard Beyond Cancer on self-efficacy, preparedness, and health-related QOL. The secondary aim is to examine the mediators and moderators of ES's impact on self-efficacy in managing care, preparedness, and health-related QOL at 6 months. The exploratory aim is to conduct a process evaluation of ES to identify potential oncology or community settings for future implementation.
RESULTS
RESULTS
Multilevel modeling will be used to examine whether there are significant differences between the ES and Springboard Beyond Cancer interventions over time. Mediational models will evaluate the indirect effects of ES on outcomes. Quantitative analyses will evaluate the predictors of ES use, and qualitative analyses will evaluate the preferred timing and settings for the implementation of ES.
CONCLUSIONS
CONCLUSIONS
This randomized controlled trial evaluates a completely web-based intervention, ES, versus a general web-based program for cancer survivors, Springboard Beyond Cancer, on self-efficacy in managing care, preparedness for managing survivorship, and health-related QOL and identifies the putative mediators and moderators of the intervention's effects. If an effect on the primary outcomes is illustrated, the next step could be an implementation trial to evaluate the intervention's uptake in and impact on an oncology care setting or nonprofit organizations.
TRIAL REGISTRATION
BACKGROUND
ClincalTrials.gov NCT04713449; https://clinicaltrials.gov/ct2/show/NCT04713449.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
DERR1-10.2196/39996.
Identifiants
pubmed: 36662561
pii: v12i1e39996
doi: 10.2196/39996
pmc: PMC9898837
doi:
Banques de données
ClinicalTrials.gov
['NCT04713449']
Types de publication
Journal Article
Langues
eng
Pagination
e39996Subventions
Organisme : NCI NIH HHS
ID : R01 CA240344
Pays : United States
Informations de copyright
©Sharon L Manne, Matin Imanguli, Deborah Kashy, Morgan Pesanelli, Sara Frederick, Janet H Van Cleave, Lisa Paddock, Shawna Hudson, Michael Steinberg, Patrick Clifford, Mara Domider, Neetu Singh. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 20.01.2023.
Références
J Clin Oncol. 2011 Nov 10;29(32):4294-301
pubmed: 21969503
BMC Cancer. 2016 Jan 05;16:4
pubmed: 26732757
Med Oral Patol Oral Cir Bucal. 2013 Jul 01;18(4):e578-84
pubmed: 23722141
J Gen Intern Med. 2001 Sep;16(9):606-13
pubmed: 11556941
Transl Behav Med. 2020 May 20;10(2):355-363
pubmed: 30608607
J Consult Clin Psychol. 2013 Apr;81(2):318-35
pubmed: 22663900
Oral Oncol. 2009 Nov;45(11):946-52
pubmed: 19631574
Br J Cancer. 2001 Jan;84(2):149-56
pubmed: 11161369
Eur J Oncol Nurs. 2011 Apr;15(2):145-51
pubmed: 20864401
Contemp Clin Trials. 2016 Mar;47:64-71
pubmed: 26706665
Behav Res Methods. 2008 Aug;40(3):879-91
pubmed: 18697684
Psychosom Med. 2011 May;73(4):323-35
pubmed: 21536837
Head Neck. 2011 Apr;33(4):458-68
pubmed: 20652979
J Oncol. 2012;2012:649498
pubmed: 22577381
J Pain Symptom Manage. 2009 Jan;37(1):94-106
pubmed: 19111778
Br J Oral Maxillofac Surg. 2006 Jun;44(3):187-92
pubmed: 16095776
BMC Cancer. 2017 Oct 30;17(1):706
pubmed: 29084516
Psychol Sci. 2007 Mar;18(3):233-9
pubmed: 17444920
Int J Oral Maxillofac Surg. 2002 Aug;31(4):427-33
pubmed: 12361079
Br J Soc Psychol. 2006 Mar;45(Pt 1):87-106
pubmed: 16573874
Health Promot Pract. 2018 Jan;19(1):134-144
pubmed: 28627254
Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26
pubmed: 15230939
Eur J Cancer Care (Engl). 2020 Jul;29(4):e13243
pubmed: 32510671
Br J Cancer. 1995 Feb;71(2):397-9
pubmed: 7841060
Med Decis Making. 2014 May;34(4):454-63
pubmed: 24246567
Oral Oncol. 2018 Sep;84:88-94
pubmed: 30115482
Psychooncology. 2013 Jun;22(6):1220-8
pubmed: 22730021
Med Care. 2006 Nov;44(11):964-71
pubmed: 17063127
Support Care Cancer. 2012 Aug;20(8):1811-4
pubmed: 21947441
Am J Clin Oncol. 2005 Feb;28(1):17-20
pubmed: 15685029
Auris Nasus Larynx. 2015 Oct;42(5):401-5
pubmed: 25998850
BMC Psychiatry. 2016 Feb 02;16:22
pubmed: 26831145
J Appl Oral Sci. 2010 May-Jun;18(3):279-84
pubmed: 20857008
Br J Oral Maxillofac Surg. 2006 Oct;44(5):371-6
pubmed: 16624459
Trials. 2013 Apr 30;14:116
pubmed: 23782890
MMWR Morb Mortal Wkly Rep. 2020 Apr 17;69(15):433-438
pubmed: 32298244
Prev Med. 2005 Jun;40(6):769-78
pubmed: 15850878
Head Neck. 2016 Apr;38 Suppl 1:E1935-46
pubmed: 26788714
J Am Dent Assoc. 2006 Feb;137(2):203-12
pubmed: 16521387
Ann Behav Med. 2003 Winter;25(1):16-24
pubmed: 12581932
Oral Oncol. 2016 May;56:1-7
pubmed: 27086480
J Consult Clin Psychol. 2007 Aug;75(4):615-628
pubmed: 17663615
Arch Pathol Lab Med. 2018 May;142(5):559-597
pubmed: 29251996
Health Psychol. 2000 Sep;19(5):487-95
pubmed: 11007157
J Cancer Res Clin Oncol. 2016 Feb;142(2):521-8
pubmed: 26507889
Eur Arch Otorhinolaryngol. 2017 Feb;274(2):597-606
pubmed: 27086361
J Clin Oncol. 2008 Feb 1;26(4):612-9
pubmed: 18235120
J Oral Maxillofac Surg. 2002 Jul;60(7):772-7
pubmed: 12089691
J Med Internet Res. 2011 Feb 14;13(1):e17
pubmed: 21320854
J Health Psychol. 2011 Jul;16(5):728-38
pubmed: 21441356
J Med Internet Res. 2016 Jan 08;18(1):e6
pubmed: 26747176
Community Dent Oral Epidemiol. 2007 Jun;35(3):233-40
pubmed: 17518970
Prev Sci. 2018 Apr;19(3):284-294
pubmed: 27040106
J Chronic Dis. 1987;40(5):373-83
pubmed: 3558716
Behav Res Methods Instrum Comput. 2004 Nov;36(4):717-31
pubmed: 15641418
Rehabil Res Pract. 2013;2013:601768
pubmed: 24455274
Cancer Nurs. 2020 Jan/Feb;43(1):12-21
pubmed: 30433894
J Eval Clin Pract. 2009 Aug;15(4):602-6
pubmed: 19522727
Patient Educ Couns. 2002 Oct -Nov;48(2):177-87
pubmed: 12401421
Psychooncology. 2019 Apr;28(4):742-749
pubmed: 30695104
Oral Oncol. 2011 Oct;47(10):967-73
pubmed: 21827968
Otolaryngol Clin North Am. 2012 Aug;45(4):863-78
pubmed: 22793857
Head Neck. 2020 Nov;42(11):3375-3388
pubmed: 32830404
Psychol Bull. 1979 Mar;86(2):420-8
pubmed: 18839484
Head Neck. 2013 Sep;35(9):1331-8
pubmed: 22907791
Cancer Epidemiol Biomarkers Prev. 2009 Dec;18(12):3368-74
pubmed: 19959684
J Med Internet Res. 2012 Nov 14;14(6):e152
pubmed: 23151820
Musculoskeletal Care. 2016 Jun;14(2):77-86
pubmed: 26311320
Oral Oncol. 2012 Dec;48(12):1276-80
pubmed: 22818822
Oncol Nurs Forum. 2017 Nov 1;44(6):719-728
pubmed: 29052663
Head Neck. 2014 Feb;36(2):299-308
pubmed: 23554002
N Engl J Med. 2010 Jul 1;363(1):24-35
pubmed: 20530316
Cogn Behav Ther. 2011;40(2):82-97
pubmed: 25155812
Eur Arch Otorhinolaryngol. 2012 Apr;269(4):1233-9
pubmed: 21909656
Cancer Metastasis Rev. 2003 Mar;22(1):25-38
pubmed: 12716034
CA Cancer J Clin. 2016 May;66(3):203-39
pubmed: 27002678
Psychother Psychosom. 2009;78(5):275-84
pubmed: 19602916
Eur J Oncol Nurs. 2017 Aug;29:125-134
pubmed: 28720259
J Med Internet Res. 2011 Aug 05;13(3):e52
pubmed: 21821503
Cancer. 2019 Apr 1;125(7):1176-1184
pubmed: 30521075
J Gen Intern Med. 2012 May;27(5):520-6
pubmed: 22127797
Braz Oral Res. 2006 Oct-Dec;20(4):290-6
pubmed: 17242787
J Craniomaxillofac Surg. 2012 Jun;40(4):e99-102
pubmed: 21733701
J Support Oncol. 2008 Mar;6(3):125-31
pubmed: 18402304
Head Neck. 2015 Sep;37(9):1358-67
pubmed: 24832623
Health Psychol. 2006 May;25(3):282-91
pubmed: 16719599
J Behav Med. 2013 Feb;36(1):75-85
pubmed: 22322910
J Adv Nurs. 2008 Jul;63(1):85-93
pubmed: 18598253
Semin Oncol Nurs. 2009 Aug;25(3):222-30
pubmed: 19635401
J Oral Pathol Med. 2022 Oct;51(9):763-770
pubmed: 35998115
Support Care Cancer. 2021 Jun;29(6):3267-3275
pubmed: 33106976
Health Psychol. 2006 Sep;25(5):626-34
pubmed: 17014280
Head Neck. 2019 Jun;41(6):1725-1737
pubmed: 30636188
J Cancer Educ. 2018 Aug;33(4):847-856
pubmed: 28155041
JAMA Otolaryngol Head Neck Surg. 2015 Jun;141(6):519-25
pubmed: 25950859
Support Care Cancer. 2014 Nov;22(11):2917-26
pubmed: 24839941
Med Oral Patol Oral Cir Bucal. 2008 Nov 01;13(11):E735-41
pubmed: 18978717
Annu Rev Public Health. 2009;30:273-92
pubmed: 19296777
West J Nurs Res. 2009 Nov;31(7):889-904
pubmed: 19858525
Oral Oncol. 2017 Feb;65:57-64
pubmed: 28109469
Ann Oncol. 2017 Oct 1;28(10):2386-2398
pubmed: 28633362
Health Expect. 2003 Mar;6(1):3-18
pubmed: 12603624
Asian Pac J Cancer Prev. 2010;11(1):187-91
pubmed: 20593955
Eur J Cancer Care (Engl). 2015 Sep;24(5):748-60
pubmed: 26250705
Int J Oral Maxillofac Surg. 2006 Jul;35(7):581-7
pubmed: 16697144
Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Jan;93(1):35-8
pubmed: 11805775
Oral Oncol. 2018 Jul;82:115-121
pubmed: 29909885
Oral Surg Oral Med Oral Pathol Oral Radiol. 2017 Jan;123(1):67-75
pubmed: 27876377
J Behav Med. 2008 Feb;31(1):81-92
pubmed: 17963038
J Psychiatr Res. 2015 Sep;68:106-13
pubmed: 26228408
Psychol Res Behav Manag. 2018 Sep 12;11:383-394
pubmed: 30254498
J Med Internet Res. 2011 Apr 14;13(2):e32
pubmed: 21493191
J Natl Compr Canc Netw. 2020 Jul;18(7):873-898
pubmed: 32634781
Head Neck. 2006 Aug;28(8):697-704
pubmed: 16721736
Head Neck. 2013 Dec;35(12):1707-12
pubmed: 24142523
Nepal J Epidemiol. 2016 Dec 31;6(4):613-619
pubmed: 28804673
Support Care Cancer. 2016 May;24(5):2333-2340
pubmed: 26619995
Br J Health Psychol. 2010 May;15(Pt 2):265-88
pubmed: 19586583
BMJ. 1994 Apr 9;308(6934):961-6
pubmed: 8173406
Br J Health Psychol. 2008 Sep;13(Pt 3):525-35
pubmed: 17631695
Oral Oncol. 2005 Aug;41(7):687-93
pubmed: 15927521