Clinical trial NCT03427177: Mychoice: Testing an Interactive mHealth Tool
Official title: Mychoice: Testing an Interactive mHealth Tool to Enhance Communication and Informed Decision Making About Clinical Trial Participation in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conflict
Decisional Conflict
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: University of Pennsylvania
name: Temple University
name: Thomas Jefferson University
First posted: 2018-02-09
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Investigators aim to test a culturally diverse and patient guided mHealth decision tool called mychoice, which allows patients to explore their concerns and questions related to clinical trial participation, as well as create a customized and personalized set of questions to enhance patient-provider communication and increase informed decision making. This study employs a mixed-methods approach using both qualitative and quantitative data to evaluate the effectiveness of the mychoice intervention for patients and to explore the provider and organizational factors that impact implementation. A randomized controlled trial will be performed with 270 participants in order to determine the acceptability and feasibility of the intervention, as well as its effects on self-efficacy in discussing clinical trial participation with providers, leading to enhanced informed decision-making. A secondary aim of the study is to evaluate the implementation of the intervention in clinical settings. Implementation evaluation will occur using surveys of medical staff whose patients are participating in the study. These surveys will assess institutional facilitators and barriers to study implementation. Investigators will also conduct cognitive de-briefing interviews after the intervention is completed with key stakeholders at the participating institutions, which will inform a larger implementation study in the future.

Detailed description: Evidence shows that although clinical trials are aimed at producing new strategies for reducing cancer morbidity and mortality, participation remains sub-optimal for all populations, especially those from racial and ethnic groups. Although some interventions have been found to be effective at enhancing participation, few studies have tested tailored communication activities using innovative communication techniques (perceptual mapping) with aims to address barriers and facilitators for patients and facilitate more engaged discussions with their providers in real world settings.

Participation in clinical trials is a serious and complex decision, and many patients of all races and backgrounds have limited knowledge and understanding of clinical trials as a treatment option. Although research has been conducted to explore the barriers to participation, there has been a call for more intervention research to address these barriers. A fundamental aspect of patient focused interventions is an exploration of their personal questions and concerns, without which it is difficult for patients to become empowered to participate in an informed or shared decision making process. However, there remains limited empirical research to suggest which messages are most salient to a diverse range of patients to improve decision making, and how decision tools can be tailored to enhance patient-provider communication. This research will provide insight into that process when the decision is participation in clinical trials.

Evidence shows that ethnic and racial minorities are significantly underrepresented in clinical trials, which is critical to producing new strategies for reducing cancer morbidity and mortality for all populations. Recognizing the complexity of barriers to participation in clinical trials, research has focused on potential strategies to enhance participation. Interventions have shown that provider referrals of minority patients, community outreach, acknowledging and addressing issues of trust, flexibility in intervention methods, and population targeted materials are effective. Few studies, however, have tested tailored communication activities to address barriers and facilitators for patients using innovative communication techniques in real world settings - meaning ways these activities can be integrated into the healthcare workflow - or addressed the unique needs of racial and ethnic minorities.

The mychoice communication tool begins to prepare patients to participate in a personal and tailored discussion with their provider about clinical trials as a potential treatment option. The tool is also customized to address the concerns of those least likely to participate, instead of providing a more general look at clinical trials- a common trait of other available tools. Previous research has shown that patient education before the first oncologist visit improves knowledge, attitudes, and preparation for decision making about clinical trials and integrating these tools into the clinical encounter is critical. In addition, using innovative communication techniques (perceptual mapping and vector modeling) to validate and explore notable messages across diverse cancer patients provided new insights into tailoring messages and personalizing patient/provider communication. Insight gained from validation of the intervention will improve the decision making process and inform a large scale integration of mychoice to affect patient perceptions and increase willingness to participate in clinical trials, especially in minority patients.

In addition, Investigators will assess barriers to implementation when introducing the tool in diverse cancer centers, each with different protocols and patient populations, to inform a future proposal. Using the Consolidated Framework for Implementation Science (CFIR), one of the predominant implementation science research frameworks, we will focus on five domains: intervention characteristics, outer settings, inner setting, characteristics of individuals (patients and providers), and process. Implementation science is becoming an important component of intervention implementation and we aim to use this framework to ensure success.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or over
* Active diagnosis of invasive cancer (any diagnoses), pre or post chemo/radiation/surgery
* Able to speak and read English

Exclusion Criteria:

* Participated in a therapeutic trial in the past

Primary outcomes:
measure: Perceived Efficacy in Patient-Physician Interactions (PEPPI) Self-Efficacy Scale- Outcome Measure at Baseline, Post-test and One Month Follow-up
timeFrame: Baseline and post-test (both occur on same day, day 1), one month follow-up
Secondary outcomes:
measure: CollaboRATE Perceived Shared Decision Making Scale
timeFrame: 1 month follow-up
measure: Shared Decision Making (SDM Q-9) Scale
timeFrame: 1 month follow-up
measure: Ottawa Decisional Conflict
timeFrame: Baseline and post-test (both occur on same day, day 1), one month follow-up
measure: Preparation for Decision Making (PrepDM) Scale
timeFrame: Post test (day 1)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Health System
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Linda Fleisher, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Temple
name: Sarah Bass, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baquet CR, Henderson K, Commiskey P, Morrow JN. Clinical trials: the art of enrollment. Semin Oncol Nurs. 2008 Nov;24(4):262-9. doi: 10.1016/j.soncn.2008.08.006.
citation: Comis R, Crowley J. Baseline study of patient accrual onto publically sponsored U.S. cancer clinical trials: an analysis conducted for the global access project of the national patient advocate foundation, 2006.
citation: Michaels, M.S., S; ENACCT and Community-Campus Partnerships for Health, Communities as Partners in Cancer Clinical Trials: Changing Research, Practice and Policy. 2008: Silver Springs, MD.
citation: Weinberg, A.D. Eliminating Disparities in Clinical Trials. cited 2009 June 4th, 2009; Version 2: Available from: http://www.bcm.edu/edict/home.html.
citation: Colon-Otero G, Smallridge RC, Solberg LA Jr, Keith TD, Woodward TA, Willis FB, Dunn AN. Disparities in participation in cancer clinical trials in the United States : a symptom of a healthcare system in crisis. Cancer. 2008 Feb 1;112(3):447-54. doi: 10.1002/cncr.23201.
citation: Gadegbeku CA, Stillman PK, Huffman MD, Jackson JS, Kusek JW, Jamerson KA. Factors associated with enrollment of African Americans into a clinical trial: results from the African American study of kidney disease and hypertension. Contemp Clin Trials. 2008 Nov;29(6):837-42. doi: 10.1016/j.cct.2008.06.001. Epub 2008 Jun 27.
citation: Katz RV, Wang MQ, Green BL, Kressin NR, Claudio C, Russell SL, Sommervil C. Participation in biomedical research studies and cancer screenings: perceptions of risks to minorities compared with whites. Cancer Control. 2008 Oct;15(4):344-51. doi: 10.1177/107327480801500409.
citation: Shavers VL, Lynch CF, Burmeister LF. Factors that influence African-Americans' willingness to participate in medical research studies. Cancer. 2001 Jan 1;91(1 Suppl):233-6. doi: 10.1002/1097-0142(20010101)91:1+3.0.co;2-8.
citation: Mills EJ, Seely D, Rachlis B, Griffith L, Wu P, Wilson K, Ellis P, Wright JR. Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors. Lancet Oncol. 2006 Feb;7(2):141-8. doi: 10.1016/S1470-2045(06)70576-9.
citation: Todd AM, Laird BJ, Boyle D, Boyd AC, Colvin LA, Fallon MT. A systematic review examining the literature on attitudes of patients with advanced cancer toward research. J Pain Symptom Manage. 2009 Jun;37(6):1078-85. doi: 10.1016/j.jpainsymman.2008.07.009. Epub 2009 May 5.
citation: Evelyn B, Toigo T, Banks D, Pohl D, Gray K, Robins B, Ernat J. Participation of racial/ethnic groups in clinical trials and race-related labeling: a review of new molecular entities approved 1995-1999. J Natl Med Assoc. 2001 Dec;93(12 Suppl):18S-24S.
citation: Stewart JH, Bertoni AG, Staten JL, Levine EA, Gross CP. Participation in surgical oncology clinical trials: gender-, race/ethnicity-, and age-based disparities. Ann Surg Oncol. 2007 Dec;14(12):3328-34. doi: 10.1245/s10434-007-9500-y. Epub 2007 Aug 8.
citation: Rivera-Goba MV, Dominguez DC, Stoll P, Grady C, Ramos C, Mican JM. Exploring decision-making of HIV-infected Hispanics and African Americans participating in clinical trials. J Assoc Nurses AIDS Care. 2011 Jul-Aug;22(4):295-306. doi: 10.1016/j.jana.2010.10.007. Epub 2011 Jan 21.
citation: Symonds RP, Lord K, Mitchell AJ, Raghavan D. Recruitment of ethnic minorities into cancer clinical trials: experience from the front lines. Br J Cancer. 2012 Sep 25;107(7):1017-21. doi: 10.1038/bjc.2012.240. Epub 2012 May 31.
citation: Schmotzer GL. Barriers and facilitators to participation of minorities in clinical trials. Ethn Dis. 2012 Spring;22(2):226-30.
citation: Advani AS, Atkeson B, Brown CL, Peterson BL, Fish L, Johnson JL, Gockerman JP, Gautier M. Barriers to the participation of African-American patients with cancer in clinical trials: a pilot study. Cancer. 2003 Mar 15;97(6):1499-506. doi: 10.1002/cncr.11213.
citation: Goldberg D. The case for Eliminating Disparities in Clinical Trials. J Cancer Educ. 2009;24(2 Suppl):S34-8. doi: 10.1007/BF03182310. No abstract available.
citation: Gross CP. Racial disparities in clinical trial enrolment. Lancet. 2008 Nov 15;372(9651):1713-4. doi: 10.1016/S0140-6736(08)61714-6. No abstract available.
citation: Newman LA, Roff NK, Weinberg AD. Cancer clinical trials accrual: missed opportunities to address disparities and missed opportunities to improve outcomes for all. Ann Surg Oncol. 2008 Jul;15(7):1818-9. doi: 10.1245/s10434-008-9869-2. Epub 2008 Apr 19. No abstract available.
citation: Ford JG, Howerton MW, Lai GY, Gary TL, Bolen S, Gibbons MC, Tilburt J, Baffi C, Tanpitukpongse TP, Wilson RF, Powe NR, Bass EB. Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review. Cancer. 2008 Jan 15;112(2):228-42. doi: 10.1002/cncr.23157.
citation: Gul RB, Ali PA. Clinical trials: the challenge of recruitment and retention of participants. J Clin Nurs. 2010 Jan;19(1-2):227-33. doi: 10.1111/j.1365-2702.2009.03041.x.
citation: Markman M, Petersen J, Montgomery R. An examination of the influence of patient race and ethnicity on expressed interest in learning about cancer clinical trials. J Cancer Res Clin Oncol. 2008 Jan;134(1):115-8. doi: 10.1007/s00432-007-0263-4. Epub 2007 Jun 28.
citation: Adderley-Kelly B, Green PM. Strategies for successful conduct of research with low-income African American populations. Nurs Outlook. 2005 May-Jun;53(3):147-52. doi: 10.1016/j.outlook.2005.03.004.
citation: Knobf MT, Juarez G, Lee SY, Sun V, Sun Y, Haozous E. Challenges and strategies in recruitment of ethnically diverse populations for cancer nursing research. Oncol Nurs Forum. 2007 Nov;34(6):1187-94. doi: 10.1188/07.ONF.1187-1194.
citation: Lai GY, Gary TL, Tilburt J, Bolen S, Baffi C, Wilson RF, Howerton MW, Gibbons MC, Tanpitukpongse TP, Powe NR, Bass EB, Ford JG. Effectiveness of strategies to recruit underrepresented populations into cancer clinical trials. Clin Trials. 2006;3(2):133-41. doi: 10.1191/1740774506cn143oa.
citation: Davis SW, Fleisher L, Ter Maat J, Muha C, Laepke K. Treatment and clinical trials decisionmaking: the impact of the Cancer Information Service. Part 5. J Health Commun. 1998;3 Suppl:71-85. doi: 10.1080/108107398127265.
citation: Meropol NJ, Wong YN, Albrecht T, Manne S, Miller SM, Flamm AL, Benson AB 3rd, Buzaglo J, Collins M, Egleston B, Fleisher L, Katz M, Kinzy TG, Liu TM, Margevicius S, Miller DM, Poole D, Roach N, Ross E, Schluchter MD. Randomized Trial of a Web-Based Intervention to Address Barriers to Clinical Trials. J Clin Oncol. 2016 Feb 10;34(5):469-78. doi: 10.1200/JCO.2015.63.2257. Epub 2015 Dec 23.
citation: Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
citation: Denicoff AM, McCaskill-Stevens W, Grubbs SS, Bruinooge SS, Comis RL, Devine P, Dilts DM, Duff ME, Ford JG, Joffe S, Schapira L, Weinfurt KP, Michaels M, Raghavan D, Richmond ES, Zon R, Albrecht TL, Bookman MA, Dowlati A, Enos RA, Fouad MN, Good M, Hicks WJ, Loehrer PJ Sr, Lyss AP, Wolff SN, Wujcik DM, Meropol NJ. The National Cancer Institute-American Society of Clinical Oncology Cancer Trial Accrual Symposium: summary and recommendations. J Oncol Pract. 2013 Nov;9(6):267-76. doi: 10.1200/JOP.2013.001119. Epub 2013 Oct 15.
citation: Maly RC, Frank JC, Marshall GN, DiMatteo MR, Reuben DB. Perceived efficacy in patient-physician interactions (PEPPI): validation of an instrument in older persons. J Am Geriatr Soc. 1998 Jul;46(7):889-94. doi: 10.1111/j.1532-5415.1998.tb02725.x.
citation: Bennett C, Graham ID, Kristjansson E, Kearing SA, Clay KF, O'Connor AM. Validation of a preparation for decision making scale. Patient Educ Couns. 2010 Jan;78(1):130-3. doi: 10.1016/j.pec.2009.05.012. Epub 2009 Jun 26.
citation: O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
citation: Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.
citation: Barr PJ, Thompson R, Walsh T, Grande SW, Ozanne EM, Elwyn G. Correction: the psychometric properties of CollaboRATE: a fast and frugal patient-reported measure of the shared decision-making process. J Med Internet Res. 2015 Feb 6;17(2):e32. doi: 10.2196/jmir.4272. No abstract available.
citation: National Institutes for Health (NIH). NIH Demographics form Version 2.0.
citation: NCI's Health and Information National Trend Study. Computer Facility. PIES Study (Diefenbach et al)
citation: Morris NS, MacLean CD, Chew LD, Littenberg B. The Single Item Literacy Screener: evaluation of a brief instrument to identify limited reading ability. BMC Fam Pract. 2006 Mar 24;7:21. doi: 10.1186/1471-2296-7-21.
citation: Hoerger M, Chapman BP, Mohile SG, Duberstein PR. Development and psychometric evaluation of the Decisional Engagement Scale (DES-10): A patient-reported psychosocial survey for quality cancer care. Psychol Assess. 2016 Sep;28(9):1087-100. doi: 10.1037/pas0000294.