ConflictNCT03427177
Mychoice: Testing an Interactive mHealth Tool
A study testing mychoice in people with Conflict and Decisional Conflict, run by Fox Chase Cancer Center at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conflict, Decisional Conflict
- What is being tested?
- mychoice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 5 sitesUnited States
- Study dates
- 25 Jun 2018to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participated in a therapeutic trial in the past
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Temple University
Philadelphia, Pennsylvania, 19121
Temple University Health System
Philadelphia, Pennsylvania, 19140
About this study
Official title: Mychoice: Testing an Interactive mHealth Tool to Enhance Communication and Informed Decision Making About Clinical Trial Participation in Cancer Patients
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.
Read the 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.
- Conditions
- Conflict, Decisional Conflict
- Being tested
- mychoice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mychoiceBehavioural
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. It 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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants randomized to the treatment arm of the study will be given the mychoice tool. Receives: Behavioral: mychoice |
| Control | No intervention | Participants randomized to the control arm of the study will be given existing literature from the NCI that describes clinical trials (standard information for newly diagnosed cancer patients). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Efficacy in Patient-Physician Interactions (PEPPI) Self-Efficacy Scale- Outcome Measure at Baseline, Post-test and One Month Follow-up
10-item scale measuring patient confidence in communicating with their physician. Participants respond to each question on a scale of 1 to 5, with 5 representing "very confident,'' and 1 representing "not at all confident." The range of possible scores for the full PEPPI scale is 10 to 50 (50 representing highest patient-perceived self-efficacy).
Measured: Baseline and post-test (both occur on same day, day 1), one month follow-up
Secondary outcomes (4)
CollaboRATE Perceived Shared Decision Making Scale
Measure of patient perceptions of physician effort to discuss concerns, 3 items. There is a possible range of 0-9 for each item.
Higher scores represent more shared decision making.
Measured: 1 month follow-up
Shared Decision Making (SDM Q-9) Scale
Measure of patient perception of shared decision making with provider (12 items). The instrument's statements are rated on a six-point scale from ''completely disagree'' (0) to ''completely agree'' (5).
Higher means indicate higher levels of perceived shared decision making.
Measured: 1 month follow-up
Ottawa Decisional Conflict
13 item measure to determine patient clarity on the risks and benefits of clinical trials, support from friends and family, and patient decision regarding cancer treatment. Items are given a score value of: 0= 'strongly agree'; 2= 'neither agree nor disagree'; 3= 'disagree'; 4= 'strongly disagree' TOTAL SCORE 16 items [items 1-16 are inclusive] are: a) summed; b) divided by 16; and c) multiplied by 25. Scores range from 0 [no decisional conflict] to 100 [extremely high decisional conflict]
Measured: Baseline and post-test (both occur on same day, day 1), one month follow-up
Preparation for Decision Making (PrepDM) Scale
Measures preparedness of patient to make a decision (10 items) on a 1 "not at all" to 5 "a great deal" scale.
Higher means indicated higher perceived level of preparation for decision making.
Measured: Post test (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start25 Jun 2018
- Primary completion21 Jan 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for ConflictStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, University of Pennsylvania, Temple University, Thomas Jefferson University
- Responsible party
- Sponsor
- Investigators
- Linda Fleisher, PhD, Principal investigator, Fox Chase Cancer CenterSarah Bass, PhD, Principal investigator, Temple
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427177
- Sponsor's protocol ID
- 17-8013
- Status last verified
- Dec 2020
- First submitted
- 21 Nov 2017
- Last updated
- 27 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19000600Comis 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.
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.
Weinberg, A.D. Eliminating Disparities in Clinical Trials. cited 2009 June 4th, 2009; Version 2: Available from: http://www.bcm.edu/edict/home.html.
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.
PubMed 18085590Gadegbeku 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.
PubMed 18639652Katz 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.
PubMed 18813202Shavers 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.
PubMed 11148585Mills 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.
PubMed 16455478Todd 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.
PubMed 19419837Evelyn 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.
PubMed 11798060Stewart 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.
PubMed 17682824Rivera-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.
PubMed 21256054Symonds 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.
PubMed 23011540Schmotzer GL. Barriers and facilitators to participation of minorities in clinical trials. Ethn Dis. 2012 Spring;22(2):226-30.
PubMed 22764647
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mychoice: Testing an Interactive mHealth Tool to Enhance Communication and Informed Decision Making About Clinical Trial Participation in Cancer Patients
- ClinicalTrials.gov ID
- NCT03427177
- Acronym / sponsor ID
- 17-8013
- Conditions
- Conflict, Decisional Conflict
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, University of Pennsylvania, Temple University, Thomas Jefferson University
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 21 Jan 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Posted 12 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: mychoiceParticipants randomized to the treatment arm of the study will be given the mychoice tool. |
| Control | No intervention | –Participants randomized to the control arm of the study will be given existing literature from the NCI that describes clinical trials (standard information for newly diagnosed cancer patients). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Participated in a therapeutic trial in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mychoiceThe 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. It 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. | Behavioural | Treatment |
Primary outcome
Perceived Efficacy in Patient-Physician Interactions (PEPPI) Self-Efficacy Scale- Outcome Measure at Baseline, Post-test and One Month Follow-up
Time frame: Baseline and post-test (both occur on same day, day 1), one month follow-up
10-item scale measuring patient confidence in communicating with their physician. Participants respond to each question on a scale of 1 to 5, with 5 representing "very confident,'' and 1 representing "not at all confident." The range of possible scores for the full PEPPI scale is 10 to 50 (50 representing highest patient-perceived self-efficacy).
4 secondary outcomes
CollaboRATE Perceived Shared Decision Making Scale
Time frame: 1 month follow-up
Shared Decision Making (SDM Q-9) Scale
Time frame: 1 month follow-up
Ottawa Decisional Conflict
Time frame: Baseline and post-test (both occur on same day, day 1), one month follow-up
Preparation for Decision Making (PrepDM) Scale
Time frame: Post test (day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19000600Baquet 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.
- BackgroundComis 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.
- BackgroundMichaels, 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.
- BackgroundWeinberg, A.D. Eliminating Disparities in Clinical Trials. cited 2009 June 4th, 2009; Version 2: Available from: http://www.bcm.edu/edict/home.html.
- Background: PubMed 18085590Colon-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.
- Background: PubMed 18639652Gadegbeku 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.
- Background: PubMed 18813202Katz 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.
- Background: PubMed 11148585Shavers 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.
- Background: PubMed 16455478Mills 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.
- Background: PubMed 19419837Todd 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.
- Background: PubMed 11798060Evelyn 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.
- Background: PubMed 17682824Stewart 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Fleisher, PhD principal investigator
Fox Chase Cancer Center
Sarah Bass, PhD principal investigator
Temple
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mychoice in people with Conflict and Decisional Conflict, run by Fox Chase Cancer Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Efficacy in Patient-Physician Interactions (PEPPI) Self-Efficacy Scale- Outcome Measure at Baseline, Post-test and One Month Follow-up (time frame: Baseline and post-test (both occur on same day, day 1), one month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03427177, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.