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Mychoice mHealth Tool

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ClinicalTrials.gov Identifier: NCT03427177
Recruitment Status : Not yet recruiting
First Posted : February 9, 2018
Last Update Posted : June 15, 2018
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Fox Chase Cancer Center
University of Pennsylvania
Temple University
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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 200 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. Results will also investigate whether the tool has enhanced effects on minority patients, particularly African Americans. 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.

Condition or disease Intervention/treatment Phase
Conflict Decisional Conflict Behavioral: mychoice Not Applicable

Detailed Description:

Evidence shows that although clinical trials are aimed at producing new strategies for reducing cancer morbidity and mortality, participation remains suboptimal 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 much 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 the patient-provider communication dyad. 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 are 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 salient 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Mychoice: Testing an Interactive mHealth Tool to Enhance Communication and Informed Decision Making About Clinical Trial Participation in Cancer Patients
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : November 30, 2018

Arm Intervention/treatment
Experimental: Treatment
Participants randomized to the treatment arm of the study will be given the mychoice tool to use prior to meeting with their clinician.
Behavioral: mychoice
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.

No Intervention: Control
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).



Primary Outcome Measures :
  1. Perceived Efficacy in Patient-Physician Interactions (PEPPI) Self-Efficacy Scale- Change from baseline to 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).

  2. Preparation for Decision Making (PrepDM) Scale [ Time Frame: Post test (day 1) ]

    Measures preparedness of patient to make a decision (10 items). a) Items can be summed and scored (sum the 10 items and divide by 10).

    b) Scores can be converted to a 0-100 scale by: subtracting 1 from the summed score in part a) and multiplying by 25.

    Higher scores indicated higher perceived level of preparation for decision making.


  3. Ottawa Decisional Conflict- Measure Change from baseline to post-test and one month follow-up [ Time Frame: Baseline and post-test (both occur on same day, day 1), one month follow-up ]
    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]

  4. Shared Decision Making (SDM Q-9) Scale [ Time Frame: 1 month follow-up ]
    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). Summing up all items leads to a raw total score between 0 and 45. If required, use the imputation of up to two missing items using the mean of the items that were filled out to calculate the raw score. No total score should be calculated if more than two items are missing. Multiplication of the raw score by 20/9 provides a score forced (transformed) to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of SDM.

  5. CollaboRATE Perceived Shared Decision Making Scale [ Time Frame: 1 month follow-up ]
    Measure of patient perceptions of physician effort to discuss concerns, 3 items. Possible range of 0-9. Exclude cases where a response to one or more of the CollaboRATE questions is missing. Calculate the mean of the three CollaboRATE responses for each encounter. Then, calculate the mean of all encounters of interest. This number is the CollaboRATE Score. Higher scores represent more shared decision making.


Secondary Outcome Measures :
  1. Satisfaction with Decision Scale [ Time Frame: 1 month follow-up ]
    Measure of patient satisfaction with their decision about clinical trials (6 items). Higher scores represent more satisfaction with treatment decision. The score for each item is the number circled.

  2. Experience with Clinical Trial Discussions Scale [ Time Frame: 1 month follow up ]
    6-item scale that includes patient self-reported experience about clinical trial discussions with provider. The score for each item is the number circled.

  3. Satisfaction with Patient Materials Scale- Change from baseline to post-test and one month follow-up [ Time Frame: Day 1 post-test, 1 month follow-up ]
    Helpfulness and recommendations of materials (mychoice tool or NCI standard brochure). The score for each item is the number circled. (3 items post; 13 items follow-up)

  4. Ottawa Clinical Trial Intention Scale- Measuring change from baseline to one month follow-up [ Time Frame: Baseline and post-test (both occur on same day, day 1), one month follow-up ]
    Determines whether if a patient was offered a clinical trial, if patient would consider participating (1 item). The 15-point scale Choice Predisposition scale can be scored from 1 (leaning towards yes) to 15 (leaning towards no). The scale can be reclassified as: 1-5 (yes); 6-10 (unsure); 11-15 (no). Team has reduced to an 11-point scale; with 0-3 no, 4-7 unsure, 8-10 yes.

  5. Knowledge of Clinical Trials Scale- Measuring change from baseline to follow-up [ Time Frame: Baseline and post-test (both occur on same day, day 1), one month follow-up ]
    Measures patient's overall knowledge of clinical trials (reduced items; 16) More correct answers indicates higher knowledge of clinical trials.

  6. Patient Self-Advocacy (PSAS) Scale [ Time Frame: Baseline (day 1) ]
    Perceptions and self-reported behaviors about information seeking and provider relationship (12 items). The score provided for each item should be added and divided by 12 to obtain the overall self-advocacy score. Higher scores indicate more self-advocacy.

  7. Decision Engagement (DES-10) Patient Activation Scale- Change from baseline to post-test and one month follow-up [ Time Frame: Baseline (day 1) and one month follow-up ]
    2- scales decision making preference (1 item), Comfort with interacting with physician (10 items). The score provided for each item should be added and divided by 10 to obtain the overall decisional engagement score. Higher scores indicate more decisional engagement.

  8. Clinical Trial Perceptions Measure- Change from baseline to post-test and one month follow-up [ Time Frame: Baseline (day 1) and one month follow-up ]
    Test perceptions over time using perceptual mapping - knowledge, benefits, concerns, perceptions/experiences with cancer treatment, beliefs about health care providers and your health (48 items pre; 31 post; 43 follow up)

  9. Single Item Literacy (SILS) Health Literacy Screener Scale [ Time Frame: Baseline (day 1) ]
    Measures patient's ability to read and correctly interpret medical/health information (1 item). Determine health literacy by the value chosen.

  10. HINTS Technology Use Scale [ Time Frame: Baseline (day 1) ]
    Gauges patient's use of mobile devices, smartphones, computers, and/or tablets (5 items). The score for each item is the number circled.

  11. Cancer and Clinical Trial Experience Scale [ Time Frame: Baseline (day 1) ]
    Measures patient's experience with cancer and clinical trials in both themselves and in family/friends. Cancer type, stage (6 items). No scoring- patients will self-report.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Potentially a candidate for a therapeutic trial within the near future (assessed by participating physician).

Exclusion Criteria:

  • Participated in a therapeutic trial in the past

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427177


Contacts
Contact: Linda Fleisher, PhD 267-425-1584 fleisherl@email.chop.edu
Contact: Deanna Brown 2674251555 brownd17@email.chop.edu

Locations
United States, Pennsylvania
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Carmen Guerra, MD       carmen.guerra@uphs.upenn.edu   
Fox Chase Cancer Center Not yet recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Evelyn Gonzalez       evelyn.gonzalez@fccc.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
Merck Sharp & Dohme Corp.
Fox Chase Cancer Center
University of Pennsylvania
Temple University
Investigators
Principal Investigator: Linda Fleisher, PhD Children's Hospital of Philadelphia

Publications:
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.
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.
National Institutes for Health (NIH). NIH Demographics form Version 2.0.
NCI's Health and Information National Trend Study. Computer Facility. PIES Study (Diefenbach et al)

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03427177     History of Changes
Other Study ID Numbers: 17-014304
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No