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Study Buddy (an ECA Oncology Trial Advisor) for Cancer Trials

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02742740
Recruitment Status : Completed
First Posted : April 19, 2016
Last Update Posted : June 25, 2018
Sponsor:
Collaborators:
Northeastern University
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Michael Paasche-Orlow, Boston Medical Center

Brief Summary:
The Study Buddy ECA acts as an advisor to patients on chemotherapy regimens, promoting protocol adherence and retention, providing anticipatory guidance and answering questions, serving as a conduit to capture information about complaints or adverse events, providing a venue for communicating about updates. The Study Buddy will use the web-based ECA infrastructure developed for use on another project. We will use web browsers on tablets provided to study participants to access the Study Buddy, providing anywhere, anytime access to its functions. Usability metrics will include session time, satisfaction, and error rates.

Condition or disease Intervention/treatment Phase
Patient Satisfaction Patient Compliance Guideline Adherence Behavioral: Chemo Buddy Not Applicable

Detailed Description:

Subjects will be identified from among patients on chemotherapy regimens at BMC. With the provider's approval, we will recruit patients for this study.

All subjects will be enrolled for 2 months. After consent, we will collect baseline data. Baseline data is collected after enrollment and before randomization. Baseline data includes:

sociodemographic data PROMIS Mental and Social health the PHQ-9 clinical factors such as medical diagnosis (cancer type and stage) the Short Assessment of Health Literacy-English the Short Portable Mental Status Questionnaire (SPMSQ) for cognitive impairment the Need For Cognition scale contact numbers of two friends or family members who will assist us in establishing contact, if necessary.

The exit interview will be conducted 2 months after the baseline interview, with windows of 2 weeks plus or minus that date. Study staff will attempt to coincide this interview with a clinical visit, to minimize inconvenience for the subject.

Data collected at the exit interview will include:

PROMIS Mental and Social health the PHQ-9 Satisfaction with ECA

Review of the subject's medical chart will be performed bi-weekly while the subject is enrolled. Chart review will be performed by a staff member who is blinded to the subject's group (intervention vs control).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Embodied Conversational Agent (ECA) as an Oncology Trial Advisor
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Arm Intervention/treatment
No Intervention: Control
Standard of care for chemotherapy treatment.
Experimental: Chemo Buddy
Subject receives instructions on how to use the personalized touch screen tablet and takes it home for 2 months.
Behavioral: Chemo Buddy
The Study Buddy ECA acts as an advisor to patients on chemotherapy regimens, promoting protocol adherence and retention, providing anticipatory guidance and answering questions, serving as a conduit to capture information about complaints or adverse events, providing a venue for communicating about updates.




Primary Outcome Measures :
  1. treatment protocol adherence [ Time Frame: up to 8 weeks ]
    How well does the subject adhere to treatment protocol. This will be defined by the number of treatment visits attended/ number of treatment visits scheduled [excluding any treatment visits that have been cancelled by the clinicians].


Secondary Outcome Measures :
  1. Subject Satisfaction [ Time Frame: assessed at 2 months ]
    assessed by questionnaire

  2. Number of adverse events [ Time Frame: assessed at 2 months ]
    as reported through tablet and directly to clinic by patient

  3. time to detect and resolve adverse events [ Time Frame: assessed at 2 months ]
    as reported through tablet and directly to clinic by patient

  4. adverse event false alarm rate [ Time Frame: assessed at 2 months ]
    as reported through tablet and directly to clinic by patient



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. speaks English fluently
  2. is able to independently consent into this study and parent cancer study
  3. has adequate corrected vision to use the ECA system (based on a 1-minute functional screener)
  4. has adequate hearing to use the ECA system

Exclusion Criteria:

  1. suicidal or homicidal
  2. currently in police custody
  3. do not live in the Boston area
  4. plan on leaving the Boston area for more than 4 weeks in the next 6 months
  5. score 6 or less on the SPMSQ screening test

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): NCT02742740


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Northeastern University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Michael Paasche-Orlow, MD Boston University
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Responsible Party: Michael Paasche-Orlow, Associate Professor, Boston Medical Center
ClinicalTrials.gov Identifier: NCT02742740    
Other Study ID Numbers: H-34989
5R01CA158219-05 ( U.S. NIH Grant/Contract )
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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