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Completed

NCT Number: NCT02742740

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

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.

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Key information

Conditions

Patient Satisfaction Behavior Guideline Adherence Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Chemo Buddy

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • Northeastern University

Registry information

Official study title

Embodied Conversational Agent (ECA) as an Oncology Trial Advisor

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 19, 2016
Registry last updated
Jun 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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