Clinical trial NCT02742740: Study Buddy (an ECA Oncology Trial Advisor) for Cancer Trials
Official title: Embodied Conversational Agent (ECA) as an Oncology Trial Advisor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Satisfaction
Patient Compliance
Guideline Adherence
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Northeastern University
name: National Cancer Institute (NCI)
First posted: 2016-04-19
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Eligibility 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

Primary outcomes:
measure: treatment protocol adherence
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Subject Satisfaction
timeFrame: assessed at 2 months
measure: Number of adverse events
timeFrame: assessed at 2 months
measure: time to detect and resolve adverse events
timeFrame: assessed at 2 months
measure: adverse event false alarm rate
timeFrame: assessed at 2 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Michael Paasche-Orlow, MD
role: PRINCIPAL_INVESTIGATOR
References: