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

Patient Satisfaction Clinical Trial

Official title:

Embodied Conversational Agent (ECA) as an Oncology Trial Advisor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742740
• Other study ID #: H-34989
• Secondary ID: 5R01CA158219-05
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: June 2018
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Guideline Adherence
• Patient Compliance
• Patient Satisfaction

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston Medical Center	National Cancer Institute (NCI), Northeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment protocol adherence	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].	up to 8 weeks
Secondary	Subject Satisfaction	assessed by questionnaire	assessed at 2 months
Secondary	Number of adverse events	as reported through tablet and directly to clinic by patient	assessed at 2 months
Secondary	time to detect and resolve adverse events	as reported through tablet and directly to clinic by patient	assessed at 2 months
Secondary	adverse event false alarm rate	as reported through tablet and directly to clinic by patient	assessed at 2 months