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

• Sponsor: Boston Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02742740
• Collaborator: Northeastern University (Other), National Cancer Institute (NCI) (NIH)
• Enrollment: 4
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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	N/A

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).

Study Design

• Study Type: Interventional
• 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: Sep 1, 2017
• Actual Primary Completion Date: Apr 30, 2018
• Actual Study Completion Date: Apr 30, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. treatment protocol adherence [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 [assessed at 2 months]

   assessed by questionnaire

2. Number of adverse events [assessed at 2 months]

   as reported through tablet and directly to clinic by patient

3. time to detect and resolve adverse events [assessed at 2 months]

   as reported through tablet and directly to clinic by patient

4. adverse event false alarm rate [assessed at 2 months]

   as reported through tablet and directly to clinic by patient

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Medical Center	Boston	Massachusetts	United States	02118

Sponsors and Collaborators

• Boston Medical Center
• Northeastern University
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Michael Paasche-Orlow, MD, Boston University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Paasche-Orlow, Associate Professor, Boston Medical Center
• ClinicalTrials.gov Identifier: NCT02742740
• Other Study ID Numbers: H-34989; 5R01CA158219-05
• First Posted: Apr 19, 2016
• Last Update Posted: Jun 25, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 25, 2018