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

NCT02742740 | Completed

• 2 other identifiers: H-349895R01CA158219-05
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Satisfaction; Patient Compliance; Guideline Adherence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Subject Satisfaction

  assessed at 2 months

• Number of adverse events

  assessed at 2 months

• time to detect and resolve adverse events

  assessed at 2 months

• adverse event false alarm rate

  assessed at 2 months

Study Arms (2)

Control

NO INTERVENTION

Standard of care for chemotherapy treatment.

Chemo Buddy

EXPERIMENTAL

Subject receives instructions on how to use the personalized touch screen tablet and takes it home for 2 months.

Behavioral: Chemo Buddy

Interventions

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.

Chemo Buddy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Patient Satisfaction; Patient Compliance

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Patient Acceptance of Health Care

Study Officials

• Michael Paasche-Orlow, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 19, 2016
• Study Start: September 1, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: June 25, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)