Study Buddy (an ECA Oncology Trial Advisor) for Cancer Trials
- Conditions
- Patient ComplianceGuideline AdherencePatient Satisfaction
- Interventions
- Behavioral: Chemo Buddy
- Registration Number
- NCT02742740
- Lead Sponsor
- Boston Medical Center
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chemo Buddy Chemo Buddy Subject receives instructions on how to use the personalized touch screen tablet and takes it home for 2 months.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Number of adverse events assessed at 2 months as reported through tablet and directly to clinic by patient
Subject Satisfaction assessed at 2 months assessed by questionnaire
adverse event false alarm rate assessed at 2 months as reported through tablet and directly to clinic by patient
time to detect and resolve adverse events assessed at 2 months as reported through tablet and directly to clinic by patient
Trial Locations
- Locations (1)
Boston Medical Center
🇺🇸Boston, Massachusetts, United States