Study Buddy (an ECA Oncology Trial Advisor) for Cancer Trials
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|ClinicalTrials.gov Identifier: NCT02742740|
Recruitment Status : Completed
First Posted : April 19, 2016
Last Update Posted : June 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Patient Satisfaction Patient Compliance Guideline Adherence||Behavioral: Chemo Buddy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|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 :||September 1, 2017|
|Actual Primary Completion Date :||April 30, 2018|
|Actual Study Completion Date :||April 30, 2018|
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.
- treatment protocol adherence [ Time Frame: 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].
- Subject Satisfaction [ Time Frame: assessed at 2 months ]assessed by questionnaire
- Number of adverse events [ Time Frame: assessed at 2 months ]as reported through tablet and directly to clinic by patient
- time to detect and resolve adverse events [ Time Frame: assessed at 2 months ]as reported through tablet and directly to clinic by patient
- adverse event false alarm rate [ Time Frame: assessed at 2 months ]as reported through tablet and directly to clinic by patient
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02742740
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Michael Paasche-Orlow, MD||Boston University|