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

NCT ID: NCT02742740

Last Updated: 2018-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-04-30

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).

Conditions

Patient Satisfaction; Patient Compliance; Guideline Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

Standard of care for chemotherapy treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Chemo Buddy

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

Group Type: EXPERIMENTAL

Chemo Buddy

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northeastern University

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael Paasche-Orlow

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Paasche-Orlow, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

5R01CA158219-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-34989

Identifier Type: -

Identifier Source: org_study_id