Conversational Agents to Improve Quality of Life in Palliative Care

NCT02750865 | Completed DMC

• 2 other identifiers: H-348771R01NR016131
• Study Type: interventional
• Target: 367
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators will advance research on the development of easy to use technologies to empower patients. This is a scalable approach that has a significant potential to reduce suffering for palliative care patients and their caregivers. The investigators will adapt existing tested empathic conversational agents (ECA) for home-based cancer care management and inpatient bedside counseling to provide the following functions:

1. 1.medication counseling;
2. 2.physical activity promotion;
3. 3.symptom management and continual screening for adverse events; and
4. 4.alleviation of stress and anxiety
5. 5.spiritual needs assessment; and
6. 6.advanced care planning.

Conditions

Palliative Care

Keywords

biomedical technology; palliative care

Outcome Measures

Primary Outcomes (1)

• Quality of Life of palliative cancer care participants

  QOL will be assessed using QLQ-C15-PAL, a 15-scale-item instrument designed to assess the quality of life of participants.

  assessed monthly up to 6 months

Secondary Outcomes (14)

• Palliative Care services utilization

  assessed monthly up to 6 months

• Hospital utilization

  assessed at 6 months

• Cost

  assessed at 6 months

• Mental health

  assessed at enrollment and at 6 months

• Patient activation

  assessed at enrollment and at 6 months

Study Arms (2)

Control Usual Care

NO INTERVENTION

In this arm the subject receives usual care and just completes the baseline interview, monthly telephone surveys about their quality of life, and the exit interview at 6 months after enrollment.

Embodied Conversational Agent (ECA)

EXPERIMENTAL

In this arm the subject is trained how to use a tablet device which they take home for the duration of the study. These subjects complete the baseline interview, monthly telephone surveys about their quality of life, and the exit interview at 6 months after enrollment.

Behavioral: Embodied Conversational Agent (ECA)

Interventions

Embodied Conversational Agent (ECA) BEHAVIORAL

The ECA is a computer generated character who will interact with the subject on a daily basis via a touch-screen tablet. The system is designed to provide the following functions: (1) medication counseling; (2) physical activity promotion; (3) symptom management and continual screening for adverse events; and (4) alleviation of stress and anxiety. The investigators will augment the system to include: (5) spiritual needs assessment; and (6) advanced care planning.

Embodied Conversational Agent (ECA)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• English speaking
• Able to independently consent to be in the study
• Has adequate corrected vision to be able to use the ECA system (based on a 1-minute ECA functional screener)
• Has adequate hearing to be able to use the ECA system (headphones will be available)
• Has a health care provider who endorses the existence of a potentially life-limiting condition and endorses that it would not be a surprise if the patient died within 12 months (PATIENT-SUBJECTS only)

You may not qualify if:

• Enrolled in hospice
• Already being followed by the Palliative Care team
• Suicidal or homicidal
• 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
• Not able to use the ECA tablet computer

Sponsors & Collaborators

• Boston Medical Center: lead
• Northeastern University: collaborator
• Boston University: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Study Officials

• Julien Dedier, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

• Michael Paasche-Orlow, MD, MPH

  Tufts Medical Center

  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: SPONSOR

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 26, 2016
• Study Start: August 2, 2017
• Primary Completion: October 24, 2022
• Study Completion: October 24, 2022
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)