Connecting Audio and Radio Sensing Systems to Improve Care at Home

NCT05344950 | Completed

• 1 other identifier: LCCC2123
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to assess the usability of the innovative Audio + Radio (AURA) system in enhancing personalized supportive care for cancer patients and caregivers during the post-ostomy care transition by collecting information on patient's daily activities and answers to survey questionnaire, and enabling access to this information through a voice assistant device.

Conditions

Colorectal Cancer; Bladder Cancer; Ovarian Cancer; Cervical Cancer; Uterine Cancer

Keywords

ostomy (colostomy, urostomy, and ileostomy); symptom; self-management; caregiving; family research; telehealth; self-efficacy; quality of life; post-treatment care transition

Outcome Measures

Primary Outcomes (2)

• Satisfaction with the AURA system

  Satisfaction with the AURA system will be assessed by the 9-item Participant Satisfaction Scale measuring the level of program satisfaction ranging from 1=not satisfied to 5=extremely satisfied. Higher total score indicates greater program satisfaction.

  1-month followup survey

• Perceived ease of use of the PRISMS program

  Perceived ease of use of the AURA system will be assessed by the 23-item Usability Scale measuring the ease of use in three aspects: general, content, and navigation. The scales range from 1=strongly disagree to 5=strongly agree. Higher total score indicates greater ease of use.

  1-month followup survey

Study Arms (1)

AURA

In addition to usual care, participants assigned to this arm will have access to our Audio + Radio (AURA) system.

Behavioral: Audio + Radio (AURA)

Interventions

Audio + Radio (AURA) BEHAVIORAL

Participants will receive personalized self-care information based on their symptoms and signs of complications (e.g., fatigue) from interacting with our voice assistant device, connected to a system that integrating the patient-reported outcome and objective data from passive RF sensing to provide continuous monitoring of patients' symptoms and complications after they are discharged home.

AURA

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects receive treatment and their caregivers partners.

You may qualify if:

• Phase I: The investigators will only be recruiting patients for this phase
• Patients must:
• have been surgically treated for colorectal or bladder cancer with curative intent;
• have had an ostomy with curative intent for at least 90 days;
• be able to read and speak English;
• be 18 years or older;
• Phase II: The investigators will be recruiting patients and caregivers as a dyad for this phase
• Patients must:
• have been surgically treated for colorectal or bladder cancer with curative intent;
• be within one month of hospital discharge of a newly created ostomy with curative intent;
• be able to read and speak English;
• be 18 years or older;
• have a caregiver who is willing to participate in the study;
• Caregivers must:
• be 18 years or older;

You may not qualify if:

• Patients and their caregivers will be excluded if they:
• are unable to read, speak, or understand English;
• have more than one type of ostomy;
• have other cancer diagnosis (excluding non-melanomatous skin cancer); or
• have cognitive impairment (assessed by the Short Portable Mental Status Questionnaire).

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• U.S. National Science Foundation: collaborator
• National Library of Medicine (NLM): collaborator

Study Sites (2)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

UT Health San Antonio MD Anderson Cancer Center

San Antonio, Texas, 78229, United States

Location

Related Links

• Clinical trials at UNC Lineberger

MeSH Terms

Conditions

Colorectal Neoplasms; Urinary Bladder Neoplasms; Ovarian Neoplasms; Uterine Cervical Neoplasms; Uterine Neoplasms

Interventions

Radio

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Cervical Diseases; Uterine Diseases

Intervention Hierarchy (Ancestors)

Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture

Study Officials

• Shahriar Nirjon, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 25, 2022
• Study Start: March 21, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)