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BRIEF TITLE: Pilot Testing for Post-Cystectomy mHealth Tool to Improve Perioperative Care

Pilot Testing for Post-Cystectomy mHealth Tool to Improve Perioperative Care


  • Org Study ID: LCCC1856
  • Secondary ID:
  • NCT ID: NCT03862105
  • NCT Alias:
  • Sponsor: UNC Lineberger Comprehensive Cancer Center - Other
  • Source: UNC Lineberger Comprehensive Cancer Center

Brief Summary

This is a pilot study that involves human subjects undergoing cystectomy surgery for bladder cancer, testing the utilization of a mobile health app that promotes postoperative patient engagement, along with provider monitoring and care. The aim of this pilot study is to assess feasibility and acceptability of an Internet-based mobile health tool following cystectomy discharge. Objectives will be met by assessing weekly adherence, determining acceptability of mobile health questions post-surgery by patients and providers, and by obtaining participant feedback regarding the tool. Complications, re-admissions, and resource utilization will also be monitored throughout the study. The hypothesis is that an mobile health intervention that tracks PROs, provides educational content, and allows real-time feedback via internet-enabled devices has the potential to improve the quality of care delivery and overall patient experience following surgery by decreasing resource utilization and improving symptom control and communication.

Detailed Description


Radical cystectomy will be used as a model to examine the utilization of an electronic,
internet-based mobile health intervention that can prospectively collect PRO data while
providing timely feedback to patients and clinicians. This mobile health intervention will
utilize a well-established platform (Twistle) that can be accessed through multiple
technologies, including laptops, smartphones, and other computer-based systems. The objective
is to evaluate the feasibility of pre-specified Patient Reported Outcomes and educational
content in an existing mobile health communications platform which tracks patient symptoms
and provides real-time feedback to patients and providers following cystectomy discharge.
Patient Reported Outcome questions and responses will be inputted using validated questions
with branching logic to drive feedback based upon responses. The intent of this study is to
evaluate feasibility and acceptability of this mobile health tool following cystectomy
discharge. Usual care will continue in coordination with this intervention.

Overal Status Start Date Phase Study Type
Recruiting March 25, 2019 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Feasibility of the tool (Twistle): percentage of patients using the tool at least once weekly

Primary Outcome 1 - Time Frame: 90 days postoperative

Condition:

  • Invasive Bladder Cancer

Eligibility

Criteria:
Minimum Age: 18 Years Maximum Age: 99 Years Sex: All Gender Based: No

Criteria: Inclusion Criteria:

- Male or female patients with invasive bladder cancer scheduled for radical cystectomy
at UNC within the next 30 days

- English-speaking

- Ability to access the Internet (either themselves or with assistance from their
caregiver)

- Ability to read

- Ability to provide informed consent.

Exclusion Criteria:

- Inability to read

- Inability to provide informed consent

- Severe psychiatric illness

- Cystectomy surgery without cancer diagnosis

- Non-English speaking
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Gender: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Healthy Volunteers: No

Official Information

Name: Angela B Smith, MD,MS,FACS

Role: Principal Investigator

Affiliation: Associate Professor, Dept of Urology, Director of Urologic Oncology

Overall Contact

Name: Dana E Mueller, MPH

Phone: 919-962-4671

Email: dana_mueller@med.unc.edu

Link: UNC Lineberger Comprehensive Cancer Center Clinical Trials

Location

Facility Status Contact
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina 27599
United States
Recruiting Angela B Smith, MD
984-974-1315
angela_smith@med.unc.edu