Cancer Care Coordination for Chemotherapy Patients (4CP)

November 15, 2018 updated by: University of California, Davis

Use of mHealth to Support Nurse-directed Care Coordination for Chemotherapy Patients: Improving Health, Healthcare Delivery, and Healthcare Utilization.

The purpose of this study is to compare nurse-led care coordination for persons receiving cancer chemotherapy treatment incorporating mobile health technology to nurse-led care coordination without any mobile health enhancements.

Study Overview

Status

Completed

Conditions

Detailed Description

This study will randomize sixty (60) participants receiving cancer chemotherapy treatment to receive nurse-led care coordination using a HIPAA-compliant mobile health platform compared to no technology-enhanced care coordination.

All participants receive nurse-led care coordination throughout chemotherapy treatment.

RESEARCH AIMS:

  • Demonstration of a HIPAA-compliant social networking platform;
  • Facilitate communication and collaboration among patients with cancer and their care team;
  • Assess patient health outcomes (chemotherapy-related physical and psychological side effects; pain, quality of life and patient satisfaction)
  • Assessment of healthcare utilization including emergency department visits, unplanned clinic visits and hospitalization;
  • For patients assigned to the mobile health care coordination, understanding their experience of use of the technology

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Sacramento, California, United States, 95817
        • UC Davis Comprehensive Cancer Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older
  • Newly diagnosed cancer - any site or stage
  • Initiating chemotherapy
  • Ability to read and write English
  • Manual dexterity sufficient to use a tablet technology
  • Cognitive capacity to participate
  • Preferential recruitment of publicly insured and/or living in rural communities

Exclusion Criteria:

  • Oral chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile Health (mHealth)
Care coordination using mHealth technology enhancements
Participants receive care coordination throughout their chemotherapy treatment using mHealth technology
Other Names:
  • Android-based device
  • Mobile health
  • Patient Health Network
Active Comparator: No mHealth
Care coordination without mHealth enhancements
Participants receive the same evidence-based care coordination without mHealth technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient Health Outcome
Time Frame: Baseline, 3 months, 6 months
Pain
Baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstration of a HIPAA-compliant platform to coordinate care overtime
Time Frame: Baseline, 6 months
  • Technology Usability and Acceptance
  • Patient engagement with technology
  • Use of electronic medical record features to communicate with providers
Baseline, 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient Health Outcomes
Time Frame: Baseline, 3 months, 6 months
  • Treatment related symptoms
  • Psychological Distress
  • Quality of Life
Baseline, 3 months, 6 months
Change in Healthcare Outcomes
Time Frame: Baseline, 6 months
  • Processes of care coordination
  • Patient engagement
  • Patient satisfaction
Baseline, 6 months
Change in Healthcare Utilization
Time Frame: Baseline, 3 months, 6 months
  • Emergency department visits
  • Unplanned hospitalizations
  • Unplanned clinic visits
Baseline, 3 months, 6 months
Mobile health usability overtime
Time Frame: 2 weeks, 8 weeks
Guided interviews with technology group to assess understanding and usability of the mobile technology platform to communicate and coordinate care
2 weeks, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jill G Joseph, MD, PhD, University of California, Davis Betty Irene Moore School of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

September 10, 2014

First Submitted That Met QC Criteria

September 10, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Actual)

November 16, 2018

Last Update Submitted That Met QC Criteria

November 15, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 551190

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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