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
Intervention / Treatment
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:
|
|
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
|
|
Baseline, 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Patient Health Outcomes
Time Frame: Baseline, 3 months, 6 months
|
|
Baseline, 3 months, 6 months
|
|
Change in Healthcare Outcomes
Time Frame: Baseline, 6 months
|
|
Baseline, 6 months
|
|
Change in Healthcare Utilization
Time Frame: Baseline, 3 months, 6 months
|
|
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.
Sponsor
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.