Cancer Care Coordination for Chemotherapy Patients

Cancer Clinical Trial

— 4CP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02238951
• Other study ID #: 551190
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: October 2017

Study information

• Verified date: November 2018
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Mobile Health (mHealth)
Participants receive care coordination throughout their chemotherapy treatment using mHealth technology
• No mHealth
Participants receive the same evidence-based care coordination without mHealth technology

Locations

Country	Name	City	State
United States	UC Davis Comprehensive Cancer Care Center	Sacramento	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Davis	Boston University, McKesson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Patient Health Outcomes	Treatment related symptoms; Psychological Distress; Quality of Life	Baseline, 3 months, 6 months
Other	Change in Healthcare Outcomes	Processes of care coordination; Patient engagement; Patient satisfaction	Baseline, 6 months
Other	Change in Healthcare Utilization	Emergency department visits; Unplanned hospitalizations; Unplanned clinic visits	Baseline, 3 months, 6 months
Other	Mobile health usability overtime	Guided interviews with technology group to assess understanding and usability of the mobile technology platform to communicate and coordinate care	2 weeks, 8 weeks
Primary	Change in Patient Health Outcome	Pain	Baseline, 3 months, 6 months
Secondary	Demonstration of a HIPAA-compliant platform to coordinate care overtime	Technology Usability and Acceptance; Patient engagement with technology; Use of electronic medical record features to communicate with providers	Baseline, 6 months