NCT02238951

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

November 16, 2018

Status Verified

November 1, 2018

Enrollment Period

3.8 years

First QC Date

September 10, 2014

Last Update Submit

November 15, 2018

Conditions

Cancer

Keywords

care coordination, mobile health, chemotherapy, technology

Outcome Measures

Primary Outcomes (1)

  • Change in Patient Health Outcome

    Pain

    Baseline, 3 months, 6 months

Secondary Outcomes (1)

  • Demonstration of a HIPAA-compliant platform to coordinate care overtime

    Baseline, 6 months

Other Outcomes (4)

  • Change in Patient Health Outcomes

    Baseline, 3 months, 6 months

  • Change in Healthcare Outcomes

    Baseline, 6 months

  • Change in Healthcare Utilization

    Baseline, 3 months, 6 months

  • +1 more other outcomes

Study Arms (2)

Mobile Health (mHealth)

EXPERIMENTAL

Care coordination using mHealth technology enhancements

Other: Mobile Health (mHealth)

No mHealth

ACTIVE COMPARATOR

Care coordination without mHealth enhancements

Other: No mHealth

Interventions

Mobile Health (mHealth)OTHER

Participants receive care coordination throughout their chemotherapy treatment using mHealth technology

Also known as: Android-based device, Mobile health, Patient Health Network
Mobile Health (mHealth)
No mHealthOTHER

Participants receive the same evidence-based care coordination without mHealth technology

No mHealth

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Oral chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Comprehensive Cancer Care Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Jill G Joseph, MD, PhD

    University of California, Davis Betty Irene Moore School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2014

First Posted

September 12, 2014

Study Start

December 1, 2013

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

November 16, 2018

Record last verified: 2018-11

Locations

US(1)