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Completed

NCT Number: NCT02238951

Cancer Care Coordination for Chemotherapy Patients

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Comprehensive Cancer Care Center

Sacramento, California, 95817, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile Health (mHealth)

Other

Participants receive care coordination throughout their chemotherapy treatment using mHealth technology

Other names: Android-based device, Mobile health, Patient Health Network

No mHealth

Other

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

Primary outcomes

  1. Change in Patient Health Outcome

    Time frame: Baseline, 3 months, 6 months

    Pain

Secondary outcomes

  1. 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

Other outcomes

  1. Change in Patient Health Outcomes

    Time frame: Baseline, 3 months, 6 months

    • Treatment related symptoms
    • Psychological Distress
    • Quality of Life

  2. Change in Healthcare Outcomes

    Time frame: Baseline, 6 months

    • Processes of care coordination
    • Patient engagement
    • Patient satisfaction

  3. Change in Healthcare Utilization

    Time frame: Baseline, 3 months, 6 months

    • Emergency department visits
    • Unplanned hospitalizations
    • Unplanned clinic visits

  4. 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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Boston University
  • McKesson Foundation

Registry information

Official study title

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

Acronym: 4CP

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 12, 2014
Registry last updated
Nov 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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