Validation of an Oncology-specific Instrument to Measure Care Coordination

October 7, 2020 updated by: University of Hawaii

University of Hawai'i Cancer Center Cancer Care Delivery Research: Validation of an Oncology-specific Instrument to Measure Care Coordination

The overarching goal of the project is to use a mixed-methods research design to assess the validity of a new instrument developed to assess cancer patients' perceptions of care coordination across varied care settings.

Study Overview

Status

Completed

Conditions

Detailed Description

This proposed cancer care delivery research project aims to validate a new instrument (CCI; cancer care coordination instrument) designed to assess cancer patients' perceptions of care coordination. Care coordination (CC) is important for all patients, and it is especially important for cancer patients as they have complex episodes of care, multi-disciplinary interventions, prolonged duration of care, and an overall high symptom burden. Further, CC is critical for cancer patients due to several transition points between stages of care (diagnosis, treatment, survivorship, and end of life), varied settings of care (inpatient, ambulatory), and multiple physicians (medical, surgical, radiation oncologists) and other healthcare providers (e.g., oncology nurses, primary care physicians, physicians/nurses' assistants) providing care.

A CCI validated in ethnically/racially diverse samples can be utilized to identify potential targets for intervention and improvement in CC for specific populations and to reduce or eliminate the disparities in cancer health outcomes. Validation of the CCI under this proposal will have widespread applicability to oncology care across varied practice environments and will form a foundation for the creation of similar tools for other chronic and complex conditions.

Study Type

Interventional

Enrollment (Actual)

68

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

    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • University of Hawaii Cancer 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:

  • Active therapy for cancer, defined as a minimum of three exams or therapy visits over a preceding three-month period.
  • Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

-

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cancer patients on active therapy
Designed to assess cancer patients' perceptions of care coordination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing focus group initial perceptions of the care coordination instrument (CCI) as measured by the participants' Likert scale responses to the instruments' questionnaire items.
Time Frame: 12 months

We will assess focus group initial perceptions of the care coordination instrument (CCI) as measured by the participants' Likert scale responses to the instruments' questionnaire items. These 27 survey items are used to assess three domains of care coordination. These domains include patient/physician communications, operations and navigation.

Additionally, the taped narratives and comments of participants provided during the focus group discussions are used to identify and analyze sources of response error in the questionnaire by identifying the cognitive processes respondents use to answer the survey questions. Specifically, whether subjects understand the survey items as intended by the research team.

12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing patient perceptions of care coordination as measured by the care coordination instrument (CCI).
Time Frame: 12 months

Secondary outcome measures are cancer patients' perceptions of CC as measured by the CCI. The current proposed CCI contains 27 multiple-choice questions and measures cancer patients' perceptions of four areas of coordination (patient-physician; between health providers; during inpatient-to-ambulatory care transitions; during transitions across different phases of care) that cover three critical domains of CC (Communication, Operational, Navigation).

Reporting of study results will follow guidelines for qualitative research outlined in the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement and Standard for reporting qualitative research (O'Brien, 2014). The criteria for interviews and focus groups, COREQ, will be followed (Tong et al., 2007). Reported data will include characteristics of the research team and details outlining the theoretical framework, participant selection, setting of the research, and procedures for data collection.

12 months

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

April 18, 2018

Primary Completion (Actual)

August 15, 2018

Study Completion (Actual)

August 15, 2018

Study Registration Dates

First Submitted

February 25, 2018

First Submitted That Met QC Criteria

July 10, 2018

First Posted (Actual)

July 20, 2018

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Holcombe-2018-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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