- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03594006
Validation of an Oncology-specific Instrument to Measure Care Coordination
University of Hawai'i Cancer Center Cancer Care Delivery Research: Validation of an Oncology-specific Instrument to Measure Care Coordination
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96813
- University of Hawaii Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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.