NCT03594006

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 18, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2018

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

February 25, 2018

Last Update Submit

October 7, 2020

Conditions

Keywords

Active Therapy

Outcome Measures

Primary Outcomes (1)

  • Assessing focus group initial perceptions of the care coordination instrument (CCI) as measured by the participants' Likert scale responses to the instruments' questionnaire items.

    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 Outcomes (1)

  • Assessing patient perceptions of care coordination as measured by the care coordination instrument (CCI).

    12 months

Study Arms (1)

Cancer patients on active therapy

OTHER
Behavioral: CCI; cancer care coordination instrument

Interventions

Designed to assess cancer patients' perceptions of care coordination

Cancer patients on active therapy

Eligibility Criteria

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Location

Related Publications (1)

  • Okado I, Cassel K, Pagano I, Holcombe RF. Development and psychometric evaluation of a questionnaire to measure cancer patients' perception of care coordination. BMC Health Serv Res. 2020 Jan 21;20(1):52. doi: 10.1186/s12913-020-4905-4.

    PMID: 31964391BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2018

First Posted

July 20, 2018

Study Start

April 18, 2018

Primary Completion

August 15, 2018

Study Completion

August 15, 2018

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations