OncologyNCT03594006
Validation of an Oncology-specific Instrument to Measure Care Coordination
A study testing CCI; cancer care coordination instrument in people with Oncology, run by University of Hawaii at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology
- What is being tested?
- CCI; cancer care coordination instrument
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2018to 15 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
About this study
Official title: 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.
Read the 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.
- Conditions
- Oncology
- Being tested
- CCI; cancer care coordination instrument
- Keywords
- Active Therapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCI; cancer care coordination instrumentBehavioural
Designed to assess cancer patients' perceptions of care coordination
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients on active therapy | Other | Not described Receives: Behavioral: CCI; cancer care coordination instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
Assessing patient perceptions of care coordination as measured by the care coordination instrument (CCI).
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start18 Apr 2018
- Primary completion15 Aug 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594006
- Sponsor's protocol ID
- Holcombe-2018-1
- Status last verified
- Oct 2020
- First submitted
- 25 Feb 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31964391
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Hawai'i Cancer Center Cancer Care Delivery Research: Validation of an Oncology-specific Instrument to Measure Care Coordination
- ClinicalTrials.gov ID
- NCT03594006
- Acronym / sponsor ID
- Holcombe-2018-1
- Conditions
- Oncology
- Keywords
- Active Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients on active therapy | Other | Behavioral: CCI; cancer care coordination instrument |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCI; cancer care coordination instrumentDesigned to assess cancer patients' perceptions of care coordination | Behavioural | Cancer patients on active therapy |
Primary outcome
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.
1 secondary outcome
Assessing patient perceptions of care coordination as measured by the care coordination instrument (CCI).
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 31964391Okado 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CCI; cancer care coordination instrument in people with Oncology, run by University of Hawaii at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03594006, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.