CancerGOALNCT02906592
Using a Geriatric Oncology Assessment to Link With Services
An observational study of Cancer, run by Duke University at 1 site in United States.
Trial summary
The objective of this study is to implement a brief geriatric oncology assessment (GOA) in a community-based oncology clinic, the Scotland Cancer Treatment Center - a clinic within the Duke Cancer Network, located in the rural, low resource Scotland County community of North Carolina. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cancer
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 29 Sep 2017
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Geriatric (60 years or older) patients in a community-based cancer clinic at Scotland Memorial Hospital. They serve a racially diverse (e.g., 35% African American, 10% Native American), elderly (e.g., 65% >65 years), rural, low resource community with over 20% of the population living in poverty.
Who may be able to join
- In order to be included in the project, patients must be:
- Diagnosed for a solid tumor cancer (breast, lung, colon, rectal, colorectal (unspecified), pancreas, esophageal)
- Diagnosis date within 12 months of identification
- Receiving care at Scotland Cancer Treatment Center
- Aged 60 years or older at the time of the visit
- Planned therapy in the medical oncology clinic at the Scotland Cancer Treatment Center
Who cannot join
- Diagnosis of metastatic cancer with <12 months life expectancy
- Planned cancer therapy as surgery only
- Receiving palliative or hospice care services (i.e., proxy for <12 months life expectancy)
- Language (not proficient in English)
- Nursing home/long-term care facility resident
- Active diagnosis of psychosis (has been hospitalized in the last 30 days), schizophrenia, severe intellectual or developmental disabilities, or dementia
- Patient deemed not fit/good candidate for study per provider recommendation
Trial locations and contacts
1 site in 1 country.
United States1 site
Scotland Cancer Treatment Center
Laurinburg, North Carolina, 28352
About this study
Official title: Using a Geriatric Oncology Assessment to Link With Services (GOAL)
The objective of this study is to implement a brief geriatric oncology assessment (GOA) in a community-based oncology clinic, the Scotland Cancer Treatment Center - a clinic within the Duke Cancer Network, located in the rural, low resource Scotland County community of North Carolina. Secondly, the investigators will evaluate the effectiveness of the brief GOA by comparing historical and post-GOA service referral patterns and adherence to planned cancer therapy. For this study, the investigators will prospectively enroll up to 60 patients who have been diagnosed and/or treated for cancer to complete the brief GOA. In addition to these 60 patients, the investigators will also conduct retrospective chart reviews on 120 patients that would be eligible for this study to evaluate past referral patterns. Eligible and consented patients will complete the brief GOA at the Scotland Cancer Treatment Center alongside their normal clinic appointment. The investigators will assess impact on the healthcare system by evaluating referral patterns (i.e., how many, what type of services) using the brief GOA data and EHR data. The study value includes the possibility for recognition and access to additional health care referrals if needed.
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in referral patterns
Comparison of historical and post GOA service referral patterns
Measured: retrospective data from 1/1/2013-7/7/2016
Time to complete the brief GOA
Measured: 6 months
Number of referrals completed
Measured: 6 months
Number of patients who needed help completing the brief GOA
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startJan 2017
- Primary completion29 Sep 2017
- Study completion29 Sep 2017
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 CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Leah Zullig, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906592
- Sponsor's protocol ID
- Pro00073547
- Acronym
- GOAL
- Status last verified
- Apr 2017
- First submitted
- 15 Sep 2016
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zullig LL, Kimmick G, Smith V, Little K, Bosworth HB, Gonzales S, Oakes MM, Shelby RA, Owen L, Altomare IP. Using a geriatric oncology assessment to link with services (GOAL). J Geriatr Oncol. 2019 Jan;10(1):164-168. doi: 10.1016/j.jgo.2018.06.004. Epub 2018 Jun 27.
PubMed 29958815
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Geriatric Oncology Assessment to Link With Services (GOAL)
- ClinicalTrials.gov ID
- NCT02906592
- Acronym / sponsor ID
- GOAL / Pro00073547
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Duke Cancer Institute
- Study start
- Jan 2017
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 20 Sep 2016 (estimated)
- 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 objective of this study is to implement a brief geriatric oncology assessment (GOA) in a community-based oncology clinic, the Scotland Cancer Treatment Center - a clinic within the Duke Cancer Network, located in the rural, low resource Scotland County community of North Carolina. Secondly, the investigators will evaluate the effectiveness of the brief GOA by comparing historical and post-GOA service referral patterns and adherence to planned cancer therapy. For this study, the investigators will prospectively enroll up to 60 patients who have been diagnosed and/or treated for cancer to complete the brief GOA. In addition to these 60 patients, the investigators will also conduct retrospective chart reviews on 120 patients that would be eligible for this study to evaluate past referral patterns. Eligible and consented patients will complete the brief GOA at the Scotland Cancer Treatment Center alongside their normal clinic appointment. The investigators will assess impact on the healthcare system by evaluating referral patterns (i.e., how many, what type of services) using the brief GOA data and EHR data. The study value includes the possibility for recognition and access to additional health care referrals if needed.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Geriatric (60 years or older) patients in a community-based cancer clinic at Scotland Memorial Hospital. They serve a racially diverse (e.g., 35% African American, 10% Native American), elderly (e.g., 65% >65 years), rural, low resource community with over 20% of the population living in poverty.
Key inclusion criteria (6 listed)
- Diagnosed for a solid tumor cancer (breast, lung, colon, rectal, colorectal (unspecified), pancreas, esophageal)
- Diagnosis date within 12 months of identification
- Receiving care at Scotland Cancer Treatment Center
- Aged 60 years or older at the time of the visit
- Planned therapy in the medical oncology clinic at the Scotland Cancer Treatment Center
Key exclusion criteria (7 listed)
- Diagnosis of metastatic cancer with <12 months life expectancy
- Planned cancer therapy as surgery only
- Receiving palliative or hospice care services (i.e., proxy for <12 months life expectancy)
- Language (not proficient in English)
- Nursing home/long-term care facility resident
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in referral patterns
Time frame: retrospective data from 1/1/2013-7/7/2016
Comparison of historical and post GOA service referral patterns
Time to complete the brief GOA
Time frame: 6 months
Number of referrals completed
Time frame: 6 months
Number of patients who needed help completing the brief GOA
Time frame: 6 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 11 Jan 2018.
- Derived from this study: PubMed 29958815Zullig LL, Kimmick G, Smith V, Little K, Bosworth HB, Gonzales S, Oakes MM, Shelby RA, Owen L, Altomare IP. Using a geriatric oncology assessment to link with services (GOAL). J Geriatr Oncol. 2019 Jan;10(1):164-168. doi: 10.1016/j.jgo.2018.06.004. Epub 2018 Jun 27.
- Individual participant dataSharing planned: No
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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.
Leah Zullig, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Duke University 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 6 inclusion and 7 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 11 Jan 2018. 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?
Change in referral patterns (time frame: retrospective data from 1/1/2013-7/7/2016). The study lists 4 primary outcomes in all. 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 NCT02906592, 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 11 Jan 2018.