NCT02906592

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2017

Completed
Last Updated

January 11, 2018

Status Verified

April 1, 2017

Enrollment Period

9 months

First QC Date

September 15, 2016

Last Update Submit

January 9, 2018

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in referral patterns

    Comparison of historical and post GOA service referral patterns

    retrospective data from 1/1/2013-7/7/2016

  • Time to complete the brief GOA

    6 months

  • Number of referrals completed

    6 months

  • Number of patients who needed help completing the brief GOA

    6 months

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scotland Cancer Treatment Center

Laurinburg, North Carolina, 28352, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Leah Zullig, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2016

First Posted

September 20, 2016

Study Start

January 1, 2017

Primary Completion

September 29, 2017

Study Completion

September 29, 2017

Last Updated

January 11, 2018

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations