- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03247634
Getting Ahead for Cancer Control
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study team hypothesizes that the Getting Ahead program, applied in safety net practices with primary care patients living in poverty, will improve cancer prevention and early detection activities, mediated by a shift in future orientation gained through the program.
This pilot study aims to adapt, apply, and evaluate the established Getting Ahead program in a health care setting and assess its effect on cancer prevention and early detection activities for vulnerable populations. By generating process and outcome data on a novel intervention to help people advance out of poverty, this research will set the stage for larger intervention studies, and also will advance understanding of the mechanisms by which growing a future orientation can improve cancer preventive service delivery among vulnerable populations.
Specifically, this study aims to:
- Implement Getting Ahead among cohorts of patients at a network of safety net practices.
- Assess the paradigm shift in developing a future orientation associated with participation in the Getting Ahead program.
- Evaluate the effect of the Getting Ahead program and its associated paradigm shift on graduates' cancer prevention and early detection activities.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Case Western Reserve University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Interest and willingness to commit to the 8 week Getting Ahead training program that will occur over 16 sessions occurring twice a week
- Willingness to commit to follow-up with his/her primary care provider after completion of the Getting Ahead training program
- Willingness to be randomized to an immediate or delayed (by 8 weeks) start date
- Ability to speak English
Exclusion Criteria:
- There are no exclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Getting Ahead Program
12 staggered cohorts will be given the Getting Ahead program, using the established Getting Ahead in a Just-Gettin'-By World program.
Six practices will be used.
Each participant will come in for 16 session over an eight week period and will be followed up six months post intervention
|
The Getting Ahead program is a unique welldeveloped program that allows carefully guided introspection toward the crafting of tailored solutions aimed at addressing complex social determinants of health among individuals living in vulnerable populations where the achievement of health equity often seems unattainable.
The important lens of health equity is a key component of this proposal and is consistent with the American Cancer Society overarching emphasis on reduction of health disparities and achievement of health equity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in composite score of cancer prevention
Time Frame: From baseline up to 3 years
|
Change in composite score of cancer prevention based on changes in cognition, intention and behavior regarding tobacco reduction, fruit and vegetable consumption, and physical activity; Immunizations for human papillomavirus (HPV) or hepatitis B; Age/sex appropriate use of Pap tests, mammograms, stool tests, endoscopy or imaging studies for colorectal cancer
|
From baseline up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in composite score of progress toward a future orientation
Time Frame: From baseline up to 3 years
|
change in composite scores based on 11 resource areas with a score ranging from 1-5 (total scores ranging from 11-55 with 55 being the most stable score).
The score indicates the level of stability
|
From baseline up to 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Heidi Gullett, MD, Case Comprehensive Cancer Center
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
Other Study ID Numbers
- CASE11Z17
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.
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