- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01027741
Integrating Cancer Control Referrals and Navigators Into United Way 211 Missouri
The proposed study will:
- estimate the prevalence of need for cancer screening and prevention in a population of 211 callers;
- determine whether cancer communication interventions delivered through 211 can increase use of breast, cervical and colon cancer screening, HPV vaccination, smoking cessation and adoption of smoke free home policies;
- determine how intensive an intervention is needed to bring about these changes; and
- determine whether the effectiveness of these interventions is enhanced when callers' basic needs have been addressed. Connecting these systems - 211, clinical and community cancer control programs and navigation services - should benefit disadvantaged Americans. The proposed study will evaluate the effects of this approach to eliminating cancer disparities.
We hypothesize that the proportion of 211 callers who obtain a needed cancer control service will:
- differ significantly by study group as follows: N > T > P > CONTROL;
- vary significantly across study groups based on the intervention dose callers receive; and
- vary significantly across study groups based on whether callers' original need was resolved, the extent of their basic needs, and their perception of life as manageable and predictable (i.e., sense of coherence).
(Dissemination Aim): Determine costs to 211 and effects on quality of service by offering cancer control referrals.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
For Americans living in poverty, cancer prevention and screening is a lower priority than meeting basic needs. When basic needs are addressed, the likelihood of engaging in these preventive behaviors increases. Strategies to eliminate cancer disparities in disadvantaged populations must recognize and address this fundamental challenge. We propose the first-ever cancer communication research partnership with United Way 2-1-1, a telephone information and referral system reaching millions of low-income and minority Americans every year and connecting them to locally available resources that can meet their basic needs. By proactively linking these callers to evidence-based cancer control services available for free in their community, cancer disparities could be reduced.
The proposed study will:
- estimate the prevalence of need for cancer screening and prevention in a population of 211 callers;
- determine whether cancer communication interventions delivered through 211 can increase use of breast, cervical and colon cancer screening, HPV vaccination, smoking cessation and adoption of smoke free home policies;
- determine how intensive an intervention is needed to bring about these changes; and
- determine whether the effectiveness of these interventions is enhanced when callers' basic needs have been addressed. Connecting these systems - 211, clinical and community cancer control programs and navigation services - should benefit disadvantaged Americans. The proposed study will evaluate the effects of this approach to eliminating cancer disparities.
Objectives:
Study group assignment -- By random assignment they will then receive either:
- Tailored Cancer Communication to help them act on the cancer control referral they received;
- A Cancer Control Navigator to help them overcome obstacles to obtaining needed cancer control services;
- Cancer Control Phone Referral Only; or,
- No intervention control
The study aims are to:
- Estimate the prevalence of need for cancer screening and prevention in a population of 211 callers and compare these rates to population data from Missouri and the U.S.
- Evaluate effects of Tailored Cancer Communication (T), Cancer Control Navigation (N), Cancer Control Phone Referral Only (P) on use of cancer control services in a randomized trial among 211 callers.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63112
- Washington University in St. Louis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years of age or older
- caller to 211 who was randomly allocated to one of two study-specific information specialists
- resident of Missouri
- calling for unmet needs for self
Exclusion Criteria:
- calling on behalf of client or other person
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Phone Referral
Participants receive phone referral to cancer control and prevention services.
|
Participants receive phone referral to cancer control and prevention services.
|
|
Experimental: Tailored Cancer Communication
Participants will receive phone referral to cancer control and prevention services as well as tailored materials in the mail.
|
Participants receive phone referral to cancer control and prevention services.
Mailed material with messages tailored to participant's age, gender, race/ethnicity, whether he or she has kids in the home, reason for calling 211, and cancer control need.
|
|
Experimental: Cancer Control Navigator
Participants will receive phone referral to cancer control and prevention services as well as a personal cancer control navigator.
|
Participants receive phone referral to cancer control and prevention services.
A cancer control navigator is assigned to each participant.
This navigator helps the participant make and keep cancer control and prevention appointments, as well as providing resources and guidance to help address participant barriers to use of needed cancer control and prevention services.
Intervention is phone-based.
|
|
No Intervention: Control
Participants receive only recommendation to talk to health care professional.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Use of cancer screening and preventive services
Time Frame: 0ne and four months post-intervention
|
0ne and four months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Resolution of a caller's original problem
Time Frame: One month post-intervention
|
One month post-intervention
|
|
Degree of unmet basic needs
Time Frame: One and four months post-intervention
|
One and four months post-intervention
|
|
Sense of coherence
Time Frame: One and four months post-intervention
|
One and four months post-intervention
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Matthew W Kreuter, PhD, MPH, Washington University School of Medicine
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 (Estimate)
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
- 000708
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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