Integrating Cancer Control Referrals and Navigators Into United Way 211 Missouri

The proposed study will:

  1. estimate the prevalence of need for cancer screening and prevention in a population of 211 callers;
  2. 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;
  3. determine how intensive an intervention is needed to bring about these changes; and
  4. 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:

  1. differ significantly by study group as follows: N > T > P > CONTROL;
  2. vary significantly across study groups based on the intervention dose callers receive; and
  3. 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

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:

  1. estimate the prevalence of need for cancer screening and prevention in a population of 211 callers;
  2. 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;
  3. determine how intensive an intervention is needed to bring about these changes; and
  4. 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:

  1. 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.
  2. 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

Interventional

Enrollment (Actual)

4762

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Missouri
      • Saint Louis, Missouri, United States, 63112
        • Washington University in St. Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Matthew W Kreuter, PhD, MPH, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

December 4, 2009

First Submitted That Met QC Criteria

December 8, 2009

First Posted (Estimate)

December 9, 2009

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

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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