Integrating Cancer Control Referrals and Navigators Into United Way 211 Missouri

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Washington University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
United Way Missouri
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01027741
First received: December 4, 2009
Last updated: September 24, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Cancer
Behavioral: Phone Referral
Behavioral: Tailored Cancer Communication
Behavioral: Cancer Control Navigator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Integrating Cancer Control Referrals and Navigators Into United Way 211 Missouri

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Use of cancer screening and preventive services [ Time Frame: 0ne and four months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Resolution of a caller's original problem [ Time Frame: One month post-intervention ] [ Designated as safety issue: No ]
  • Degree of unmet basic needs [ Time Frame: One and four months post-intervention ] [ Designated as safety issue: No ]
  • Sense of coherence [ Time Frame: One and four months post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 9696
Study Start Date: December 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phone Referral
Participants receive phone referral to cancer control and prevention services.
Behavioral: Phone Referral
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.
Behavioral: Phone Referral
Participants receive phone referral to cancer control and prevention services.
Behavioral: Tailored Cancer Communication
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.
Behavioral: Phone Referral
Participants receive phone referral to cancer control and prevention services.
Behavioral: Cancer Control Navigator
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027741

Contacts
Contact: Nicole M Caito, MPH, MS, RD 314-935-3706 ncaito@gwbmail.wustl.edu

Locations
United States, Missouri
Washington University in St. Louis Recruiting
St. Louis, Missouri, United States, 63112
Contact: Nicole M Caito, MPH, MS, RD    314-935-3706    ncaito@gwbmail.wustl.edu   
Principal Investigator: Matthew W Kreuter, PhD, MPH         
Sponsors and Collaborators
Washington University School of Medicine
United Way Missouri
Investigators
Principal Investigator: Matthew W Kreuter, PhD, MPH Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Matthew W. Kreuter, PhD, MPH, Washington University
ClinicalTrials.gov Identifier: NCT01027741     History of Changes
Other Study ID Numbers: 000708
Study First Received: December 4, 2009
Last Updated: September 24, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 22, 2014