Integrating Cancer Control Referrals and Navigators Into United Way 211 Missouri

NCT ID: NCT01027741

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4762 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2011-12-31

Brief Summary

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.

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Phone Referral

Participants receive phone referral to cancer control and prevention services.

Group Type: EXPERIMENTAL

Phone Referral

Intervention Type: BEHAVIORAL

Participants receive phone referral to cancer control and prevention services.

Tailored Cancer Communication

Participants will receive phone referral to cancer control and prevention services as well as tailored materials in the mail.

Group Type: EXPERIMENTAL

Phone Referral

Intervention Type: BEHAVIORAL

Participants receive phone referral to cancer control and prevention services.

Tailored Cancer Communication

Intervention Type: BEHAVIORAL

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.

Cancer Control Navigator

Participants will receive phone referral to cancer control and prevention services as well as a personal cancer control navigator.

Group Type: EXPERIMENTAL

Phone Referral

Intervention Type: BEHAVIORAL

Participants receive phone referral to cancer control and prevention services.

Cancer Control Navigator

Intervention Type: BEHAVIORAL

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.

Control

Participants receive only recommendation to talk to health care professional.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Phone Referral

Participants receive phone referral to cancer control and prevention services.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United Way Missouri

UNKNOWN

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew W Kreuter, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University in St. Louis

St Louis, Missouri, United States

Countries

United States

Other Identifiers

000708

Identifier Type: -

Identifier Source: org_study_id