Clinical trial NCT01027741: Integrating Cancer Control Referrals and Navigators Into United Way 211 Missouri
Official title: Integrating Cancer Control Referrals and Navigators Into United Way 211 Missouri
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: United Way Missouri
First posted: 2009-12-09
Enrollment: 4762
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Use of cancer screening and preventive services
timeFrame: 0ne and four months post-intervention
Secondary outcomes:
measure: Resolution of a caller's original problem
timeFrame: One month post-intervention
measure: Degree of unmet basic needs
timeFrame: One and four months post-intervention
measure: Sense of coherence
timeFrame: One and four months post-intervention
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Matthew W Kreuter, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: