NCT01027741

Brief Summary

The proposed study will:

  1. 1.estimate the prevalence of need for cancer screening and prevention in a population of 211 callers;
  2. 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. 3.determine how intensive an intervention is needed to bring about these changes; and
  4. 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.
  5. 5.differ significantly by study group as follows: N \> T \> P \> CONTROL;
  6. 6.vary significantly across study groups based on the intervention dose callers receive; and
  7. 7.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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,762

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

2 years

First QC Date

December 4, 2009

Last Update Submit

May 3, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Use of cancer screening and preventive services

    0ne and four months post-intervention

Secondary Outcomes (3)

  • Resolution of a caller's original problem

    One month post-intervention

  • Degree of unmet basic needs

    One and four months post-intervention

  • Sense of coherence

    One and four months post-intervention

Study Arms (4)

Phone Referral

EXPERIMENTAL

Participants receive phone referral to cancer control and prevention services.

Behavioral: Phone Referral

Tailored Cancer Communication

EXPERIMENTAL

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

Behavioral: Phone ReferralBehavioral: Tailored Cancer Communication

Cancer Control Navigator

EXPERIMENTAL

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

Behavioral: Phone ReferralBehavioral: Cancer Control Navigator

Control

NO INTERVENTION

Participants receive only recommendation to talk to health care professional.

Interventions

Phone ReferralBEHAVIORAL

Participants receive phone referral to cancer control and prevention services.

Cancer Control NavigatorPhone ReferralTailored 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.

Tailored Cancer Communication

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.

Cancer Control Navigator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • calling on behalf of client or other person

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63112, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Matthew W Kreuter, PhD, MPH

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2009

First Posted

December 9, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 11, 2018

Record last verified: 2018-05

Locations