NCT02973022

Brief Summary

The aim of this study is to evaluate the impact of participation in Cancer Clear and Simple (CC\&S) educational sessions on cancer prevention and screening. The researchers will recruit 60 community members: 30 will receive CC\&S training (intervention group) and 30 will not (control group). All 60 will be surveyed about their intent to change their behavior at the beginning of the study and their actual behavior changes and their screening behavior 6 months after enrollment in the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2016

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

October 7, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2018

Completed
Last Updated

December 12, 2019

Status Verified

February 1, 2019

Enrollment Period

1.9 years

First QC Date

November 21, 2016

Last Update Submit

December 11, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in behavioral intent

    All 60 participants (30 intervention, 30 control group) will be surveyed about their intent to change their behavior at the beginning of the study and their actual behavior changes and their cancer screening behavior 6 months after enrollment in the study.

    Up to 3 weeks

Secondary Outcomes (1)

  • Change in cancer knowledge

    Up to 6 months

Study Arms (4)

Community CC&S Group

Once participants are randomized, they will be given survey 1. The intervention group in the community will be exposed to the modified CC\&S educational sessions in a series of 2 one hour and 15 minute sessions on consecutive Monday nights. A free meal will be provided at both educational sessions. Childcare will be provided for community sessions. Once the final educational session is completed, all participants will be given survey 2.

Other: CC&S

Community Control Group

Once participants are randomized, they will be given survey 1. The control group in the community will be exposed to a nutrition education program in a series of 2 one hour and 15 minute sessions on consecutive Monday nights. A free meal will be provided at both educational session. Childcare will be provided for community sessions. Once the final educational session is completed, all participants will be given survey 2.

ACEC CC&S Group

Once participants are randomized, they will be given survey 1. The intervention group at ACEC (Adams-Columbia Electric Company) will be exposed to the modified CC\&S educational sessions in a series of 6 thirty minute sessions before the work day begins over the course of several weeks. The researchers anticipate that two sessions will occur per week and therefore the delivery of the whole intervention will take 3 weeks. A free meal will be provided at all 6 educational sessions. Once the final educational session is completed, all participants will be given survey 2.

Other: CC&S

ACEC Control Group

Once participants are randomized, they will be given survey 1. The control group at ACEC will be exposed to a nutrition education program in a series of 6 thirty minute sessions before the work day begins over the course of several weeks. We anticipate that two sessions will occur per week and therefore the delivery of the whole intervention will take 3 weeks. A free meal will be provided at all 6 educational sessions. Once the final educational session is completed, all participants will be given survey 2.

Interventions

CC&SOTHER

Three educational modules -- Cancer Basics, Cancer Prevention, and Cancer Screening -- intended to increase cancer awareness. The full CC\&S curriculum is currently available at http://chdi.wisc.edu/cancer-clear-simple-curriculum-rural-adaptation.

Also known as: Cancer Clear & Simple
ACEC CC&S GroupCommunity CC&S Group

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Thirty ACEC employees and 30 residents of a rural Wisconsin county. The researchers will work to make sure the sample is representative of the community in regards to age, gender, and employments status.

You may qualify if:

  • Wisconsin resident

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53715, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Elizabeth Jacobs

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2016

First Posted

November 25, 2016

Study Start

October 7, 2016

Primary Completion

September 17, 2018

Study Completion

September 17, 2018

Last Updated

December 12, 2019

Record last verified: 2019-02

Locations