CancerNCT02973022
A Community Based Approach to Reducing Rural Cancer Disparities, Aim 2
An observational study of Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- CC&S
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2016to 17 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Wisconsin resident
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53715
About this study
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.
- Conditions
- Cancer
- Being tested
- CC&S
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC&SOther
Also called Cancer Clear & Simple
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 weeks
Secondary outcomes (1)
Change in cancer knowledge
Change in cancer knowledge measured before the educational session to after the session and duration of that knowledge as measured from right after the session to six months later.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study start7 Oct 2016
- Primary completion17 Sep 2018
- Study completion17 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Elizabeth Jacobs, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973022
- Sponsor's protocol ID
- UW16048
- Other IDs
- 2016-0941, A534253, SMPH\MEDICINE\GEN INT MD, NCI-2019-06442
- Status last verified
- Feb 2019
- First submitted
- 21 Nov 2016
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community Based Approach to Reducing Rural Cancer Disparities, Aim 2
- ClinicalTrials.gov ID
- NCT02973022
- Acronym / sponsor ID
- UW16048
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), American Cancer Society, Inc.
- Study start
- 7 Oct 2016 (actual)
- Primary completion
- 17 Sep 2018 (actual)
- Study completion
- 17 Sep 2018 (actual)
- First posted
- 25 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Community CC&S Group | – | Other: CC&SOnce 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. |
| 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 | – | Other: CC&SOnce 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. |
| 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Wisconsin resident
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC&SAlso: Cancer Clear & SimpleThree 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. | Other | ACEC CC&S Group, Community CC&S Group |
Primary outcome
Change in behavioral intent
Time frame: Up to 3 weeks
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.
1 secondary outcome
Change in cancer knowledge
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- UW Carbone Cancer Center Home PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Jacobs principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in behavioral intent (time frame: Up to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.