Colorectal CancerCATCHNCT01395459
A Sustainable Approach to Increasing Cancer Screening
A study testing IVR only and IVR+PCC in people with Colorectal Cancer and Breast Cancer, run by Harvard School of Public Health (HSPH) at 1 site in United States.
Trial summary
Parent study: A Coordinated Approach to Cancer and Health (CATCH), was designed to compare the efficacy of two intervention arms (described below) intended to increase breast, cervical, and colon cancer screening rates among patients served by community health centers. Read more about this study
- Who is it for?
- Ages 21 to 86 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Breast Cancer, Cervical Cancer
- What is being tested?
- IVR only and IVR+PCC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,675 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Oct 2013
- Phase
- Interventional
- 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 21 to 86 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All age and gender eligible patients, using GLFHC's guidelines, in need of: breast, cervical or colorectal cancer screenings.
Who cannot join
- All GLFHC patients who do are not age or gender eligible for a breast, cervical or colorectal cancer screening.
- Substudy only: Inclusion: age eligible clinic patients who pick up either a gFOBT or FIT kit during the study period. Exclusion: non-age eligible patients who pick up a home test kit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Greater Lawrence Family Health Center (GLFHC)
Lawrence, Massachusetts, 01841
About this study
Parent study:
A Coordinated Approach to Cancer and Health (CATCH), was designed to compare the efficacy of two intervention arms (described below) intended to increase breast, cervical, and colon cancer screening rates among patients served by community health centers. A central focus of CATCH is to evaluate sustainable strategies for maximizing cancer screening rates among populations facing significant cancer disparities.
Read more
CATCH was conducted in partnership with the large health clinic in Massachusetts, which serves a largely Hispanic low income population. Focusing on the use of an Interactive Voice Response (IVR) telephone technology system, the study is examining the extent to which the IVR, when developed in a culturally sensitive and appropriate manner (focus groups will be conducted to inform the intervention), can improve breast, cervical and colon cancer screening rates compared to a control group. Furthermore, we plan to determine if pairing IVR with telephone calls from a prevention care coordinator (PCC) will result in higher screening rates (when compared to the IVR only group). We will determine the cost-effectiveness of IVR alone vs. IVR + PCC.
Substudy:
We conducted a substudy of the parent study, looking at a comparison of return rates of two colorectal cancer screening home test kits: Fecal Occult Bood Tests (gFOBTs) and Fecal Immunochemical Tests (FITs). As well we surveyed people who pick up one of these two types of tests to assess barriers and facilitators of returning the completed kit to the health center for assessment.
Read the detailed description
For the substudy, the study objective was to:
Determine if there is a difference in completion of a home blood stool test kit by type of home test being employed Fecal Occult Blood Test (gFOBT) vs. Fecal Immunochemical Test (FIT), and to determine predictors of test completion.
Substudy methods/design/arms/eligibility:
All patients who picked up a home blood stool test kit during the 6-12 month study recruitment time period were randomized to receive either a gFOBT or FIT kit. Randomization occurred by the month. Medical assistants (MAs) handed out the kits. Participants who picked up a kit (either gFOBT or FIT) were given a study information card that briefly described the study and had a study opt out phone number on it. If patients did not call and opt out, the card let the patient know that he/she would be contacted via telephone to complete a brief survey, for which they were given a small incentive upon completion.
A bilingual member of the study staff telephoned individuals, who had not opted out, who picked up a home blood stool test kit during the study period. Four to six weeks post kit pickup, staff determined if the patient had returned a completed test to the clinic (yes vs. no) by examining the electronic medical record. This information- whether a patient had/had not returned a completed test was used to tailor some questions asked on the survey. Study staff obtained verbal informed consent before survey administration. Participants who cited that time was a burden stopping them from starting the survey were offered an abbreviated version of the survey.
This study was limited to age eligible patients who picked up a home colon cancer screening kit.
- Conditions
- Colorectal Cancer, Breast Cancer, Cervical Cancer
- Being tested
- IVR only, IVR+PCC
- Keywords
- screening, cancer prevention, IVR
- Medical subject headings
- Colorectal Neoplasms, Breast Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVR onlyBehavioural
As noted, patients in this arm receive consistent, but spaced out calls generated by an interactive voice response system reminding them of breast, cervical and colon cancer screenings needed, as applicable.
IVR+PCCBehavioural
Interactive voice response calls followed up by prevention care coordinator calls for those who do not respond to IVR
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Care as usual is given. |
| IVR only | Experimental | The participants in this study arm receive calls from an Interactive Voice Response (IVR) call system, to remind them that they are in need of breast, cervical and colon cancer screening, as applicable. Receives: Behavioral: IVR only |
| IVR+PCC | Experimental | The participants in this study arm receive calls from an Interactive Voice Response (IVR) call system, to remind them that they are in need of breast, cervical and colon cancer screening, as applicable. Furthermore, if remained unscreened, these participants receive person to person follow up telephone calls from a prevention care coordinator (PCC) to address barriers. Receives: Behavioral: IVR+PCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in population level cancer screening level at the health clinics involved.
The primary outcome of interest is improvement of population-level screening and individual outcomes for 3 cancers (breast, cervical, and colorectal)of patients reached during the intervention.
Measured: year 3 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startSep 2008
- Primary completionMar 2011
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13,675 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Karen Emmons, Harvard School of Public Health (HSPH)
- Investigators
- Karen M Emmons, PhD, Principal investigator, Dana-Farber Cancer Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395459
- Sponsor's protocol ID
- 15622
- Other IDs
- R01CA126596
- Acronym
- CATCH
- Status last verified
- Feb 2019
- First submitted
- 9 Jul 2011
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Emmons KM, Cleghorn D, Tellez T, Greaney ML, Sprunck KM, Bastani R, Battaglia T, Michaelson JS, Puleo E. Prevalence and implications of multiple cancer screening needs among Hispanic community health center patients. Cancer Causes Control. 2011 Sep;22(9):1343-9. doi: 10.1007/s10552-011-9807-7. Epub 2011 Jul 5.
PubMed 21728056Greaney ML, De Jesus M, Sprunck-Harrild KM, Tellez T, Bastani R, Battaglia TA, Michaelson JS, Emmons KM. Designing audience-centered interactive voice response messages to promote cancer screenings among low-income Latinas. Prev Chronic Dis. 2014 Mar 13;11:E40. doi: 10.5888/pcd11.130213.
PubMed 24625364
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sustainable Approach to Increasing Cancer Screening
- ClinicalTrials.gov ID
- NCT01395459
- Acronym / sponsor ID
- CATCH / 15622
- Conditions
- Colorectal Cancer, Breast Cancer, Cervical Cancer
- Keywords
- screening, cancer prevention, IVR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13,675 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 15 Jul 2011 (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.
Parent study:
A Coordinated Approach to Cancer and Health (CATCH), was designed to compare the efficacy of two intervention arms (described below) intended to increase breast, cervical, and colon cancer screening rates among patients served by community health centers. A central focus of CATCH is to evaluate sustainable strategies for maximizing cancer screening rates among populations facing significant cancer disparities.
CATCH was conducted in partnership with the large health clinic in Massachusetts, which serves a largely Hispanic low income population. Focusing on the use of an Interactive Voice Response (IVR) telephone technology system, the study is examining the extent to which the IVR, when developed in a culturally sensitive and appropriate manner (focus groups will be conducted to inform the intervention), can improve breast, cervical and colon cancer screening rates compared to a control group. Furthermore, we plan to determine if pairing IVR with telephone calls from a prevention care coordinator (PCC) will result in higher screening rates (when compared to the IVR only group). We will determine the cost-effectiveness of IVR alone vs. IVR + PCC.
Substudy:
We conducted a substudy of the parent study, looking at a comparison of return rates of two colorectal cancer screening home test kits: Fecal Occult Bood Tests (gFOBTs) and Fecal Immunochemical Tests (FITs). As well we surveyed people who pick up one of these two types of tests to assess barriers and facilitators of returning the completed kit to the health center for assessment.
Detailed description
For the substudy, the study objective was to:
Determine if there is a difference in completion of a home blood stool test kit by type of home test being employed Fecal Occult Blood Test (gFOBT) vs. Fecal Immunochemical Test (FIT), and to determine predictors of test completion.
Substudy methods/design/arms/eligibility:
All patients who picked up a home blood stool test kit during the 6-12 month study recruitment time period were randomized to receive either a gFOBT or FIT kit. Randomization occurred by the month. Medical assistants (MAs) handed out the kits. Participants who picked up a kit (either gFOBT or FIT) were given a study information card that briefly described the study and had a study opt out phone number on it. If patients did not call and opt out, the card let the patient know that he/she would be contacted via telephone to complete a brief survey, for which they were given a small incentive upon completion.
A bilingual member of the study staff telephoned individuals, who had not opted out, who picked up a home blood stool test kit during the study period. Four to six weeks post kit pickup, staff determined if the patient had returned a completed test to the clinic (yes vs. no) by examining the electronic medical record. This information- whether a patient had/had not returned a completed test was used to tailor some questions asked on the survey. Study staff obtained verbal informed consent before survey administration. Participants who cited that time was a burden stopping them from starting the survey were offered an abbreviated version of the survey.
This study was limited to age eligible patients who picked up a home colon cancer screening kit.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Care as usual is given. |
| IVR only | Experimental | Behavioral: IVR onlyThe participants in this study arm receive calls from an Interactive Voice Response (IVR) call system, to remind them that they are in need of breast, cervical and colon cancer screening, as applicable. |
| IVR+PCC | Experimental | Behavioral: IVR+PCCThe participants in this study arm receive calls from an Interactive Voice Response (IVR) call system, to remind them that they are in need of breast, cervical and colon cancer screening, as applicable. Furthermore, if remained unscreened, these participants receive person to person follow up telephone calls from a prevention care coordinator (PCC) to address barriers. |
Who may qualify
- Ages
- 21 to 86 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All age and gender eligible patients, using GLFHC's guidelines, in need of: breast, cervical or colorectal cancer screenings.
Key exclusion criteria (2 listed)
- All GLFHC patients who do are not age or gender eligible for a breast, cervical or colorectal cancer screening.
- Substudy only: Inclusion: age eligible clinic patients who pick up either a gFOBT or FIT kit during the study period. Exclusion: non-age eligible patients who pick up a home test kit.
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 |
|---|---|---|
| IVR onlyAs noted, patients in this arm receive consistent, but spaced out calls generated by an interactive voice response system reminding them of breast, cervical and colon cancer screenings needed, as applicable. | Behavioural | IVR only |
| IVR+PCCInteractive voice response calls followed up by prevention care coordinator calls for those who do not respond to IVR | Behavioural | IVR+PCC |
Primary outcome
Change in population level cancer screening level at the health clinics involved.
Time frame: year 3 of the study
The primary outcome of interest is improvement of population-level screening and individual outcomes for 3 cancers (breast, cervical, and colorectal)of patients reached during the intervention.
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 20 Feb 2019.
- Background: PubMed 21728056Emmons KM, Cleghorn D, Tellez T, Greaney ML, Sprunck KM, Bastani R, Battaglia T, Michaelson JS, Puleo E. Prevalence and implications of multiple cancer screening needs among Hispanic community health center patients. Cancer Causes Control. 2011 Sep;22(9):1343-9. doi: 10.1007/s10552-011-9807-7. Epub 2011 Jul 5.
- Background: PubMed 24625364Greaney ML, De Jesus M, Sprunck-Harrild KM, Tellez T, Bastani R, Battaglia TA, Michaelson JS, Emmons KM. Designing audience-centered interactive voice response messages to promote cancer screenings among low-income Latinas. Prev Chronic Dis. 2014 Mar 13;11:E40. doi: 10.5888/pcd11.130213.
- Individual participant dataSharing planned: No
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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.
Karen M Emmons, PhD principal investigator
Dana-Farber Cancer Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVR only and IVR+PCC in people with Colorectal Cancer and Breast Cancer, run by Harvard School of Public Health (HSPH) 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 2 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 20 Feb 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 population level cancer screening level at the health clinics involved. (time frame: year 3 of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01395459, which also lists 2 linked publications.
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 20 Feb 2019.