CancerNCT01299883
West Philadelphia Consortium Randomized Control Trial
A study testing Integrated vs Non-integrated Risk Education in people with Cancer and Cardiovascular Disease (CVD), run by University of Pennsylvania at 1 site in United States.
Trial summary
The investigators will evaluate the effects of an integrated risk counseling program on behavioral and psychological outcomes in African American men and women in a randomized trial that is implemented and evaluated collaboratively through the West Philadelphia Consortium to Address Disparities. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Cardiovascular Disease (CVD)
- What is being tested?
- Integrated vs Non-integrated Risk Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 543 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Apr 2017
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American
- Age 18-75
- Resident of Philadelphia
Who cannot join
- Previous or current cancer diagnosis
- Previous or current diagnosis of a CVD
- Cognitive disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Center for Community Based Research and Health Disparities
Philadelphia, Pennsylvania, 19104
About this study
Official title: West Philadelphia Consortium to Address Disparities
The investigators will evaluate the effects of an integrated risk counseling program on behavioral and psychological outcomes in African American men and women in a randomized trial that is implemented and evaluated collaboratively through the West Philadelphia Consortium to Address Disparities. The specific aims of this research are as follows:
- To evaluate the effects of integrated versus disease specific counseling on risk exposure behaviors. The investigators predict that compared to individuals who receive disease specific counseling, those who receive integrated counseling will report greater intake of fruits and vegetables and increased rates of physical activity.
- To evaluate effects of integrated versus disease specific counseling on psychological outcomes. The investigators predict that compared to individuals who receive disease specific counseling, those who receive integrated counseling will report greater risk comprehension related to cancer and cardiovascular disease and will be more motivated to make behavioral changes.
- To identify the mechanisms through which integrated risk counseling leads to behavioral change. The investigators predict that changes in risk exposure behaviors (e.g., diet and physical activity) will be mediated by increased risk comprehension and self-efficacy for diet and physical activity.
- Conditions
- Cancer, Cardiovascular Disease (CVD)
- Being tested
- Integrated vs Non-integrated Risk Education
- Keywords
- Cancer, CVD, African American, Health Education Intervention, Intervention RCT, Study focus is to examine the influence of health education regarding either CVD or CVD and cancer on health behaviors.
- Medical subject headings
- Neoplasms, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated vs Non-integrated Risk EducationOther
Integrated group receives education about risk factors for both cancer and CVD whereas the non-integrated group receives information about CVD only to assess differences in health behavior outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Cancer and CVD Education | Active comparator | Participants receive education about both cancer and CVD risk factors and their relationship to dietary and physical activity health behaviors. Receives: Other: Integrated vs Non-integrated Risk Education |
| CVD Education | Active comparator | Participants receive education about CVD risk factors and their relationship to dietary and physical activity health behaviors. Receives: Other: Integrated vs Non-integrated Risk Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary and physical activity behaviors
Measured: 12 months
Secondary outcomes (1)
Exposure to program in terms of attendance
Measured: 4 wks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startAug 2008
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 543 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chanita H Halbert, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299883
- Sponsor's protocol ID
- 5R24MDOO1594-06
- Status last verified
- Oct 2017
- First submitted
- 1 Feb 2011
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Halbert CH, Bellamy S, Bowman M, Briggs V, Delmoor E, Purnell J, Rogers R, Weathers B, Kumanyika S. Effects of integrated risk counseling for cancer and cardiovascular disease in African Americans. J Natl Med Assoc. 2010 May;102(5):396-402. doi: 10.1016/s0027-9684(15)30574-5.
PubMed 20533774Halbert CH, Kumanyika S, Bowman M, Bellamy SL, Briggs V, Brown S, Bryant B, Delmoor E, Johnson JC, Purnell J, Rogers R, Weathers B. Participation rates and representativeness of African Americans recruited to a health promotion program. Health Educ Res. 2010 Feb;25(1):6-13. doi: 10.1093/her/cyp057. Epub 2009 Oct 29.
PubMed 19875730Weathers B, Barg FK, Bowman M, Briggs V, Delmoor E, Kumanyika S, Johnson JC, Purnell J, Rogers R, Halbert CH. Using a mixed-methods approach to identify health concerns in an African American community. Am J Public Health. 2011 Nov;101(11):2087-92. doi: 10.2105/AJPH.2010.191775. Epub 2011 Feb 17.
PubMed 21330592Halbert CH, Bellamy S, Briggs V, Delmoor E, Purnell J, Rogers R, Weathers B, Johnson JC. A comparative effectiveness education trial for lifestyle health behavior change in African Americans. Health Educ Res. 2017 Jun 1;32(3):207-218. doi: 10.1093/her/cyx039.
PubMed 28335038
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- West Philadelphia Consortium to Address Disparities
- ClinicalTrials.gov ID
- NCT01299883
- Acronym / sponsor ID
- 5R24MDOO1594-06
- Conditions
- Cancer, Cardiovascular Disease (CVD)
- Keywords
- Cancer, CVD, African American, Health Education Intervention, Intervention RCT, Study focus is to examine the influence of health education regarding either CVD or CVD and cancer on health behaviors.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 543 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 18 Feb 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.
The investigators will evaluate the effects of an integrated risk counseling program on behavioral and psychological outcomes in African American men and women in a randomized trial that is implemented and evaluated collaboratively through the West Philadelphia Consortium to Address Disparities. The specific aims of this research are as follows:
- To evaluate the effects of integrated versus disease specific counseling on risk exposure behaviors. The investigators predict that compared to individuals who receive disease specific counseling, those who receive integrated counseling will report greater intake of fruits and vegetables and increased rates of physical activity.
- To evaluate effects of integrated versus disease specific counseling on psychological outcomes. The investigators predict that compared to individuals who receive disease specific counseling, those who receive integrated counseling will report greater risk comprehension related to cancer and cardiovascular disease and will be more motivated to make behavioral changes.
- To identify the mechanisms through which integrated risk counseling leads to behavioral change. The investigators predict that changes in risk exposure behaviors (e.g., diet and physical activity) will be mediated by increased risk comprehension and self-efficacy for diet and physical activity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer and CVD Education | Active comparator | Other: Integrated vs Non-integrated Risk EducationParticipants receive education about both cancer and CVD risk factors and their relationship to dietary and physical activity health behaviors. |
| CVD Education | Active comparator | Other: Integrated vs Non-integrated Risk EducationParticipants receive education about CVD risk factors and their relationship to dietary and physical activity health behaviors. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- African American
- Age 18-75
- Resident of Philadelphia
Key exclusion criteria (3 listed)
- Previous or current cancer diagnosis
- Previous or current diagnosis of a CVD
- Cognitive disorder
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 |
|---|---|---|
| Integrated vs Non-integrated Risk EducationIntegrated group receives education about risk factors for both cancer and CVD whereas the non-integrated group receives information about CVD only to assess differences in health behavior outcomes. | Other | CVD Education, Cancer and CVD Education |
Primary outcome
Dietary and physical activity behaviors
Time frame: 12 months
1 secondary outcome
Exposure to program in terms of attendance
Time frame: 4 wks.
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 11 Oct 2017.
- Results publication: PubMed 20533774Halbert CH, Bellamy S, Bowman M, Briggs V, Delmoor E, Purnell J, Rogers R, Weathers B, Kumanyika S. Effects of integrated risk counseling for cancer and cardiovascular disease in African Americans. J Natl Med Assoc. 2010 May;102(5):396-402. doi: 10.1016/s0027-9684(15)30574-5.
- Results publication: PubMed 19875730Halbert CH, Kumanyika S, Bowman M, Bellamy SL, Briggs V, Brown S, Bryant B, Delmoor E, Johnson JC, Purnell J, Rogers R, Weathers B. Participation rates and representativeness of African Americans recruited to a health promotion program. Health Educ Res. 2010 Feb;25(1):6-13. doi: 10.1093/her/cyp057. Epub 2009 Oct 29.
- Results publication: PubMed 21330592Weathers B, Barg FK, Bowman M, Briggs V, Delmoor E, Kumanyika S, Johnson JC, Purnell J, Rogers R, Halbert CH. Using a mixed-methods approach to identify health concerns in an African American community. Am J Public Health. 2011 Nov;101(11):2087-92. doi: 10.2105/AJPH.2010.191775. Epub 2011 Feb 17.
- Derived from this study: PubMed 28335038Halbert CH, Bellamy S, Briggs V, Delmoor E, Purnell J, Rogers R, Weathers B, Johnson JC. A comparative effectiveness education trial for lifestyle health behavior change in African Americans. Health Educ Res. 2017 Jun 1;32(3):207-218. doi: 10.1093/her/cyx039.
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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.
Chanita H Halbert, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated vs Non-integrated Risk Education in people with Cancer and Cardiovascular Disease (CVD), run by University of Pennsylvania 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 3 inclusion and 3 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 11 Oct 2017. 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?
Dietary and physical activity behaviors (time frame: 12 months). 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 NCT01299883, which also lists 4 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 11 Oct 2017.