CancerNCT01804621
RCT to Examine the Effects of Scanning
A study testing Health Newsletter in people with Cancer and Breast Cancer, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of the study is to implement a randomized control trial testing effects of information scanning on cancer prevention and screening behaviors in a population sample of 50-70 year olds. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Breast Cancer, Colorectal Cancer
- What is being tested?
- Health Newsletter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,824 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jun 2011
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- US adults, male or female, between 50 and 70 years of age.
Who cannot join
- Potential subjects will be excluded if they are not between the ages of 50 and 70
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: An RCT to Examine the Effects of Scanning; a Major Step on the Path Towards Population Intervention
The purpose of the study is to implement a randomized control trial testing effects of information scanning on cancer prevention and screening behaviors in a population sample of 50-70 year olds. Participants will receive one of five versions of an e-newsletter once/month for 12 months and will be asked to complete baseline, mid-point, and end-of-project surveys.
- Conditions
- Cancer, Breast Cancer, Colorectal Cancer
- Being tested
- Health Newsletter
- Keywords
- Exercise, Nutrition, Mammography, Colorectal screening
- Medical subject headings
- Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health NewsletterBehavioural
Participants received a health newsletter with articles about general health articles, as well as targeted health articles (differs by condition).
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Participant received health newsletter with targeted articles about exercise behavior. Receives: Behavioral: Health Newsletter |
| Fruit & Vegetable | Experimental | Participant received health newsletter with targeted articles about fruit \& vegetable consumption. Receives: Behavioral: Health Newsletter |
| Colorectal Cancer Screening | Experimental | Participant received health newsletter with targeted articles about colorectal cancer screening. Receives: Behavioral: Health Newsletter |
| Mammography | Experimental | Participant received health newsletter with targeted articles about mammography screening. Receives: Behavioral: Health Newsletter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Behavior
The Godin Scale was used to assess weekly exercise frequency and intensity
Measured: 12 months
Fruit & Vegetable Consumption
Total daily servings of reported fruits and vegetables (maximum of 10) were calculated using a composite measure that summed separate responses for fruits and vegetables.
Measured: 12 months
Mammography Screening Behavior
We used responses to two questions to create a dichotomous measure of whether or not female respondents (all aged 50 to 70) received a mammogram in the past year.
Measured: 12 months
Colorectal cancer screening
A measure of up-to-date colorectal cancer screening status was assessed using individuals' self-reports of recency of colonoscopy (within 10 years), sigmoidoscopy (within five years), and/or fecal occult blood test (FOBT) within one year.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startApr 2010
- Primary completionMay 2011
- Study completionJun 2011
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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15,824 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert Hornik, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804621
- Sponsor's protocol ID
- 811285
- Other IDs
- 3P20CA095856-07S1
- Status last verified
- Dec 2012
- First submitted
- 25 Feb 2013
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An RCT to Examine the Effects of Scanning; a Major Step on the Path Towards Population Intervention
- ClinicalTrials.gov ID
- NCT01804621
- Acronym / sponsor ID
- 811285
- Conditions
- Cancer, Breast Cancer, Colorectal Cancer
- Keywords
- Exercise, Nutrition, Mammography, Colorectal screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15,824 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 5 Mar 2013 (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 purpose of the study is to implement a randomized control trial testing effects of information scanning on cancer prevention and screening behaviors in a population sample of 50-70 year olds. Participants will receive one of five versions of an e-newsletter once/month for 12 months and will be asked to complete baseline, mid-point, and end-of-project surveys.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Health NewsletterParticipant received health newsletter with targeted articles about exercise behavior. |
| Fruit & Vegetable | Experimental | Behavioral: Health NewsletterParticipant received health newsletter with targeted articles about fruit \& vegetable consumption. |
| Colorectal Cancer Screening | Experimental | Behavioral: Health NewsletterParticipant received health newsletter with targeted articles about colorectal cancer screening. |
| Mammography | Experimental | Behavioral: Health NewsletterParticipant received health newsletter with targeted articles about mammography screening. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- US adults, male or female, between 50 and 70 years of age.
Key exclusion criteria (1 listed)
- Potential subjects will be excluded if they are not between the ages of 50 and 70
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 |
|---|---|---|
| Health NewsletterParticipants received a health newsletter with articles about general health articles, as well as targeted health articles (differs by condition). | Behavioural | Colorectal Cancer Screening, Exercise, Fruit & Vegetable, Mammography |
Primary outcome
Exercise Behavior
Time frame: 12 months
The Godin Scale was used to assess weekly exercise frequency and intensity
Fruit & Vegetable Consumption
Time frame: 12 months
Total daily servings of reported fruits and vegetables (maximum of 10) were calculated using a composite measure that summed separate responses for fruits and vegetables.
Mammography Screening Behavior
Time frame: 12 months
We used responses to two questions to create a dichotomous measure of whether or not female respondents (all aged 50 to 70) received a mammogram in the past year.
Colorectal cancer screening
Time frame: 12 months
A measure of up-to-date colorectal cancer screening status was assessed using individuals' self-reports of recency of colonoscopy (within 10 years), sigmoidoscopy (within five years), and/or fecal occult blood test (FOBT) within one year.
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 5 Mar 2013.
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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.
Robert Hornik, 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 Health Newsletter in people with Cancer and Breast Cancer, 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 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 5 Mar 2013. 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?
Exercise Behavior (time frame: 12 months). The study lists 4 primary outcomes in all. 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 5 Mar 2013.