Pediatric CancerPhase 2NCT01828502
Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer
A Phase 2 study testing Education and Cotinine Education in people with Pediatric Cancer, run by University of South Florida at 10 sites in United States.
Trial summary
RATIONALE: Providing parent/caregivers of children with cancer with education and evidence of secondhand smoke exposure can protect the child from future exposure to tobacco smoke. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Education and Cotinine Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2013to Jun 2016
- Phase
- Phase 2
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ≥ 2 years and ≤ 12 years at the time of study entry.
- Currently undergoing treatment for cancer at the time of enrollment, at least 28 days post diagnosis.
- The child must reside 5 days a week with a household smoker (defined as a person who smokes greater than 10 cigarettes daily).
- Child must be potty trained.
- Parent/Legal Guardian ≥ 18 years of age.
- Parent/Legal Guardian who accompanies the child to the first visit must accompany the child to all other visits. This person does not need to be the household smoker, but must be willing to educate the smoker on results at the visit and take the education handout home to them.
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- Parent/Legal Guardian must have a working phone to complete the week 5 follow-up phone call.
- Able and willing to sign informed consent/assent.
- Signed HIPAA compliant research authorization.
Who cannot join
- Planned hospitalization within 3 days of any scheduled study visit (due to the urine cotinine measurement representing the previous 48-72 hours of tobacco exposure.
- Inability to perform the initial cotinine test.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Lee Memorial Hospital - The Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
St. Vincent Hospital
Green Bay, Wisconsin, 54301
Nemours Children's Clinic
Jacksonville, Florida, 32207
Columbia University Medical Center
New York, New York, 10032
Nemours Children's Hospital
Orlando, Florida, 32827
Nemours Children's Clinic
Pensacola, Florida, 32504
All Children's Hospital
Saint Petersburgh, Florida, 33701
Tampa General Hospital
Tampa, Florida, 33606
Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
RATIONALE: Providing parent/caregivers of children with cancer with education and evidence of secondhand smoke exposure can protect the child from future exposure to tobacco smoke.
PURPOSE: This randomized study will compare education only to education plus cotinine feedback in decreasing secondhand smoke exposure in pediatric patients with cancer that reside with a household smoker.
Read the detailed description
OBJECTIVES:
The primary objective of this study is to determine if providing urine cotinine feedback to caregivers in conjunction with standard education will be more effective than education alone in reducing patient SHS exposure.
The secondary objectives of this study are:
To determine whether urine cotinine feedback in conjunction with education provided to the caregiver is more effective in changing parental smoking behavior compared to education alone.
As an exploratory measure we will collect history and physical exam data to follow patient's clinical complications during the study to determine if patients with a decrease in SHS exposure also have a decrease in clinical complications.
- Conditions
- Pediatric Cancer
- Being tested
- Education, Cotinine Education
- Keywords
- Cotinine, Secondhand Smoke Exposure (SHSE), Secondhand Smoke (SHS)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Participants in both groups will receive education by the EPA on the danger of exposure to secondhand smoke and how exposure can be prevented.
Cotinine EducationBehavioural
Those randomized to the active intervention will also be provided with education utilizing the cotinine test strip in conjunction with the education from the EPA.
| Study group | Role | What they receive |
|---|---|---|
| Active Intervention | Experimental | Those randomized to the active intervention will receive education about secondhand smoke exposure and feedback using the cotinine test strip. Receives: Behavioral: Education; Behavioral: Cotinine Education |
| Education only | Other | Those randomized to the education only group will receive only the education about secondhand smoke exposure. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urine cotinine level
The primary objective of this study is to determine if providing urine cotinine feedback to caregivers in conjunction with standard education will be more effective than education alone in reducing patient SHS exposure.
Measured: 4 weeks after baseline visit
Secondary outcomes (2)
Change in Self-Reported Smoking Behavior
To determine whether urine cotinine feedback in conjunction with education provided to the caregiver is more effective in changing parental smoking behavior compared to education alone.
Measured: 4 weeks after baseline visit
Number of medical complications
As an exploratory measure we will collect history and physical exam data to follow patient's clinical complications during the study to determine if patients with a decrease in SHS exposure also have a decrease in clinical complications.
Measured: 4 weeks after baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Why it stopped: The study was closed due to poor accrual. No patients were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Marisa Couluris, DO, Study chair, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828502
- Sponsor's protocol ID
- SCUSF 1201
- Status last verified
- Oct 2014
- First submitted
- 28 Mar 2013
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer
- ClinicalTrials.gov ID
- NCT01828502
- Acronym / sponsor ID
- SCUSF 1201
- Conditions
- Pediatric Cancer
- Keywords
- Cotinine, Secondhand Smoke Exposure (SHSE), Secondhand Smoke (SHS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was closed due to poor accrual. No patients were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 10 Apr 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.
RATIONALE: Providing parent/caregivers of children with cancer with education and evidence of secondhand smoke exposure can protect the child from future exposure to tobacco smoke.
PURPOSE: This randomized study will compare education only to education plus cotinine feedback in decreasing secondhand smoke exposure in pediatric patients with cancer that reside with a household smoker.
Detailed description
OBJECTIVES:
The primary objective of this study is to determine if providing urine cotinine feedback to caregivers in conjunction with standard education will be more effective than education alone in reducing patient SHS exposure.
The secondary objectives of this study are:
To determine whether urine cotinine feedback in conjunction with education provided to the caregiver is more effective in changing parental smoking behavior compared to education alone.
As an exploratory measure we will collect history and physical exam data to follow patient's clinical complications during the study to determine if patients with a decrease in SHS exposure also have a decrease in clinical complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Intervention | Experimental | Behavioral: Education, Behavioral: Cotinine EducationThose randomized to the active intervention will receive education about secondhand smoke exposure and feedback using the cotinine test strip. |
| Education only | Other | Behavioral: EducationThose randomized to the education only group will receive only the education about secondhand smoke exposure. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Age ≥ 2 years and ≤ 12 years at the time of study entry.
- Currently undergoing treatment for cancer at the time of enrollment, at least 28 days post diagnosis.
- The child must reside 5 days a week with a household smoker (defined as a person who smokes greater than 10 cigarettes daily).
- Child must be potty trained.
- Parent/Legal Guardian ≥ 18 years of age.
Key exclusion criteria (2 listed)
- Planned hospitalization within 3 days of any scheduled study visit (due to the urine cotinine measurement representing the previous 48-72 hours of tobacco exposure.
- Inability to perform the initial cotinine test.
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 |
|---|---|---|
| EducationParticipants in both groups will receive education by the EPA on the danger of exposure to secondhand smoke and how exposure can be prevented. | Behavioural | Active Intervention, Education only |
| Cotinine EducationThose randomized to the active intervention will also be provided with education utilizing the cotinine test strip in conjunction with the education from the EPA. | Behavioural | Active Intervention |
Primary outcome
Change in urine cotinine level
Time frame: 4 weeks after baseline visit
The primary objective of this study is to determine if providing urine cotinine feedback to caregivers in conjunction with standard education will be more effective than education alone in reducing patient SHS exposure.
2 secondary outcomes
Change in Self-Reported Smoking Behavior
Time frame: 4 weeks after baseline visit
Number of medical complications
Time frame: 4 weeks after baseline visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
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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.
Marisa Couluris, DO study chair
University of South Florida
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Education and Cotinine Education in people with Pediatric Cancer, run by University of South Florida at 10 sites 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 9 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: withdrawn, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 urine cotinine level (time frame: 4 weeks after baseline visit). 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 29 Oct 2014.