Clinical trial · Interventional
Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer
NCT01828502CI-TRIAL-00015931withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was closed due to poor accrual. No patients were enrolled.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cotinine Education | Behavioral | — | UNRESOLVED |
| Education | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active Intervention
- description
- Those randomized to the active intervention will receive education about secondhand smoke exposure and feedback using the cotinine test strip.
- interventionNames
- Behavioral: Education
- Behavioral: Cotinine Education
- type
- OTHER
- label
- Education only
- description
- Those randomized to the education only group will receive only the education about secondhand smoke exposure.
- interventionNames
- Behavioral: Education
Primary outcomes (1)
- measure
- Change in urine cotinine level
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.