SmokingNCT01673243
Parent Willingness to Participate in Tobacco Trials in the Pediatric Clinical Setting
An observational study of Smoking and Cancer, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
Little is known about what factors influence parental decisions to participate or to decline participation in tobacco trials offered in the pediatric clinical setting. Further, it is unclear what proportion of parents treated in our setting would elect to receive formal assistance with quitting smoking or consider… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Smoking, Cancer, Sickle Cell Disease
- What is being tested?
- Questionnaire
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jul 2014
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: For the purposes of this protocol, the term "parent" includes biological parents, step-parents, and legal guardians. The primary study population will consist of parents of St. Jude Children's Research Hospital (SJCRH) patients with a diagnosis of (1) cancer or (2) sickle cell disease (to include genotypes HbSS, HbSC, HbSβ°thal, HbSβ+thal, HbSD, HbSO, Hb S/HPFH, HbSE), or (3) will be a surviving cancer patient.
CHILD INCLUSION CRITERIA:
- SJCRH patient with a diagnosis of cancer or sickle cell disease (to include genotypes HbSS, HbSC, HbSβ°thal, HbSβ+thal, HbSD, HbSO, Hb S/HPFH, HbSE).
- <18 years of age at time of enrollment.
- For patients with cancer, those who are at least one month from diagnosis (to include patients in active treatment section, as well as, survivors in After Completion of Therapy clinic).
CHILD EXCLUSION CRITERIA:
- For patients with cancer, those who have relapsed or had disease recurrence within the past month.
- For patients with cancer, those who have progressive disease.
- In medical crisis, as determined by consultation with the patient's primary care physician.
- On transplant service.
- On inpatient service or expected/scheduled inpatient admission (e.g. hospitalized).
- Experiencing current acute complications of sickle cell disease requiring hospitalization or an acute care visit (e.g., pain crises, acute chest syndrome, acute cerebrovascular events/stroke or active infection/fever, etc.).
PARENT INCLUSION CRITERIA:
- One parent, who is 18 years of age or older, per family of a SJCRH patient who meets criteria.
- Current smoker (defined as having smoked cigarettes in the past 30 days, as based on self-report.)
- Reads and speaks English.
- Has the cognitive capacity to complete study questionnaires.
- Willing and able to provide informed consent according to institutional guidelines.
PARENT EXCLUSION CRITERIA:
- In crisis or distress or have another disabling condition that would preclude participation as determined by consultation with patient's primary care physician and/or social worker prior to study enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: Tobacco Trials at St. Jude: Parent Willingness to Participate Among Families of Children With Cancer, Sickle Cell Disease, or Survivors of Childhood Cancer
Little is known about what factors influence parental decisions to participate or to decline participation in tobacco trials offered in the pediatric clinical setting. Further, it is unclear what proportion of parents treated in our setting would elect to receive formal assistance with quitting smoking or consider alternative approaches that could facilitate eventual smoking cessation. While the recommendation to parents is generally to quit smoking, some may be unwilling or unable to quit and prefer more achievable alternative treatment goals. Some parent smokers may be unlikely to participate in an intervention aimed only at cessation but would be willing to participate in an intervention focused on establishing smoke-free environments for their child. Parents are typically not offered a choice regarding the type of intervention they receive and many interventions are not tailored to their readiness to quit smoking or designed to reach multiple family members in the home who may also smoke. Quitting smoking and establishing smoke-free homes and cars are distinct, yet challenging, goals for parents and families. Both approaches can directly, or indirectly, help parents to quit smoking, reduce the child's exposure to second-hand smoke (SHS), and initiate an important dialogue with families about tobacco control. How parental acceptability of smoking interventions is affected by the context of their child's treatment for cancer or SCD, as well as survivorship, warrants further study.
Read the detailed description
Following a Behavioral Ecological Model (BEM), this study will assess factors that influence parent's willingness to participate in tobacco trials that emphasize cessation or promotion of smoke-free homes/cars while identifying barriers for implementing these strategies. Information will be obtained from questionnaires completed by parents. This information will be used to suggest an appropriate emphasis for intervention, refine our recruitment strategies, design interventions that maximize participation rates and retention, and better direct our resources and future tobacco control efforts for patients and their families.
PRIMARY OBJECTIVE:
- To estimate the proportion of smoking parents of children with cancer, children with sickle cell disease (SCD), and childhood cancer survivors who are willing to participate in tobacco trials offered in the context of their child's medical care.
- Conditions
- Smoking, Cancer, Sickle Cell Disease
- Being tested
- Questionnaire
- Keywords
- Smoking cessation, Household smoking bans, Cancer, Sickle cell disease
- Medical subject headings
- Smoking, Neoplasms, Anemia, Sickle Cell, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire data will be collected one time from parents who enroll on the study during their child's regular clinical visit. We will use a cross-sectional design to estimate the proportion of smoking parents of children with or surviving cancer, or sickle cell disease (SCD) who are willing to participate in tobacco trials, hypothetically offered in the context of their child's medical care. We will also examine the contribution of sociodemographic, environmental, and psychosocial variables, as well as, smoking behaviors as they relate to a parent's willingness to participate in a tobacco-related study.
| Study group | Role | What they receive |
|---|---|---|
| Cancer | Parents of children with cancer will complete a questionnaire. Receives: Other: Questionnaire | |
| Sickle cell disease | Parents of children with sickle cell disease will complete a questionnaire. Receives: Other: Questionnaire | |
| Survivors | Parents of survivors of childhood cancer will complete a questionnaire. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of parents willing to participate in tobacco trials
The proportion of parents who are willing to participate in a tobacco trial will be determined by affirmative responses to at least one of three questions that assess willingness to participate in a research study focused on smoking cessation, adoption of a smoke-free home and car, and/or enforcement and maintenance of a smoke-free home and car.
Measured: Once, at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Klosky, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673243
- Sponsor's protocol ID
- XPD12-110 SMOBAN
- Status last verified
- Mar 2015
- First submitted
- 22 Aug 2012
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Trials at St. Jude: Parent Willingness to Participate Among Families of Children With Cancer, Sickle Cell Disease, or Survivors of Childhood Cancer
- ClinicalTrials.gov ID
- NCT01673243
- Acronym / sponsor ID
- XPD12-110 SMOBAN
- Conditions
- Smoking, Cancer, Sickle Cell Disease
- Keywords
- Smoking cessation, Household smoking bans, Cancer, Sickle cell disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 27 Aug 2012 (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.
Little is known about what factors influence parental decisions to participate or to decline participation in tobacco trials offered in the pediatric clinical setting. Further, it is unclear what proportion of parents treated in our setting would elect to receive formal assistance with quitting smoking or consider alternative approaches that could facilitate eventual smoking cessation. While the recommendation to parents is generally to quit smoking, some may be unwilling or unable to quit and prefer more achievable alternative treatment goals. Some parent smokers may be unlikely to participate in an intervention aimed only at cessation but would be willing to participate in an intervention focused on establishing smoke-free environments for their child. Parents are typically not offered a choice regarding the type of intervention they receive and many interventions are not tailored to their readiness to quit smoking or designed to reach multiple family members in the home who may also smoke. Quitting smoking and establishing smoke-free homes and cars are distinct, yet challenging, goals for parents and families. Both approaches can directly, or indirectly, help parents to quit smoking, reduce the child's exposure to second-hand smoke (SHS), and initiate an important dialogue with families about tobacco control. How parental acceptability of smoking interventions is affected by the context of their child's treatment for cancer or SCD, as well as survivorship, warrants further study.
Detailed description
Following a Behavioral Ecological Model (BEM), this study will assess factors that influence parent's willingness to participate in tobacco trials that emphasize cessation or promotion of smoke-free homes/cars while identifying barriers for implementing these strategies. Information will be obtained from questionnaires completed by parents. This information will be used to suggest an appropriate emphasis for intervention, refine our recruitment strategies, design interventions that maximize participation rates and retention, and better direct our resources and future tobacco control efforts for patients and their families.
PRIMARY OBJECTIVE:
- To estimate the proportion of smoking parents of children with cancer, children with sickle cell disease (SCD), and childhood cancer survivors who are willing to participate in tobacco trials offered in the context of their child's medical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cancer | – | Other: QuestionnaireParents of children with cancer will complete a questionnaire. |
| Sickle cell disease | – | Other: QuestionnaireParents of children with sickle cell disease will complete a questionnaire. |
| Survivors | – | Other: QuestionnaireParents of survivors of childhood cancer will complete a questionnaire. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- For the purposes of this protocol, the term "parent" includes biological parents, step-parents, and legal guardians. The primary study population will consist of parents of St. Jude Children's Research Hospital (SJCRH) patients with a diagnosis of (1) cancer or (2) sickle cell disease (to include genotypes HbSS, HbSC, HbSβ°thal, HbSβ+thal, HbSD, HbSO, Hb S/HPFH, HbSE), or (3) will be a surviving cancer patient.
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 |
|---|---|---|
| QuestionnaireQuestionnaire data will be collected one time from parents who enroll on the study during their child's regular clinical visit. We will use a cross-sectional design to estimate the proportion of smoking parents of children with or surviving cancer, or sickle cell disease (SCD) who are willing to participate in tobacco trials, hypothetically offered in the context of their child's medical care. We will also examine the contribution of sociodemographic, environmental, and psychosocial variables, as well as, smoking behaviors as they relate to a parent's willingness to participate in a tobacco-related study. | Other | Cancer, Sickle cell disease, Survivors |
Primary outcome
Proportion of parents willing to participate in tobacco trials
Time frame: Once, at enrollment
The proportion of parents who are willing to participate in a tobacco trial will be determined by affirmative responses to at least one of three questions that assess willingness to participate in a research study focused on smoking cessation, adoption of a smoke-free home and car, and/or enforcement and maintenance of a smoke-free home and car.
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 2015.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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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.
James Klosky, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking and Cancer, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2015. 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?
Proportion of parents willing to participate in tobacco trials (time frame: Once, at enrollment). 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 2015.