Clinical trial NCT01673243: Parent Willingness to Participate in Tobacco Trials in the Pediatric Clinical Setting
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Cancer
Sickle Cell Disease
Keywords: Smoking cessation
Household smoking bans
Cancer
Sickle cell disease
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2012-08-27
Enrollment: 88
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of parents willing to participate in tobacco trials
timeFrame: Once, at enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: James Klosky, PhD
role: PRINCIPAL_INVESTIGATOR
References: