Parent Willingness to Participate in Tobacco Trials in the Pediatric Clinical Setting

NCT01673243 | Completed

• 1 other identifier: XPD12-110 SMOBAN
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Cancer; Sickle Cell Disease

Keywords

Smoking cessation; Household smoking bans; Cancer; Sickle cell disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Once, at enrollment

Study Arms (3)

Cancer

Parents of children with cancer will complete a questionnaire.

Other: Questionnaire

Sickle cell disease

Parents of children with sickle cell disease will complete a questionnaire.

Other: Questionnaire

Survivors

Parents of survivors of childhood cancer will complete a questionnaire.

Other: Questionnaire

Interventions

Questionnaire OTHER

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.

Cancer; Sickle cell disease; Survivors

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.).
• 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.
• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Smoking; Neoplasms; Anemia, Sickle Cell; Smoking Cessation

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Health Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• James Klosky, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: August 27, 2012
• Study Start: September 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 5, 2015

Record last verified: 2015-03

Locations

US (1)