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

4 maart 2015 bijgewerkt door: St. Jude Children's Research Hospital

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

88

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Tennessee
      • Memphis, Tennessee, Verenigde Staten, 38105
        • St. Jude Children's Research Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Cancer
Parents of children with cancer will complete a questionnaire.
Ander: Questionnaire
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.
Sickle cell disease
Parents of children with sickle cell disease will complete a questionnaire.
Ander: Questionnaire
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.
Survivors
Parents of survivors of childhood cancer will complete a questionnaire.
Ander: Questionnaire
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of parents willing to participate in tobacco trials
Tijdsspanne: 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.
Once, at enrollment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

St. Jude Children's Research Hospital

Onderzoekers

  • Hoofdonderzoeker: James Klosky, PhD, St. Jude Children's Research Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2012

Primaire voltooiing (Werkelijk)

1 juli 2014

Studie voltooiing (Werkelijk)

1 juli 2014

Studieregistratiedata

Eerst ingediend

22 augustus 2012

Eerst ingediend dat voldeed aan de QC-criteria

24 augustus 2012

Eerst geplaatst (Schatting)

27 augustus 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

5 maart 2015

Laatste update ingediend die voldeed aan QC-criteria

4 maart 2015

Laatst geverifieerd

1 maart 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • XPD12-110 SMOBAN

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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