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

2015年3月4日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

観察的

入学 (実際)

88

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Tennessee
      • Memphis、Tennessee、アメリカ、38105
        • St. Jude Children's Research Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Cancer
Parents of children with cancer will complete a questionnaire.
他の：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.
他の：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.
他の：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Proportion of parents willing to participate in tobacco trials
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

St. Jude Children's Research Hospital

捜査官

  • 主任研究者：James Klosky, PhD、St. Jude Children's Research Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2012年9月1日

一次修了 (実際)

2014年7月1日

研究の完了 (実際)

2014年7月1日

試験登録日

最初に提出

2012年8月22日

QC基準を満たした最初の提出物

2012年8月24日

最初の投稿 (見積もり)

2012年8月27日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年3月5日

QC基準を満たした最後の更新が送信されました

2015年3月4日

最終確認日

2015年3月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • XPD12-110 SMOBAN

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

Questionnaireの臨床試験

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スポンサーと協力者

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条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

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