Trial record 4 of 32 for:    "secondhand smoke" | Open Studies

The Feasibility of Text Messaging to Assess Secondhand Smoke Exposure Among Youngsters With Cancer or Sickle Cell Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by St. Jude Children's Research Hospital
Sponsor:
Collaborators:
San Diego State University
University of South Florida
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01591187
First received: May 1, 2012
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

Exposure to secondhand smoke is a leading preventable cause of child morbidity and mortality, and the adverse health consequences of secondhand smoke are magnified among youngsters with cancer and sickle cell disease. Current methods for measuring secondhand smoke exposure (SHSe) rely on retrospective reports over extended time periods that are subject to recall errors and systematic inaccuracies in reporting and often do not include the youngster as the primary informant. These methods may underestimate the extent of cumulative SHSe and are not well suited to capturing exposure over time and across settings where young people frequent. More appealing methods that engage youngsters to better monitor tobacco smoke in their environment are warranted.

The study will examine the feasibility of cell phone texting to obtain measures of secondhand smoke exposure (SHSe) in children treated for cancer or sickle cell disease (SCD).


Condition Intervention
Cancer
Sickle Cell Disease
Other: Text messaging
Other: Questionnaire
Other: Interviews

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Feasibility of Text Messaging to Assess Secondhand Smoke Exposure Among Youngsters With Cancer or Sickle Cell Disease

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Rate of participation and compliance by disease group [ Time Frame: at end of 7-day period ] [ Designated as safety issue: No ]
    Rates of participation on the study, compliance with reporting SHSe, feedback about the technical viability of the texting methods, and satisfaction regarding the texting procedures will be obtained.


Secondary Outcome Measures:
  • Parent reports of child SHSe; attitudinal, behavioral, and other socio-environmental variables. [ Time Frame: at end of 90-day period ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: May 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cancer
Participants with a diagnosis of cancer.
Sickle Cell Disease

Participants with a diagnosis of sickle cell disease.

Interventions: Text messaging, Questionnaire, Interviews

Other: Text messaging
Participants report on the smoking that takes place in their presence for a period of 7 days by responding to daily texted messages sent by the research team to their mobile phones. Parents will also be asked to report on the child's SHSe during the same 7-day period so that child and parent reports can be compared.
Other: Questionnaire
Child and parent questionnaire data about attitudes, behavioral practices to control SHSe, and other socio-environmental factors will be obtained.
Other: Interviews
Individual interviews with youngsters will provide additional qualitative information about the social context and conditions in the child's environment that maintain or contribute to avoidance of exposure.

Detailed Description:

Children participating on this study will be asked to report on the smoking that takes place in their presence for a period of 7 days by responding to daily texted messages sent by the research team to their mobile phones. Rates of participation on the study, compliance with reporting SHSe, and feedback about the technical viability and satisfaction with the texting methods will be obtained. Parents will also be asked to report on the child's SHSe during the same 7-day period so that child and parent reports can be compared. In addition to quantitative child and parent reports of SHSe, child and parent questionnaire data about attitudes, behavioral practices to control SHSe, and other socio-environmental factors will be obtained. Individual interviews with youngsters will provide additional qualitative information about the social context and conditions in the child's environment that maintain or contribute to avoidance of exposure. This information will be collectively used to develop a larger trial that will test a behavioral intervention to reduce SHSe among youngsters with cancer and SCD and require them to monitor their SHSe using text messaging. Measuring SHSe in these vulnerable populations and intervening to reduce their SHSe is critical to protecting their current and long-term health.

As participation rates and compliance may differ among youngsters diagnosed with cancer and sickle cell disease, participants will be stratified by disease group (up to 55 with cancer and up to 55 with SCD).

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

For the purposes of this protocol, the notation of the term "parent" will be used to include biological parents, step-parents, and legal guardians. The primary study population will consist of patients and parents with the characteristics noted under eligibility criteria.

Criteria

Inclusion Criteria:

  • Child Participant:

    • St. Jude Children's Research Hospital (SJCRH) patient with primary diagnosis of any type of cancer or any sickle cell disease genotype (HbSS, HbSC, HbSβ°thal, HbSβ+thal, HbSD, HbSO, Hb S/HPFH, HbSE).
    • 10 to < 18 years of age at the time of enrollment.
    • For cancer patients, at least one month from diagnosis and in active treatment section at the time of enrollment.
    • Lives in a smoking household defined as at least one adult (> 18 years) smoker who resides in the home. Smoking adults will be defined as those who have smoked at least one cigarette in the past 30 days, per parent report.
    • Does not currently use tobacco (defined as abstinence from tobacco during the 30 days preceding the screening assessment as based on patient and/or parent report).
    • Able to demonstrate satisfactory texting skills via mobile phone as determined by study research staff.
    • Cannot have significant cognitive or learning impairment that precludes completion of study measures.
    • Reads and speaks English.
    • Willing and able to provide assent according to institutional guidelines.
  • Parent Participant:

    • Parent of SJCRH patient who meets criteria as stated above.
    • Reads and speaks English.
    • Willing and able to provide informed consent according to institutional guidelines.

Exclusion Criteria:

  • Child Participant:

    • Patients diagnosed with cancer who have relapsed or have recurrence of disease within the past month or those with progressive disease.
    • Patients in medical crisis as determined by consultation with their primary care physician.
    • On bone marrow transplant service.
    • On inpatient service or expected/scheduled inpatient admission (e.g. hospitalized).
    • Acute complications of sickle cell disease requiring hospitalization or an acute care visit including pain crises, acute chest syndrome, acute cerebrovascular events/stroke or active infection/fever.
    • Patient is residing in St. Jude long-term nonsmoking housing facility (e.g. Target House or Ronald McDonald House) during the 7-day texting data collection phase.
  • Parent participant:

    • Cannot be in crisis or distress or have another disabling condition that would preclude participation as determined by review of patient's medical record prior to study enrollment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591187

Contacts
Contact: James Klosky, PhD 866-278-5833 info@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: James Klosky, PhD    866-278-5833    info@stjude.org   
Principal Investigator: James Klosky, PhD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
San Diego State University
University of South Florida
Investigators
Principal Investigator: James Klosky, PhD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01591187     History of Changes
Other Study ID Numbers: XPD12-026 SMTEXT
Study First Received: May 1, 2012
Last Updated: April 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Text messaging
Secondhand smoke exposure

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 20, 2014