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

March 4, 2015 updated by: St. Jude Children's Research Hospital

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).

Study Overview

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).

Study Type

Observational

Enrollment (Actual)

77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer
Participants with a diagnosis of cancer.
Sickle Cell Disease

Participants with a diagnosis of sickle cell disease.

Interventions: Text messaging, Questionnaire, Interviews

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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of participation and compliance by disease group
Time Frame: at end of 7-day period
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.
at end of 7-day period

Secondary Outcome Measures

Outcome Measure
Time Frame
Parent reports of child SHSe; attitudinal, behavioral, and other socio-environmental variables.
Time Frame: at end of 90-day period
at end of 90-day period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

May 1, 2012

First Submitted That Met QC Criteria

May 2, 2012

First Posted (Estimate)

May 3, 2012

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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