Clinical trial NCT01591187: The Feasibility of Text Messaging to Assess Secondhand Smoke Exposure Among Youngsters With Cancer or Sickle Cell Disease
Official title: The Feasibility of Text Messaging to Assess Secondhand Smoke Exposure Among Youngsters With Cancer or Sickle Cell Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Sickle Cell Disease
Keywords: Text messaging
Secondhand smoke exposure
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: San Diego State University
name: University of South Florida
First posted: 2012-05-03
Enrollment: 77
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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).

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 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.

Primary outcomes:
measure: Rate of participation and compliance by disease group
timeFrame: at end of 7-day period
Secondary outcomes:
measure: Parent reports of child SHSe; attitudinal, behavioral, and other socio-environmental variables.
timeFrame: at end of 90-day period
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: James Klosky, PhD
role: PRINCIPAL_INVESTIGATOR
References: