NCT01591187

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 5, 2015

Status Verified

March 1, 2015

Enrollment Period

2.1 years

First QC Date

May 1, 2012

Last Update Submit

March 4, 2015

Conditions

Keywords

Text messagingSecondhand smoke exposure

Outcome Measures

Primary Outcomes (1)

  • Rate of participation and compliance by disease group

    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 Outcomes (1)

  • Parent reports of child SHSe; attitudinal, behavioral, and other socio-environmental variables.

    at end of 90-day period

Study Arms (2)

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 messagingOther: QuestionnaireOther: Interviews

Interventions

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.

Sickle Cell Disease

Child and parent questionnaire data about attitudes, behavioral practices to control SHSe, and other socio-environmental factors will be obtained.

Sickle Cell Disease

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.

Sickle Cell Disease

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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).
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

MeSH Terms

Conditions

NeoplasmsAnemia, Sickle Cell

Interventions

Surveys and QuestionnairesInterviews as Topic

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • James Klosky, PhD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2012

First Posted

May 3, 2012

Study Start

May 1, 2012

Primary Completion

June 1, 2014

Study Completion

November 1, 2014

Last Updated

March 5, 2015

Record last verified: 2015-03

Locations