- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01591187
The Feasibility of Text Messaging to Assess Secondhand Smoke Exposure Among Youngsters With Cancer or Sickle Cell Disease
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Tennessee
-
Memphis, Tennessee, United States, 38105
- St. Jude Children's Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Investigators
- Principal Investigator: James Klosky, PhD, St. Jude Children's Research Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XPD12-026 SMTEXT
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.
Clinical Trials on Cancer
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
Yale UniversityNational Institute of Nursing Research (NINR); The Glimpse Group IncRecruitingCancer | Adolescent Cancer | Young Adult CancerUnited States
-
University of Michigan Rogel Cancer CenterCompletedCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI); Atrium Health Wake Forest BaptistRecruitingCancer | Adolescent Cancer | Young Adult CancerUnited States
-
Vanderbilt-Ingram Cancer CenterEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
Second Affiliated Hospital of Soochow UniversityNot yet recruitingCancer | Solid Cancer
-
New Mexico Cancer Research AllianceOhio State University Comprehensive Cancer Center; H. Lee Moffitt Cancer Center...RecruitingCancer | Cancer RiskUnited States
-
Children's Hospital of PhiladelphiaCompletedCancer | Childhood CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
UNICANCERRecruitingAdvanced Breast Cancer | Advanced Gastric Cancer | Advanced Urothelial Cancer | Advanced Non Small Cell Lung Cancer (NSCLC)France
Clinical Trials on Text messaging
-
University of Colorado, DenverNational Institute of Mental Health (NIMH)CompletedHIV InfectionsUnited States
-
University of UtahEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedCOVID-19United States
-
University of Mississippi Medical CenterNot yet recruitingTobacco Cessation
-
University of RochesterCompleted
-
University of MichiganCompletedStroke | Hypertension
-
University of Nebraska LincolnThe Methodist Hospital Research InstituteCompletedDiabetes Mellitus, Type 2United States
-
China National Center for Cardiovascular DiseasesCompleted
-
University of MichiganCompletedStroke | HypertensionUnited States
-
The Miriam HospitalCompletedHIV | Adherence | RetentionUnited States