CancerNCT01591187
The Feasibility of Text Messaging to Assess Secondhand Smoke Exposure Among Youngsters With Cancer or Sickle Cell Disease
An observational study of Cancer and Sickle Cell Disease, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Cancer, Sickle Cell Disease
- What is being tested?
- Text messaging, Questionnaire and Interviews
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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).
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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).
Read the 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).
- Conditions
- Cancer, Sickle Cell Disease
- Being tested
- Text messaging, Questionnaire, Interviews
- Keywords
- Text messaging, Secondhand smoke exposure
- Medical subject headings
- Neoplasms, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text messagingOther
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.
QuestionnaireOther
Child and parent questionnaire data about attitudes, behavioral practices to control SHSe, and other socio-environmental factors will be obtained.
InterviewsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cancer | Participants with a diagnosis of cancer. | |
| Sickle Cell Disease | Participants with a diagnosis of sickle cell disease.
Interventions: Text messaging, Questionnaire, Interviews Receives: Other: Text messaging; Other: Questionnaire; Other: Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at end of 7-day period
Secondary outcomes (1)
Parent reports of child SHSe; attitudinal, behavioral, and other socio-environmental variables.
Measured: at end of 90-day period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego State University, University of South Florida
- Responsible party
- Sponsor
- Investigators
- James Klosky, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591187
- Sponsor's protocol ID
- XPD12-026 SMTEXT
- Status last verified
- Mar 2015
- First submitted
- 1 May 2012
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Text Messaging to Assess Secondhand Smoke Exposure Among Youngsters With Cancer or Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT01591187
- Acronym / sponsor ID
- XPD12-026 SMTEXT
- Conditions
- Cancer, Sickle Cell Disease
- Keywords
- Text messaging, Secondhand smoke exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- San Diego State University, University of South Florida
- Study start
- May 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 3 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer | – | –Participants with a diagnosis of cancer. |
| Sickle Cell Disease | – | Other: Text messaging, Other: Questionnaire, Other: InterviewsParticipants with a diagnosis of sickle cell disease. Interventions: Text messaging, Questionnaire, Interviews |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (14 listed)
- Child Participant:
- Parent Participant:
Key exclusion criteria (9 listed)
- Child Participant:
- Parent participant:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text messagingParticipants 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 | Sickle Cell Disease |
| QuestionnaireChild and parent questionnaire data about attitudes, behavioral practices to control SHSe, and other socio-environmental factors will be obtained. | Other | Sickle Cell Disease |
| InterviewsIndividual 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. | Other | Sickle Cell Disease |
Primary outcome
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.
1 secondary outcome
Parent reports of child SHSe; attitudinal, behavioral, and other socio-environmental variables.
Time frame: at end of 90-day period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Klosky, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Sickle Cell Disease, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of participation and compliance by disease group (time frame: at end of 7-day period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.