CancerNCT00766766
Reduction of Environmental Tobacco Smoke (ETS) Exposure In Pediatric Cancer Patients
A study testing Health Risk and Behavioral Skills Coaching Sessions, Telephone Coaching Sessions and Physician Feedback Letter in people with Cancer, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
SMOKN5 is aimed at studying ways to reduce environmental tobacco smoke (ETS) for children who are being treated for cancer. The study includes St. Jude parents whose child lives with at least one adult smoker who exposes the child to ETS, also called "secondhand smoke." We are comparing two groups of parents to see… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Cancer
- What is being tested?
- Health Risk and Behavioral Skills Coaching Sessions, Telephone Coaching Sessions and Physician Feedback Letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Jun 2010
- Phase
- Interventional
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient Characteristics
- SJCRH patient with primary diagnosis of any type of cancer.
- ≤17 years of age at the time of enrollment.
- At least one month from diagnosis and in active treatment at the time of enrollment.
- Does not currently use tobacco (defined as abstinence from tobacco during the 30 days preceding the screening assessment as based on patient, 10-17 years of age,and/or parent report).
- Lives with at least one cigarette smoking adult (must be parent or family member/relative) who smokes in their presence (i.e. in the home/hotel, in the same room, in the car, etc) by parent report. Smoking adults will be defined as those who have smoked cigarettes in the past 30 days, per parent report.
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- Patient, 10-17 years of age, reads and speaks English.
- Parent/Step-Parent/Legal Guardian Characteristics:
- Reads and speaks English.
- Informed consent by institutional guidelines.
Who cannot join
- Patient Characteristics
- Patients with relapse or recurrence of disease within the past month or those with progressive disease.
- Patients in medical crisis as determined by consultation with the child's primary care physician.
- Patients with poor prognosis high-risk malignancies not likely to survive 12 months from diagnosis as documented by child's primary care physician.
- On bone marrow transplant service.
- Parent/Step-Parent/Legal Guardian Characteristics:
- Patient's social worker or primary care physician will be consulted prior to parents being approached for enrollment to ensure that the parent is not currently in crisis or distress or have another disabling condition that would preclude participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
SMOKN5 is aimed at studying ways to reduce environmental tobacco smoke (ETS) for children who are being treated for cancer. The study includes St. Jude parents whose child lives with at least one adult smoker who exposes the child to ETS, also called "secondhand smoke." We are comparing two groups of parents to see which group results in lower ETS exposure levels for the child being treated with cancer. The first group will receive the standard information and advice usually given to parents about secondhand smoke. The second group will take part in a new program designed to reduce ETS. The primary objective of the study is to determine the efficacy of an environmental tobacco smoke intervention compared to the standard care control condition, as measured by parent report. Parents in each group answer questions about ETS exposure. We also collect urine samples from the child at specific time points throughout the study. The urine is tested to measure the amount of cotinine, a metabolite of nicotine. Measuring cotinine tells us how much nicotine from tobacco smoke the child has been exposed to. Children who are at least 10 years of age or older will also be asked to complete a set of questions pertaining to their tobacco use history and ETS exposure from others. This will occur at the same five time points in which the parent completes his/her portion. The study will last about 12 months for each participating family. Parents who take part in the study may learn how to lower their child's exposure to ETS, and this may, in turn, lower the child's chances of having ETS-related health problems.
Read the detailed description
160 St. Jude families with a cancer patient who meets eligibility criteria will be enrolled on the study. Eligible St. Jude patients must be 17 years of age or younger at the time of enrollment. They must also be at least one month from initial diagnosis and in active treatment. The patient cannot currently be using tobacco, and he/she must live with at least one cigarette smoking adult who smokes in his/her presence. Both smoking and non-smoking parents are eligible to participate. The inclusion of non-smoking parents reflects the primary objective of the proposed study to reduce ETS exposure in the child's environment. We will evaluate the efficacy of an ETS intervention by using a randomized controlled trial design that incorporates an experimental intervention group (ETS) and a standard care control group (SCC). Parents in the SCC group will receive the standard advice with no additional intervention. The experimental group will participate in a three month, multi-component behavioral program focused on the reduction of the cancer patient's ETS exposure. The program will consist of three bi-weekly face-to-face coaching sessions followed by three bi-weekly telephone coaching sessions that will occur within the first three months following enrollment onto the study. Although telephone counseling sessions will be offered for parents who are not available in person, the face-to-face sessions are encouraged as much as possible. Parents in this group will receive physician feedback letters acknowledging their participation and progress at the start and end of the coaching phase, as well as, a follow-up telephone contact at five months. Self-report and biological measures will be obtained from all families during clinic visits at baseline and at three, six, nine, and twelve months. Reported ETS exposure and the child's urine cotinine levels will serve as the primary dependent variables. Other psychosocial and health outcomes will also be assessed. Children 10 years of age and older will complete a brief ETS exposure questionnaire that asks them to report on exposure in their environment. Parents in each group will be paid $10 for each set of study forms they answer. The total amount that a parent in the control group may receive is $50. Parents in the ETS intervention program will also receive $12.50 for each face-to-face and telephone coaching session in which they take part. The telephone follow-up call occurring at five months will not be compensated. The total amount that a parent in the ETS intervention group may receive is $125. Patients will receive a $10 hospital gift voucher for each urine sample they provide. The total amount that a patient may receive is $50 to $60. At the end of the study, parents who were assigned to the standard advice control group may receive the ETS intervention program without charge, if they so choose. Also, parents in both groups may choose to receive feedback about their child's urine cotinine results at the completion of the study.
- Conditions
- Cancer
- Being tested
- Health Risk and Behavioral Skills Coaching Sessions, Telephone Coaching Sessions, Physician Feedback Letter
- Keywords
- Environmental Tobacco Exposure
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Risk and Behavioral Skills Coaching SessionsBehavioural
Health Risk and Behavioral Skills Coaching Sessions
Telephone Coaching SessionsBehavioural
Telephone Coaching Sessions
Physician Feedback LetterBehavioural
Physician Feedback Letter
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Experimental Intervention Group Receives: Behavioral: Health Risk and Behavioral Skills Coaching Sessions; Behavioral: Telephone Coaching Sessions; Behavioral: Physician Feedback Letter |
| 2 | No intervention | Standard Care Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy of an Environmental Tobacco Smoke (ETS) exposure intervention compared to a Standard Care Control (SCC) condition, as measured by parent report.
Measured: Parent self-reports and patient's urine cotinine levels will be assessed at Baseline, 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startSep 2002
- Primary completionFeb 2010
- Study completionJun 2010
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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sean Phipps, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766766
- Sponsor's protocol ID
- SMOKN5
- Other IDs
- 5R01CA085406
- Status last verified
- Sep 2013
- First submitted
- 3 Oct 2008
- Last updated
- 6 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Environmental Tobacco Smoke (ETS) Exposure In Pediatric Cancer Patients
- ClinicalTrials.gov ID
- NCT00766766
- Acronym / sponsor ID
- SMOKN5
- Conditions
- Cancer
- Keywords
- Environmental Tobacco Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2002
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 6 Oct 2008 (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.
SMOKN5 is aimed at studying ways to reduce environmental tobacco smoke (ETS) for children who are being treated for cancer. The study includes St. Jude parents whose child lives with at least one adult smoker who exposes the child to ETS, also called "secondhand smoke." We are comparing two groups of parents to see which group results in lower ETS exposure levels for the child being treated with cancer. The first group will receive the standard information and advice usually given to parents about secondhand smoke. The second group will take part in a new program designed to reduce ETS. The primary objective of the study is to determine the efficacy of an environmental tobacco smoke intervention compared to the standard care control condition, as measured by parent report. Parents in each group answer questions about ETS exposure. We also collect urine samples from the child at specific time points throughout the study. The urine is tested to measure the amount of cotinine, a metabolite of nicotine. Measuring cotinine tells us how much nicotine from tobacco smoke the child has been exposed to. Children who are at least 10 years of age or older will also be asked to complete a set of questions pertaining to their tobacco use history and ETS exposure from others. This will occur at the same five time points in which the parent completes his/her portion. The study will last about 12 months for each participating family. Parents who take part in the study may learn how to lower their child's exposure to ETS, and this may, in turn, lower the child's chances of having ETS-related health problems.
Detailed description
160 St. Jude families with a cancer patient who meets eligibility criteria will be enrolled on the study. Eligible St. Jude patients must be 17 years of age or younger at the time of enrollment. They must also be at least one month from initial diagnosis and in active treatment. The patient cannot currently be using tobacco, and he/she must live with at least one cigarette smoking adult who smokes in his/her presence. Both smoking and non-smoking parents are eligible to participate. The inclusion of non-smoking parents reflects the primary objective of the proposed study to reduce ETS exposure in the child's environment. We will evaluate the efficacy of an ETS intervention by using a randomized controlled trial design that incorporates an experimental intervention group (ETS) and a standard care control group (SCC). Parents in the SCC group will receive the standard advice with no additional intervention. The experimental group will participate in a three month, multi-component behavioral program focused on the reduction of the cancer patient's ETS exposure. The program will consist of three bi-weekly face-to-face coaching sessions followed by three bi-weekly telephone coaching sessions that will occur within the first three months following enrollment onto the study. Although telephone counseling sessions will be offered for parents who are not available in person, the face-to-face sessions are encouraged as much as possible. Parents in this group will receive physician feedback letters acknowledging their participation and progress at the start and end of the coaching phase, as well as, a follow-up telephone contact at five months. Self-report and biological measures will be obtained from all families during clinic visits at baseline and at three, six, nine, and twelve months. Reported ETS exposure and the child's urine cotinine levels will serve as the primary dependent variables. Other psychosocial and health outcomes will also be assessed. Children 10 years of age and older will complete a brief ETS exposure questionnaire that asks them to report on exposure in their environment. Parents in each group will be paid $10 for each set of study forms they answer. The total amount that a parent in the control group may receive is $50. Parents in the ETS intervention program will also receive $12.50 for each face-to-face and telephone coaching session in which they take part. The telephone follow-up call occurring at five months will not be compensated. The total amount that a parent in the ETS intervention group may receive is $125. Patients will receive a $10 hospital gift voucher for each urine sample they provide. The total amount that a patient may receive is $50 to $60. At the end of the study, parents who were assigned to the standard advice control group may receive the ETS intervention program without charge, if they so choose. Also, parents in both groups may choose to receive feedback about their child's urine cotinine results at the completion of the study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Health Risk and Behavioral Skills Coaching Sessions, Behavioral: Telephone Coaching Sessions, Behavioral: Physician Feedback LetterExperimental Intervention Group |
| 2 | No intervention | –Standard Care Control |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Patient Characteristics
- SJCRH patient with primary diagnosis of any type of cancer.
- ≤17 years of age at the time of enrollment.
- At least one month from diagnosis and in active treatment at the time of enrollment.
- Does not currently use tobacco (defined as abstinence from tobacco during the 30 days preceding the screening assessment as based on patient, 10-17 years of age,and/or parent report).
Key exclusion criteria (7 listed)
- Patient Characteristics
- Patients with relapse or recurrence of disease within the past month or those with progressive disease.
- Patients in medical crisis as determined by consultation with the child's primary care physician.
- Patients with poor prognosis high-risk malignancies not likely to survive 12 months from diagnosis as documented by child's primary care physician.
- On bone marrow transplant service.
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 |
|---|---|---|
| Health Risk and Behavioral Skills Coaching SessionsHealth Risk and Behavioral Skills Coaching Sessions | Behavioural | 1 |
| Telephone Coaching SessionsTelephone Coaching Sessions | Behavioural | 1 |
| Physician Feedback LetterPhysician Feedback Letter | Behavioural | 1 |
Primary outcome
To determine the efficacy of an Environmental Tobacco Smoke (ETS) exposure intervention compared to a Standard Care Control (SCC) condition, as measured by parent report.
Time frame: Parent self-reports and patient's urine cotinine levels will be assessed at Baseline, 3, 6, 9, and 12 months
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 6 Sep 2013.
- St. Jude Children's Research HospitalLink provided by the sponsor.
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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.
Sean Phipps, 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?
A study testing Health Risk and Behavioral Skills Coaching Sessions, Telephone Coaching Sessions and Physician Feedback Letter in people with Cancer, 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 10 inclusion and 7 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 6 Sep 2013. 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?
To determine the efficacy of an Environmental Tobacco Smoke (ETS) exposure intervention compared to a Standard Care Control (SCC) condition, as measured by parent report. (time frame: Parent self-reports and patient's urine cotinine levels will be assessed at Baseline, 3, 6, 9, and 12 months). 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 6 Sep 2013.