CancerNCT02723656
Proactive Care Coordination for Cancer Survivors Who Smoke
A study testing Online Referral NYS Quitline and Tobacco cessation counseling and coordination of cessation medications in people with Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a population-based randomized controlled trial of 600 patients with a diagnosis of cancer in the past 2 years and registry indicating smoking at the time of diagnosis, that will inform critical questions regarding the relative efficacy of care coordination options, the reliability of Electronic Health Record… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Online Referral NYS Quitline and Tobacco cessation counseling and coordination of cessation medications
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 581 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 29 Sep 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICD 9 cancer diagnosis seen at each site in the past two years
- Documentation of current smoking in the cancer registry.
Who cannot join
- Dementia
- Stage IV or Stage IIIB cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Using Cancer Registry Data to Promote Proactive Tobacco Cessation Among Adult Cancer Survivors U48
This is a population-based randomized controlled trial of 600 patients with a diagnosis of cancer in the past 2 years and registry indicating smoking at the time of diagnosis, that will inform critical questions regarding the relative efficacy of care coordination options, the reliability of Electronic Health Record (EHR) tobacco use data, and how patients will react to proactive tobacco related communications. Investigators will compare the reach and efficacy of two proactive approaches to enrolling cancer survivors in tobacco treatment (Arm 1: mailed care coordination vs. Arm 2: telephone care coordination) using a two-arm randomized design at two urban cancer centers, and will explore cancer survivor attitudes and preferences about proactive tobacco treatment.
- Conditions
- Cancer
- Being tested
- Online Referral NYS Quitline, Tobacco cessation counseling and coordination of cessation medications
- Keywords
- smoking, cancer, cancer registry, smoking cessation
- Medical subject headings
- Neoplasms, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Referral NYS QuitlineBehavioural
Care coordinator will make an online referral to the NYS Quitline.
Tobacco cessation counseling and coordination of cessation medicationsBehavioural
Care coordinator will obtain verbal consent to transfer the patient to the NYS Quitline via 3-way call (warm transfer). The care coordinator will also assist the patient in obtaining NRT from a regular care provider, then call the patient every three months for 12 months to assess current smoking and offer to help smokers obtain additional cessation counseling and medications.
| Study group | Role | What they receive |
|---|---|---|
| Proactive mailed care coordination | Active comparator | Not described Receives: Behavioral: Online Referral NYS Quitline |
| Proactive telephone care coordination. | Active comparator | Not described Receives: Behavioral: Tobacco cessation counseling and coordination of cessation medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients in the study's original proactive outreach cohort of N=600 who complete at least one call with the Quitline
Measured: 12 Months
Secondary outcomes (1)
biochemically validated 7-day abstinence
Measured: 6 Months, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion29 Sep 2018
- Study completion29 Sep 2018
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 NYU Langone HealthThe 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 581 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Krebs, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723656
- Sponsor's protocol ID
- 15-01069
- Status last verified
- Dec 2018
- First submitted
- 24 Mar 2016
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Cancer Registry Data to Promote Proactive Tobacco Cessation Among Adult Cancer Survivors U48
- ClinicalTrials.gov ID
- NCT02723656
- Acronym / sponsor ID
- 15-01069
- Conditions
- Cancer
- Keywords
- smoking, cancer, cancer registry, smoking cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 581 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 29 Sep 2018 (actual)
- Study completion
- 29 Sep 2018 (actual)
- First posted
- 30 Mar 2016 (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.
This is a population-based randomized controlled trial of 600 patients with a diagnosis of cancer in the past 2 years and registry indicating smoking at the time of diagnosis, that will inform critical questions regarding the relative efficacy of care coordination options, the reliability of Electronic Health Record (EHR) tobacco use data, and how patients will react to proactive tobacco related communications. Investigators will compare the reach and efficacy of two proactive approaches to enrolling cancer survivors in tobacco treatment (Arm 1: mailed care coordination vs. Arm 2: telephone care coordination) using a two-arm randomized design at two urban cancer centers, and will explore cancer survivor attitudes and preferences about proactive tobacco treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proactive mailed care coordination | Active comparator | Behavioral: Online Referral NYS Quitline |
| Proactive telephone care coordination. | Active comparator | Behavioral: Tobacco cessation counseling and coordination of cessation medications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ICD 9 cancer diagnosis seen at each site in the past two years
- Documentation of current smoking in the cancer registry.
Key exclusion criteria (2 listed)
- Dementia
- Stage IV or Stage IIIB cancer
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 |
|---|---|---|
| Online Referral NYS QuitlineCare coordinator will make an online referral to the NYS Quitline. | Behavioural | Proactive mailed care coordination |
| Tobacco cessation counseling and coordination of cessation medicationsCare coordinator will obtain verbal consent to transfer the patient to the NYS Quitline via 3-way call (warm transfer). The care coordinator will also assist the patient in obtaining NRT from a regular care provider, then call the patient every three months for 12 months to assess current smoking and offer to help smokers obtain additional cessation counseling and medications. | Behavioural | Proactive telephone care coordination. |
Primary outcome
Proportion of patients in the study's original proactive outreach cohort of N=600 who complete at least one call with the Quitline
Time frame: 12 Months
1 secondary outcome
biochemically validated 7-day abstinence
Time frame: 6 Months, 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 11 Dec 2018.
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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.
Paul Krebs, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Referral NYS Quitline and Tobacco cessation counseling and coordination of cessation medications in people with Cancer, run by NYU Langone Health 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 2 inclusion and 2 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 11 Dec 2018. 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?
Proportion of patients in the study's original proactive outreach cohort of N=600 who complete at least one call with the Quitline (time frame: 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 11 Dec 2018.