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Smoking CessationNCT01871506

Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial

A study testing Intensive Counseling (IC) in people with Smoking Cessation, run by Massachusetts General Hospital at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There are currently over 11 million cancer survivors in the U.S. and survival rates are increasing. Unfortunately, 10-30% of cancer patients are current smokers at the time of diagnosis, and many of these patients have elevated socioeconomic, medical, and psychosocial vulnerabilities. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoking Cessation
What is being tested?
Intensive Counseling (IC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
303 participants
Where
3 sitesUnited States
Study dates
Sep 2013to May 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Adult men and women may participate in this study if he/she meet the following requirements:
  • Current, new* patient at one of our three participating study sites: Massachusetts General Hospital (MGH) Cancer Center, Memorial Sloan Kettering Cancer Center (MSKCC), or Dana-Farber Cancer Institute (DFCI);
  • Currently with suspected or newly diagnosed cancer (thoracic, breast, genitourinary, gastrointestinal, head and neck, gynecologic, lymphoma, melanoma);
  • Has smoked a cigarette, even a puff, in the past 30 days;
  • Is willing to consider trying to quit smoking using counseling and/or smoking cessation medication;
  • Is English or Spanish speaking (MGH); English speaking (MSK; DFCI);
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  • Has regular telephone access.
  • [Patients will be considered "new" and eligible under the following conditions:
  • if they are attending approximately one of their first 4 visits or are within approximately 3 months of the initial visit date with their primary oncologist at the Massachusetts General Hospital (MGH) Cancer Center, Memorial Sloan Kettering Cancer Center (MSKCC), or Dana-Farber Cancer Institute (DFCI) for suspected or recently diagnosed cancer;
  • if they come to the MGH, MSKCC, or DFCI for a second opinion, the patient opts to receive their cancer treatment at any of these institutions;
  • if they have a past cancer diagnosis, they are currently faced with a local and distant recurrence of tumors;
  • if they have been treated previously for other types of cancer, they are currently faced with a new form of cancer.]

Who cannot join

  • In an effort to be as inclusive as possible, a patient will be excluded only if he/she:
  • Is NOT currently receiving or has no intentions to receive care at one of three participating cancer treatment centers: Massachusetts General Hospital Cancer Center, Memorial Sloan Kettering Cancer Center, or Dana-Farber Cancer Institute (DFCI);
  • Is currently psychiatrically unstable or otherwise unable to provide informed consent as determined by study investigators or oncology clinician;
  • Is not English or Spanish speaking;
  • Is medically ineligible (as determined by their treating physician);
  • Has insufficient comprehension/literacy.
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  • ADDITIONAL INFORMATION:
  • Participant inclusion/exclusion is not based on use of smoking cessation medication -- he/she may decide not to use any smoking cessation medication and still participate in the study. Patients deemed ineligible will be referred to the state quit line.
  • Patients interested in participating in the study should contact the appropriate contact person, based on whether they are a current patient at the MGH, MSKCC, or DFCI.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

There are currently over 11 million cancer survivors in the U.S. and survival rates are increasing. Unfortunately, 10-30% of cancer patients are current smokers at the time of diagnosis, and many of these patients have elevated socioeconomic, medical, and psychosocial vulnerabilities. Documented risks associated with continued smoking following cancer diagnosis include decreased survival time; increased complications from surgery, radiation, and chemotherapy; and increased risk of second primary tumors. U.S. Department of Health \& Human Services Public Health Service evidence-based tobacco treatment guidelines exist but have not been integrated into the cancer setting. This is a tremendous missed opportunity to address a modifiable risk factor. In recognition of this treatment gap, the National Cancer Institute (NCI) sponsored a conference in 2009 to address how to increase the readiness and capacity for delivery of tobacco treatment in Cancer Centers. The American Society of Clinical Oncology (ASCO) recommends identification, advice, and counseling of all smokers by their second oncology visit as a core quality indicator; however, currently only half of patients report being asked about tobacco use.

Specific Aim: To conduct a randomized controlled comparative effectiveness trial of two strategies to promote smoking cessation in suspected or newly diagnosed cancer patients.

Read more

Study Design: A multi-site randomized controlled comparative effectiveness trial will enroll 295 current smokers with suspected or newly diagnosed melanoma, lymphoma, thoracic, breast, genitourinary, gastrointestinal, head and neck, or gynecologic cancer. Participants will be randomly assigned to receive Intensive Counseling (IC) or "Standard Care" (SC). Both groups will receive an initial motivational counseling session and 3 weekly follow-up counseling sessions with a tobacco treatment counselor, conducted in-person or by telephone. The IC arm has the option to also receive:

  • Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication (Varenicline, bupropion, or combination NRT) at no cost to the participant.
  • Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts).

All participants will complete 1 baseline and 2 follow-up surveys, at 3 and 6 months. Self-reported abstinence will be biochemically confirmed at 3 and 6 months.

Read the detailed description

Specific Aims

Aim 1: To compare the effectiveness of two tobacco treatments that are integrated into cancer care in producing tobacco abstinence at 6 months.

Aim 2: To explore: a) mechanisms through which treatment promotes abstinence; b) subpopulations in which abstinence is promoted; and c) which aspects of treatment promote abstinence.

Aim 3: To compare the incremental cost effectiveness (cost per quit) of two tobacco treatments.

Exploratory Aim: To identify the percentage and associated characteristics of smokers who 1) enroll in tobacco treatment and 2) adhere to tobacco treatment.

Being tested
Standard Care (SC), Intensive Counseling (IC)
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Care (SC)Behavioural

    Also called "Standard of Care" Treatment

    1. Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques.
    2. 3 Weekly Follow-up Counseling Sessions: SC Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment.
    3. Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects.

  • Intensive Counseling (IC)Behavioural

    Also called Intensive Treatment

    The IC model includes all components of the SC as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication.

    1. Extended counseling support: Participants in the IC group will be offered the same initial 4 counseling sessions as the SC group as well as 4 additional proactive biweekly sessions and 3 monthly booster sessions.
    2. Smoking cessation medication: IC participants will be offered a 4-week supply of FDA-approved smoking cessation medication (varenicline, bupropion or nicotine replacement therapy) of their choice, with the option to renew the medication twice for up to 90 days of free medication. Participants are not required to take smoking cessation medication.
Study groups in NCT01871506
Study groupRoleWhat they receive
Standard Care (SC)ExperimentalParticipants randomized to "standard care" (SC) will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice.
Receives: Behavioral: Standard Care (SC)
Intensive Counseling (IC)ExperimentalParticipants randomized to intensive counseling (IC) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IC participants have the option to also receive: * Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts). * Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication [varenicline, bupropion, or combination NRT (patch + lozenge)] at no cost to the participant.
Receives: Behavioral: Intensive Counseling (IC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Biochemically Verified 7-day Point Prevalence Tobacco Abstinence at 6 Months

    Number of participants with 7-day point-prevalence tobacco abstinence at 6-month follow-up, assessed by biochemically confirmed saliva cotinine (<15 ng/ml76, 82) or <10 ppm expired air carbon monoxide (CO) for participants concurrently using NRT

    Measured: 6 months

Secondary outcomes (9)

  1. Number of Participants With Biochemically Verified 7-day Point Prevalence Tobacco Abstinence at 3 Months

    Number of participants with7 -day point-prevalence tobacco abstinence at 3-month follow-up, assessed by biochemically confirmed saliva cotinine (<15 ng/ml76, 82) or <10 ppm expired air carbon monoxide (CO) for participants concurrently using NRT

    Measured: 3 months

  2. Number of Participants With Continuous Tobacco Abstinence

    Number of Participants with Continuous tobacco abstinence (between quit and follow-up) at 3 \& 6 months

    Measured: 3 months to 6 months

  3. Number of Participants With Sustained Tobacco Abstinence

    Number of Participants with Biochemically confirmed repeated point prevalence abstinence at 3 \& 6 months

    Measured: 6 months

  4. Number of Participants With Self-reported 7-day Point Prevalence.

    Number of Participants with Self-reported smoking abstinence of at least 7 days

    Measured: 6 months

  5. The Number of IT Participants Who Used Smoking Cessation Pharmacotherapy

    The number of IT participants who used 1) smoking cessation pharmacotherapy (Y/N dispensed) 2) smoking cessation counseling (Y/N), 3) 1-2 4-week refills, 4) took 1-3 monthly booster sessions.

    Measured: Treatment Initiation to 6 month follow-up

  6. The Number of IT Participants Who Used Smoking Cessation Counseling

    The number of intervention participants who used smoking cessation counseling during the study (Y/N)

    Measured: Treatment Initiation to 6 Month Follow-up

  7. The Number of IT Participants Who Took 1-2 4-week Refills

    The number of intervention participants who took 1-2 4-week refills of smoking cessation medication

    Measured: Treatment Initiation to 6 Month Follow-up

  8. The Number of IT Participants Who Took 1-3 Monthly Booster Sessions

    The number of IT participants who took 1-3 monthly booster sessions of smoking cessation counseling

    Measured: Treatment Initiation to 6 Month Follow-up

  9. Cost-effectiveness

    The cost of the standard of care treatment and the cost of the intensive treatment.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionMay 2018
  4. Study completionMay 2018

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
303 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01871506
Sponsor's protocol ID
2013P001036
Other IDs
1R01CA166147-01A1
Status last verified
Aug 2019
First submitted
4 Jun 2013
Last updated
28 Aug 2019
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Park ER, Perez GK, Regan S, Muzikansky A, Levy DE, Temel JS, Rigotti NA, Pirl WF, Irwin KE, Partridge AH, Cooley ME, Friedman ER, Rabin J, Ponzani C, Hyland KA, Holland S, Borderud S, Sprunck K, Kwon D, Peterson L, Miller-Sobel J, Gonzalez I, Whitlock CW, Malloy L, de Leon-Sanchez S, O'Brien M, Ostroff JS. Effect of Sustained Smoking Cessation Counseling and Provision of Medication vs Shorter-term Counseling and Medication Advice on Smoking Abstinence in Patients Recently Diagnosed With Cancer: A Randomized Clinical Trial. JAMA. 2020 Oct 13;324(14):1406-1418. doi: 10.1001/jama.2020.14581.

    PubMed 33048154

  • Park ER, Ostroff JS, Perez GK, Hyland KA, Rigotti NA, Borderud S, Regan S, Muzikansky A, Friedman ER, Levy DE, Holland S, Eusebio J, Peterson L, Rabin J, Miller-Sobel J, Gonzalez I, Malloy L, O'Brien M, de Leon-Sanchez S, Whitlock CW. Integrating tobacco treatment into cancer care: Study protocol for a randomized controlled comparative effectiveness trial. Contemp Clin Trials. 2016 Sep;50:54-65. doi: 10.1016/j.cct.2016.07.016. Epub 2016 Jul 19.

    PubMed 27444428

Questions about this trial

What is this clinical trial studying?

A study testing Intensive Counseling (IC) in people with Smoking Cessation, run by Massachusetts General Hospital at 3 sites 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 12 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Biochemically Verified 7-day Point Prevalence Tobacco Abstinence at 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01871506, which also lists 2 linked publications.

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 28 Aug 2019.

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