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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Massachusetts General Hospital
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Elyse Park, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01871506
First received: June 4, 2013
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

There are currently over 11 million cancer survivors in the U.S. and survival rates are increasing. Unfortunately, 10% to 30% of cancer patients are current smokers at the time of cancer 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 care setting. This is a tremendous missed opportunity to address a modifiable risk factor. In recognition of this tobacco 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 cancer 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.

Study Design: A dual-site randomized controlled comparative effectiveness trial will enroll 295 current smokers with suspected or newly diagnosed thoracic, breast, genitourinary, or gastrointestinal cancer. Participants will be randomly assigned to one of two strategies, an Intensive Treatment (IT) or a "Standard of Care" Treatment (ST). Both groups will be offered an initial motivational counseling session, delivered by a trained tobacco counselor, and 3 weekly follow-up counseling sessions that will be provided in-person or by telephone. The IT group has the option to also receive:

  • Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication (varenicline 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 months and 6 months. Self-reported abstinence will be biochemically confirmed at 3 and 6 months.


Condition Intervention Phase
Smoking Cessation
Behavioral: Standard of Care Treatment (ST)
Behavioral: Intensive Treatment (IT)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Biochemically verified 7-day point prevalence tobacco abstinence at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The primary endpoint is 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


Secondary Outcome Measures:
  • Biochemically verified 7-day point prevalence tobacco abstinence at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    7-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

  • Continuous tobacco abstinence [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
    Continuous tobacco abstinence (between quit and follow-up) at 3 & 6 months

  • Sustained tobacco abstinence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Biochemically confirmed repeated point prevalence abstinence at 3 & 6 months

  • Self-reported point prevalence tobacco abstinence [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
  • Significant reduction in cigarette smoking [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
    Self-reported significant reduction (>50% decrease) in cigarettes per day

  • 7-day intentional quit attempt [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
    Self-reported 7-day intentional quit attempt

  • Treatment use and adherence [ Time Frame: Treatment Initiation to 6 month follow-up ] [ Designated as safety issue: No ]
    The proportion of participants who use 1)smoking cessation pharmacotherapy (varenicline or combination nicotine replacement therapy) 2) smoking cessation counseling, 3)duration (days) of medication use 4)number of counseling contacts, and 5)length of counseling calls.


Other Outcome Measures:
  • All-cause hospitalizations [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    All-cause hospitalizations over the 6 months of patient study involvement will be documented and reviewed. Hospitalizations are expected to be high in this vulnerable population of cancer patients.

  • All- cause mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    All-cause deaths over the 6 month patient study involvement will be documented and reviewed.

  • Cost-effectiveness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The incremental cost effectiveness (cost per quit) of the standard of care treatment versus the intensive treatment.


Estimated Enrollment: 295
Study Start Date: September 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard of Care Treatment (ST)
Participants randomized to the "standard of care" treatment (ST) will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice.
Behavioral: Standard of Care Treatment (ST)
  1. Initial counseling session: The initial counseling session will last for 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: ST 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 ST 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 ST subjects.
Experimental: Intensive Treatment (IT)

Participants randomized to the intensive treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the ST arm. IT 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 or combination NRT (patch + lozenge)] at no cost to the participant.
Behavioral: Intensive Treatment (IT)

The IT model includes all components of the ST 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 IT group will be offered the same initial 4 counseling sessions as the ST group as well as 4 additional proactive biweekly sessions and 3 monthly booster sessions.
  2. Smoking cessation medication: IT participant will be offered a 4-week supply of FDA-approved smoking cessation medication (varenicline 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

Adult men and women may participate in this study if he/she meet the following requirements:

  1. Current, new* patient at one of our two participating study sites: Massachusetts General Hospital (MGH) Cancer Center or Memorial Sloan Kettering Cancer Center (MSKCC);
  2. Currently with suspected or newly diagnosed cancer (thoracic, breast, genitourinary, gastrointestinal, or head and neck);
  3. Has smoked a cigarette, even a puff, in the past week;
  4. Is willing to consider trying to quit smoking using counseling and/or smoking cessation medication;
  5. Is English or Spanish speaking;
  6. Has regular telephone access.

[*Patients will be considered "new" and eligible under the following conditions:

  1. if they are attending approximately one of their first 4 visits or are within 3 months of the initial visit date with their primary oncologist at the Massachusetts General Hospital (MGH) Cancer Center or Memorial Sloan Kettering Cancer Center (MSKCC) for suspected or recently diagnosed cancer;
  2. if they come to the MGH or MSKCC for a second opinion, the patient opts to receive their cancer treatment at either of these institutions;
  3. if they have a past cancer diagnosis, they are currently faced with a local and distant recurrence of tumors;
  4. if they have been treated previously for other types of cancer, they are currently faced with a new form of cancer.]

EXCLUSION CRITERIA:

In an effort to be as inclusive as possible, a patient will be excluded only if he/she:

  1. Is NOT currently receiving care at one of two participating cancer treatment centers: Massachusetts General Hospital Cancer Center; or the Memorial Sloan Kettering Cancer Center.
  2. Is currently psychiatrically unstable or otherwise unable to provide informed consent as determined by study investigators or oncology clinician;
  3. Is not English or Spanish speaking;
  4. Is medically ineligible (as determined by their treating physician);

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 either MGH or MSKCC.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01871506

Contacts
Contact: Elyse R. Park, Ph.D., MPH epark@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Elyse R. Park, Ph.D., MPH       epark@partners.org   
Principal Investigator: Elyse R. Park, Ph.D., MPH         
United States, New York
Memorial Sloan-Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
Contact: Jamie S. Ostroff, Ph.D.       ostroffj@MSKCC.ORG   
Principal Investigator: Jamie S. Ostroff, Ph.D.         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Elyse R Park, Ph.D., MPH Massachusetts General Hospital
Principal Investigator: Jamie S. Ostroff, Ph.D. Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: Elyse Park, PhD, Associate Professor of Psychiatry, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01871506     History of Changes
Other Study ID Numbers: 2013P001036, 1R01CA166147-01A1
Study First Received: June 4, 2013
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 28, 2014