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


Phase 4
18 Years
N/A
Not Enrolling
Both
Smoking Cessation

Thank you

Trial Information

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


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.


Inclusion Criteria:



A new** [**Patients will be considered "new" if they are attending approximately one of
their first 4 visits 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. Patients who come to the MGH or MSKCC for a second opinion and
opt to receive their cancer treatment at one of these institutions will be considered
eligible. Local and distant recurrence of tumors in patients with past cancer diagnoses
will be considered "new" diagnoses in this study. Patients with a new form of cancer who
have been treated previously for other types of cancer will be considered eligible] adult
patient who has smoked a cigarette, even a puff, in the past week, with suspected or newly
diagnosed thoracic, breast, genitourinary or gastrointestinal cancer will be considered
eligible if he/she:

1. is willing to consider trying to quit smoking using counseling and/or medication

2. is English or Spanish speaking

3. has regular telephone access

Participants may decide not to use any medication.

Exclusion Criteria:

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

1. is currently psychiatrically unstable or otherwise unable to provide informed consent
as determined by study investigators or oncology clinician

2. is not English or Spanish speaking

3. is medically ineligible (as determined by their treating physician)

4. has no intention to receive their cancer care at MGH or MSKCC

Any participant may decide not to use any medication. Patients deemed ineligible will be
referred to the state quit line.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Biochemically verified 7-day point prevalence tobacco abstinence at 6 months

Outcome Description:

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

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Elyse R Park, Ph.D., MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

2013P001036

NCT ID:

NCT01871506

Start Date:

September 2013

Completion Date:

June 2017

Related Keywords:

  • Smoking Cessation
  • Smoking

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Massachusetts General HospitalBoston, Massachusetts  02114-2617