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Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Cancer Patients

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT01434342
First received: September 13, 2011
Last updated: May 8, 2017
Last verified: May 2017
Results First Received: May 8, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Other
Conditions: Lung Cancer
Tobacco Use Disorder
Breast Cancer
Colorectal Cancer
Prostate Cancer
Intervention: Drug: Nicotine Replacement Patch

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants are recruited from NCI CCOP sites

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I - Quitline

Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills.

Nicotine Replacement Patch: Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, & 24 we

Arm II - Usual Care Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute’s “Clearing the Air” smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.

Participant Flow:   Overall Study
    Arm I - Quitline   Arm II - Usual Care
STARTED   98   48 
COMPLETED   50   31 
NOT COMPLETED   48   17 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants

Reporting Groups
  Description
Arm I - Quitline

Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills.

Nicotine Replacement Patch: Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, & 24 we

Arm II Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute’s “Clearing the Air” smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
Total Total of all reporting groups

Baseline Measures
   Arm I - Quitline   Arm II   Total 
Overall Participants Analyzed 
[Units: Participants]
 98   48   146 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      69  70.4%      35  72.9%      104  71.2% 
>=65 years      29  29.6%      13  27.1%      42  28.8% 
Age 
[Units: Years]
Median (Full Range)
 57 
 (22 to 75) 
 58 
 (26 to 86) 
 57 
 (22 to 86) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      73  74.5%      36  75.0%      109  74.7% 
Male      25  25.5%      12  25.0%      37  25.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      1   1.0%      0   0.0%      1   0.7% 
Not Hispanic or Latino      96  98.0%      48 100.0%      144  98.6% 
Unknown or Not Reported      1   1.0%      0   0.0%      1   0.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      2   2.0%      0   0.0%      2   1.4% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      19  19.4%      8  16.7%      27  18.5% 
White      77  78.6%      40  83.3%      117  80.1% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   98   48   146 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Feasibility of a Smoking Cessation Intervention Among Cancer Patients   [ Time Frame: 24 Weeks ]

2.  Primary:   Adherence   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Doug Case
Organization: Wake Forest NCORP Research Base
phone: (336) 716-1048
e-mail: dcase@wakehealth.edu



Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01434342     History of Changes
Other Study ID Numbers: REBACCCWFU 99211
U10CA081851 ( U.S. NIH Grant/Contract )
Study First Received: September 13, 2011
Results First Received: May 8, 2017
Last Updated: May 8, 2017