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NCT01098955 · ClinicalTrials.gov registry record · Early Phase 1
Smoking Cessation Treatment for Head & Neck Cancer Patients
A Early Phase 1 study of Head and Neck Cancer and Smoking Cessation, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Early Phase 1
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT01098955: Active Early Phase 1 study of Head and Neck Cancer and Smoking Cessation, sponsored by M.D. Anderson Cancer Center.
NCT01098955 is a Early Phase 1 study of Head and Neck Cancer and Smoking Cessation that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 51 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01098955, a Early Phase 1 study of Head and Neck Cancer and Smoking Cessation, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
Study Summary
This is Part 1 of a 2-part research study. The goal of this part of the study is to plan and test an investigational type of counseling called Acceptance and Commitment Therapy, for use in patients who have or had head and neck cancer, lung cancer, breast cancer, gastrointestinal cancer, or genitourinary cancer. This part of the study is also designed to train the study counselors how to perform Acceptance and Commitment Therapy. In this part of the study, participants will either receive Acceptance and Commitment Therapy or the standard type of counseling, called Motivational and Behavioral Counseling. This is Part 2 of a 2-part research study. In both parts of the study, participants receive either an investigational type of counseling (Acceptance and Commitment Therapy) or a standard type of counseling (Motivational and Behavioral Counseling). Part 1 was also designed to train the study counselors how to perform Acceptance and Commitment Therapy. The goal of Part 2 is to compare Acceptance and Commitment Therapy against Motivational and Behavioral Counseling. Researchers want to learn which type of counseling may be more effective in helping patients to stop smoking. These types of counseling will be tested in patients who have or had head and neck cancer, lung cancer, breast cancer, gastrointestinal cancer, or genitourinary cancer.
Primary Outcome
Participants will be assessed on a variety of interview, self-report, and biochemical measures at baseline, at key points during treatment (including end of treatment), and at 14-, and 26-weeks after the targeted quit date
Conditions Studied
Interventions
- DRUG Varenicline
- BEHAVIORAL Acceptance and Commitment Therapy
- BEHAVIORAL Motivational and Behavioral Counseling
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2010-03-24 |
| Est. Completion | 2027-09-30 |
| Phase | Early Phase 1 |
What the registry record for NCT01098955 still lists
NCT01098955 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (80% lower).
The record links to 2 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 3 interventions - of which Varenicline is the first listed.
NCT01098955 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01098955 about?
NCT01098955 is a clinical study titled "Smoking Cessation Treatment for Head & Neck Cancer Patients". This is Part 1 of a 2-part research study. The goal of this part of the study is to plan and test an investigational type of counseling called Acceptance and Commitment Therapy, for use in patients who have or had head and neck cancer, lung cancer, breast cancer, gastrointestinal cancer, or genitour...
What is the current status of trial NCT01098955?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 51 participants. The study started on 2010-03-24. Estimated completion is 2027-09-30.
What conditions does trial NCT01098955 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Smoking Cessation.
What interventions are being tested in trial NCT01098955?
The interventions under investigation include: Varenicline (DRUG), Acceptance and Commitment Therapy (BEHAVIORAL), Motivational and Behavioral Counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT01098955?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01098955 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01098955's enrollment target sits among peer trials
51 130th of 250 higher than 120 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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