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NCT01871506 · ClinicalTrials.gov registry record · NA
Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial
A NA study of Smoking Cessation, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 303
- Enrollment target
- 3
- Study locations
NCT01871506 is a NA study of Smoking Cessation that has completed, run by Massachusetts General Hospital. The registered enrollment target is 303 participants, below the 473-participant average among 188 other Smoking Cessation trials with a reported enrollment target (36% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT01871506, a NA study of Smoking Cessation, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 303 participants
- Enrollment target
- 3
- Study locations
Study 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. 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. 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 Cessa
Conditions Studied
Interventions
- BEHAVIORAL Standard Care (SC)
- BEHAVIORAL Intensive Counseling (IC)
Study Locations (3)
Massachusetts
- Massachusetts General Hospital - Boston
- Dana-Farber Cancer Institute - Boston
New York
- Memorial Sloan-Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 303 participants |
| Start Date | 2013-09 |
| Est. Completion | 2018-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01871506
The ClinicalTrials.gov registry entry for NCT01871506 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 303 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 473-participant average among 188 other Smoking Cessation trials with a reported enrollment target (36% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Smoking Cessation appearing as the primary indexed condition, and to 2 interventions - of which Standard Care (SC) is the first listed.
NCT01871506 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT01871506 about?
NCT01871506 is a clinical study titled "Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial". 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 ris...
What is the current status of trial NCT01871506?
This trial is currently completed. It is a NA study. The enrollment target is 303 participants. The study started on 2013-09. Estimated completion is 2018-05.
What conditions does trial NCT01871506 study?
This clinical trial studies the following conditions: Smoking Cessation.
What interventions are being tested in trial NCT01871506?
The interventions under investigation include: Standard Care (SC) (BEHAVIORAL), Intensive Counseling (IC) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01871506?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01871506 being conducted?
This trial has 3 study locations across Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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