Trial record 9 of 457 for:
"tobacco use disorder"
Physician-Initiated Stop-Smoking Program for Patients Receiving Treatment for Early-Stage Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Eastern Cooperative Oncology Group
Collaborator:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00002520
First received: November 1, 1999
Last updated: November 30, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Physician-initiated smoking cessation strategies may be effective in getting early-stage cancer patients to quit smoking.
PURPOSE: Randomized clinical trial to compare the effectiveness of a physician-initiated stop-smoking program with the usual care for patients receiving treatment for early-stage cancer.
| Condition | Intervention |
|---|---|
|
Bladder Cancer Breast Cancer Colorectal Cancer Head and Neck Cancer Lung Cancer Lymphoma Prostate Cancer Testicular Germ Cell Tumor Tobacco Use Disorder Unspecified Adult Solid Tumor, Protocol Specific |
Drug: nicotine Behavioral: Usual Care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Brief Physician-Initiated Quit Smoking Strategies for Clinical Oncology Settings |
Resource links provided by NLM:
Genetics Home Reference related topics:
bladder cancer
breast cancer
mycosis fungoides
Sézary syndrome
MedlinePlus related topics:
Bladder Cancer
Breast Cancer
Cancer
Colorectal Cancer
Fungal Infections
Head and Neck Cancer
Hodgkin Disease
Leukemia
Lung Cancer
Lymphoma
Prostate Cancer
Quitting Smoking
Smoking
Testicular Cancer
U.S. FDA Resources
Further study details as provided by Eastern Cooperative Oncology Group:
Primary Outcome Measures:
- Rate of Smoking Cessation at 6 months [ Time Frame: Assessed at 6 months ] [ Designated as safety issue: No ]Proportion of patients who have quit smoking 6 months after the intervention
| Enrollment: | 434 |
| Study Start Date: | June 1992 |
| Primary Completion Date: | February 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Quit Smoking Intervention
Patients received advice and help to quit smoking. The intervention employed physician and patient resources that had already been developed and evaluated or pre-tested, including written materials, prescriptions for nicotine replacement, counseling, and follow-up contact.
|
Drug: nicotine |
|
Active Comparator: Usual Care
No special intervention after randomization. "Usual care" may or may not include advice or assistance to stop smoking. Physicians were reassured that "usual care" did not preclude quit smoking counseling.
|
Behavioral: Usual Care |
Detailed Description:
OBJECTIVES:
- Compare the efficacy of brief physician-initiated smoking cessation strategies vs usual care in patients with early stage cancer who are undergoing treatment in clinical oncology settings.
- Compare the sociodemographic, smoking history, and health status correlates of smoking cessation in patients treated with these regimens.
- Determine the feasibility of conducting a cancer prevention and control study in a cooperative group setting by monitoring adherence to the smoking-cessation strategies.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive usual care (no special intervention).
- Arm II: Patients receive smoking-cessation therapy based on the 4-step intervention plan in the "Manual for Physicians" published by the National Cancer Institute. The smoking cessation coordinator and physician provide self-quitting advice and support to the patient via counseling, self-help materials, and referral to a smoking cessation counselor at the Cancer Information Service (CIS). Patients receive nicotine replacement, if indicated. Patients who express an interest in more intensive treatment are referred to local American Cancer Society or American Lung Association clinics and/or advised to call the CIS for additional local program referrals.
All patients are followed at 6 and 12 months. Patients who report that they are still smoking and interested in help to quit smoking at the 12-month follow-up interview are encouraged to return to their physicians and contact the CIS for additional help quitting or for a referral to more intensive or specialized treatments in their area.
PROJECTED ACCRUAL: A total of 494 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
One of the following diagnoses:
- Stage I or II bladder, colorectal, head and neck, lung, or other cancer
- Stage I-III testicular cancer
- Stage I-IV breast cancer, prostate cancer, or lymphoma
- Must have smoked 1 or more cigarettes within the past month or define self as a smoker
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 19 and over
Sex:
- Not specified
Menopausal status:
- Not specified
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Cardiovascular:
- No history of recent heart attack
Other:
- Not pregnant
- No other imminent medical needs requiring referral to a more intensive smoking cessation regimen
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No prior participation in the pilot phase study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002520
Locations
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
| Study Chair: | Paul F. Engstrom, MD | Fox Chase Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Eastern Cooperative Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00002520 History of Changes |
| Other Study ID Numbers: | CDR0000078281, U10CA021115, E-1Y92, NCI-P93-0042 |
| Study First Received: | November 1, 1999 |
| Last Updated: | November 30, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eastern Cooperative Oncology Group:
|
tobacco use disorder stage I adult Hodgkin lymphoma angioimmunoblastic T-cell lymphoma stage II adult Hodgkin lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma stage I colon cancer stage II colon cancer stage I breast cancer AIDS-related peripheral/systemic lymphoma AIDS-related primary CNS lymphoma anaplastic large cell lymphoma contiguous stage II adult diffuse large cell lymphoma contiguous stage II adult diffuse mixed cell lymphoma contiguous stage II adult diffuse small cleaved cell lymphoma |
contiguous stage II adult Burkitt lymphoma contiguous stage II adult immunoblastic large cell lymphoma contiguous stage II adult lymphoblastic lymphoma contiguous stage II grade 1 follicular lymphoma contiguous stage II grade 2 follicular lymphoma contiguous stage II grade 3 follicular lymphoma contiguous stage II mantle cell lymphoma intraocular lymphoma limited stage small cell lung cancer noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II adult Burkitt lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult lymphoblastic lymphoma |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Urinary Bladder Neoplasms Breast Neoplasms Colorectal Neoplasms Head and Neck Neoplasms Lung Neoplasms Lymphoma Lymphoma, Non-Hodgkin Prostatic Neoplasms Lymphoma, Large-Cell, Immunoblastic Neoplasms, Germ Cell and Embryonal Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms |
Urinary Bladder Diseases Urologic Diseases Breast Diseases Skin Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases |
ClinicalTrials.gov processed this record on May 21, 2013