Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Physician-Initiated Stop-Smoking Program for Patients Receiving Treatment for Early-Stage Cancer

Summary: 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.

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: 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

Relevance to patient case: not relevant