Clinical trial NCT01685723: Smoking Cessation in Cancer Patients
Official title: Helping Cancer Patients Quit Smoking Using Brief Advice Based on Risk Communication: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Smoking Cessation
Keywords: Cancer patients
Smoking cessation
Risk communication
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Food and Health Bureau, Hong Kong
name: Queen Mary Hospital, Hong Kong
name: Tuen Mun Hospital
name: Queen Elizabeth Hospital, Hong Kong
name: Princess Margaret Hospital, Hong Kong
name: Pamela Youde Nethersole Eastern Hospital
First posted: 2012-09-14
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Smoking cessation can largely improve cancer prognosis and quality of life among cancer patients. However, few patients are aware of the importance to quit at the stage, or they have difficulties to quit by self.

Aim: to examine the effectiveness of a smoking cessation intervention using a risk communication approach

Design: A randomized controlled trial

Setting: Outpatient clinics of the Clinical Oncology Departments of five major hospitals in different regions of Hong Kong

Subject: Smokers who attend medical follow-up visits at outpatient clinics of the Clinical Oncology Departments of five major hospitals in different regions of Hong Kong and who met the inclusion criteria were invited to participate.

Intervention: At baseline, intervention group receives:

1. a face-to-face individualized brief advice based on risk communication for 15-30 minutes from the nurse counselors;
2. examination of exhale CO level; and
3. a generic standard self-help smoking cessation booklet. They will receive a booster intervention at 1 week. Control group will receive standard care and a generic self-help smoking cessation booklet.

Outcome: Primary outcome is the self-reported 7-day point prevalence quit rate at 6-month follow up. Secondary outcomes include:

1. self-reported 7-day point-prevalence smoking abstinence at 12-month follow-up;
2. biochemically validated quit rate at 6-month follow-up; and
3. percentage of patients reduced smoking by at least 50% at 6- and 12-month follow-up compared to baseline.

Significance: This study develops and validates practical smoking cessation interventions targeted to cancer patients to improve their cancer prognosis and in long-term.

Detailed description: Smoking causes many types of cancer in general. Past studies have shown that current smokers have increased risk of cancer, and most lung cancers are attributable to smoking. Cancer (malignant neoplasm) is the number one killer in Hong Kong, which leads to nearly one-third of all deaths each year. Cancer patients who continue smoking would result in extra risks of all cause mortality, cancer recurrence and second primary cancer as well as reducing survival time (Chen et al., 2010). Smoking could also reduce the efficacy of clinical and medical treatment of cancer including radio- and chemo-therapies (Benninger et al., 1994; Browman et al., 1993) and increase the risk of treatment related side-effects (Rugg et al., 1990).

Cancer patients may present an excellent "teachable moment" for smoking cessation interventions, as their current illness could largely be due to smoking. However, few smoking cessation programs target on this vulnerable group and only one-third of oncology nurses would assist cancer patients quit smoking. Healthcare professionals have the responsibility to assist this vulnerable group to quit smoking. Recent randomized controlled trials (RCT) suggested behavioral intervention may help cancer patients quit smoking, but they are limited by small sample size. No RCT study has ever been done in Hong Kong.

This study can make an important contribution to evidence-based practice by testing the effectiveness of a smoking cessation intervention using a risk communication approach and targeting cancer patients. The results primarily serve the purpose to support the development of clinical practice guidelines and interventions to promote smoking cessation in cancer patients to improve their cancer prognosis and, in the long-run, increase their survival time and quality of life.

Eligibility criteria: Inclusion Criteria:

* patients smoked at least weekly in the past 6 months;
* diagnosed with cancer not limited to smoking-induced cancers;
* patients in all stages 0,I,II,III, or IV;
* aged 18 or above; and
* can communicate in Cantonese

Exclusion Criteria:

* those with unstable medical conditions as advised by the doctor in charge;
* poor cognitive state or with mental illness; and
* those participating in other smoking cessation program.

Primary outcomes:
measure: The self-reported 7-day point prevalence (pp) quit rate at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: The self-reported 7-day point prevalence (pp) quit rate at 12 months
timeFrame: 12 months
measure: Biochemical validation of smoking status at 6 months
timeFrame: 6 months
measure: Percentage of patients reduced smoking by at least 50% at 6 months
timeFrame: Baseline and 6 months
measure: Percentage of patients reduced smoking by at least 50% at 12 months
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Sophia SC Chan, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Browman GP, Wong G, Hodson I, Sathya J, Russell R, McAlpine L, Skingley P, Levine MN. Influence of cigarette smoking on the efficacy of radiation therapy in head and neck cancer. N Engl J Med. 1993 Jan 21;328(3):159-63. doi: 10.1056/NEJM199301213280302.
citation: Rugg T, Saunders MI, Dische S. Smoking and mucosal reactions to radiotherapy. Br J Radiol. 1990 Jul;63(751):554-6. doi: 10.1259/0007-1285-63-751-554.
citation: Chen J, Jiang R, Garces YI, Jatoi A, Stoddard SM, Sun Z, Marks RS, Liu Y, Yang P. Prognostic factors for limited-stage small cell lung cancer: a study of 284 patients. Lung Cancer. 2010 Feb;67(2):221-6. doi: 10.1016/j.lungcan.2009.04.006. Epub 2009 Jun 3.
citation: Li WH, Chan SS, Wang KM, Lam TH. Helping cancer patients quit smoking by increasing their risk perception: a study protocol of a cluster randomized controlled trial. BMC Cancer. 2015 Jun 30;15:490. doi: 10.1186/s12885-015-1496-2.