Smoking Cessation in Cancer Patients

Cancer Clinical Trial

Official title:

Helping Cancer Patients Quit Smoking Using Brief Advice Based on Risk Communication: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01685723
• Other study ID #: cancer_rct_1
• Status: Completed
• Phase: N/A
• First received: August 26, 2012
• Last updated: January 19, 2018
• Start date: September 2012
• Est. completion date: March 2016

Study information

• Verified date: January 2018
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 528
• Est. completion date: March 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Smoking Cessation

Intervention

Behavioral:
• Counseling group
Subjects will receive brief advice based on risk communication by a nurse counselor. The brief advice will be based on a specifically-designed risk communication leaflet that warns about the risks of continued smoking for subjects' cancer treatment and prognosis. Subjects will receive a booster intervention via telephone at 1 week to assess the progress of and barriers to the subjects' action plans and identifying individual difficulties and facilitators towards quitting. They also receive a generic standard self-help smoking cessation booklet.
• General supporting
Subjects in this group will receive a generic self-help smoking cessation booklet and standard care without risk communication. They will have the same follow-up sections as the intervention group to receive diseases support.

Locations

Country	Name	City	State
China	The University of Hong Kong	Hong Kong

Sponsors (7)

Lead Sponsor	Collaborator
The University of Hong Kong	Food and Health Bureau, Hong Kong, Pamela Youde Nethersole Eastern Hospital, Princess Margaret Hospital, Hong Kong, Queen Elizabeth Hospital, Hong Kong, Queen Mary Hospital, Hong Kong, Tuen Mun Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Benninger MS, Gillen J, Thieme P, Jacobson B, Dragovich J. Factors associated with recurrence and voice quality following radiation therapy for T1 and T2 glottic carcinomas. Laryngoscope. 1994 Mar;104(3 Pt 1):294-8. — View 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. — View 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. — View Citation

Rugg T, Saunders MI, Dische S. Smoking and mucosal reactions to radiotherapy. Br J Radiol. 1990 Jul;63(751):554-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The self-reported 7-day point prevalence (pp) quit rate at 6 months	Whether the participant has quitted smoking in the past seven days at the time point of 6 months	6 months
Secondary	The self-reported 7-day point prevalence (pp) quit rate at 12 months	Whether the participant has quitted smoking in the past seven days at the time point of 12 months	12 months
Secondary	Biochemical validation of smoking status at 6 months	Biochemically validated quit rate (saliva cotinine level and exhale CO test)	6 months
Secondary	Percentage of patients reduced smoking by at least 50% at 6 months	Percentage of patients reduced smoking by at least 50% at 6 months	Baseline and 6 months
Secondary	Percentage of patients reduced smoking by at least 50% at 12 months	Percentage of patients reduced smoking by at least 50% at 12 months	Baseline and 12 months