NCT01685723

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. 1.a face-to-face individualized brief advice based on risk communication for 15-30 minutes from the nurse counselors;
  2. 2.examination of exhale CO level; and
  3. 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.
  4. 4.self-reported 7-day point-prevalence smoking abstinence at 12-month follow-up;
  5. 5.biochemically validated quit rate at 6-month follow-up; and
  6. 6.percentage of patients reduced smoking by at least 50% at 6- and 12-month follow-up compared to baseline.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
528

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2012

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 14, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

2.5 years

First QC Date

August 26, 2012

Last Update Submit

January 19, 2018

Conditions

CancerSmoking Cessation

Keywords

Cancer patientsSmoking cessationRisk communication

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • The self-reported 7-day point prevalence (pp) quit rate at 12 months

    12 months

  • Biochemical validation of smoking status at 6 months

    6 months

  • Percentage of patients reduced smoking by at least 50% at 6 months

    Baseline and 6 months

  • Percentage of patients reduced smoking by at least 50% at 12 months

    Baseline and 12 months

Study Arms (2)

Counseling group

EXPERIMENTAL

Subjects in this group will receive a face-to-face individualized brief advice based on risk communication for 15-30 minutes from the nurse counselors and a booster intervention (10-15 minutes) at 1 week. Data collection will be conducted at 1 week, 1, 3, 6, 9, 12 months via telephone.Ten subjects from the intervention group who have not quitted will be invited for a process evaluation in the form of face-to-face interviews by research assistants at 12-month follow-up.

Behavioral: Counseling group

General supporting

SHAM COMPARATOR

Subjects in this group will receive standard care without risk communication. Data collection will be conducted at 1 week, 1, 3, 6, 9, 12 months via telephone.

Behavioral: General supporting

Interventions

Counseling groupBEHAVIORAL

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.

Counseling group
General supportingBEHAVIORAL

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.

General supporting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

Related Publications (5)

  • 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. doi: 10.1288/00005537-199403000-00009.

    PMID: 8127185BACKGROUND

  • 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.

    PMID: 8417381BACKGROUND

  • 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.

    PMID: 2390690BACKGROUND

  • 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.

    PMID: 19497635BACKGROUND

  • 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.

    PMID: 26122078DERIVED

MeSH Terms

Conditions

NeoplasmsSmoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Sophia SC Chan, PhD, MPH

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 26, 2012

First Posted

September 14, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2016

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

CN(1)