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Smoking CessationNCT03717662

Promoting Women's Health: A Gender Specific Smoking Cessation Program for Female Smokers in Hong Kong

A study testing nicotine gum or nicotine patch in people with Smoking Cessation, run by The University of Hong Kong at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This project aims to publicize quitting among female smokers, and encourage and support those who want to quit by providing face-to-face and/or telephone counseling. The objectives are to: 1. Read more about this study

Who is it for?
Ages 15 years and older, women only
Conditions the study is for
Smoking Cessation
What is being tested?
nicotine gum or nicotine patch
Could I receive a placebo?
No, everyone receives an active treatment
How many people
480 participants
Where
1 siteChina
Study dates
1 Apr 2006to 30 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Hong Kong female resident aged 18 or above
  • Able to communicate in Chinese (Cantonese)
  • Current Smokers

Who cannot join

  • Have difficulty to communicate via telephone
  • Having queries irrelevant to tobacco control

Trial locations and contacts

1 site in 1 country.

Ho-Cheung Li, PhD contact

39176634

william3@hku.hk

China1 site, 1 recruiting
  • The University of Hong Kong

    Hong Kong

    Ho Cheung William Ho, PhD, 852-39176634, william3@hku.hk

    Ho Cheung William Li, PhD

    Recruiting

Other trials in China

About this study

This project aims to publicize quitting among female smokers, and encourage and support those who want to quit by providing face-to-face and/or telephone counseling. The objectives are to:

  1. Build up a Women Against Tobacco Taskforce (WATT) with woman volunteers from various organizations to promote quitting in female smokers, and to arouse public awareness of the effects of smoking on sexual, reproductive and child health, and other diseases among women.
  2. Conduct a survey among the women volunteers and staff of the women's organization to ascertain their learning needs, knowledge, attitudes, and practice of tobacco control and smoking cessation, and to identify interested participants to join the smoking cessation training program.
  3. Design and deliver a smoking cessation counseling training program (based on the learning needs identified), to equip women volunteers with the knowledge and skills in smoking cessation.
  4. Develop and evaluate a gender-specific smoking cessation program to help female smokers to reduce and quit smoking.
  5. Promote women's health and quality of life, and reduce the life-long morbidity and mortality of female smokers in the long term.
  6. Examine the long term (3-year) impact of a gender-specific smoking cessation program on the smoking behaviors of female smokers.
  7. Examine another long-term (6-year) impact of a gender-specific smoking cessation program on the smoking behaviors of female smokers.
  8. Ascertain the contributing factors in the rate of quitting, retention and relapse.
  9. Investigate Hong Kong women smokers awareness and attitude to women quitline.
Read the detailed description

Phase I: Build up a network and need assessment

  1. We will invite collaboration with the Hong Kong Women Development Association (18 organizational members and over 30,000 individual members), the Hong Kong Federation of Women (45 organizational members), Women's Club of Family Planning Association (7 Women's Club), Hone Kong Young Women's Christian Association (around 260,000 members) and other woman organizations to build up a network by setting up a Women Against Tobacco Taskforce (WATT) jointly with representatives from women organizations and led by the Department of Nursing Studies of The University of Hong Kong. This proposed Task Force will focus on promoting smoking cessation among female smokers and arousing the public's awareness of health risks specific to women from smoking.
  2. Need assessment survey and focus group interview of the women volunteers and staff: all volunteers and staff will be invited to participate in a need assessment survey and focus group interview. The perceived needs identified will be used to design a tailor-made smoking cessation counselor training curriculum for the participants, and they will be asked to indicate their interest and commitment to undertake such training (free of charge), and to help women quit smoking.

Phase II:

Design and deliver training curriculum: Based on the needs assessment data, we will design and deliver a tailor-made smoking cessation counseling training program for the woman volunteers and staff. A maximum capacity of 200 participants can be trained. At the end of the program, participants should be capable of delivering smoking cessation advice for women, and a referral system can be set up so that women that required more intensive counseling can be referred to us if necessary. The outcome of the training will be evaluated through a survey before and immediate after, and 6 months post training, which include: knowledge, attitudes, and practice of smoking cessation.

We aim to train women smoking cessation counselors as they can better understand the needs and feelings of female smokers. Female addiction to cigarette smoking may be reinforced more by the sensory and social context of smoking2, and therefore it is important to reduce the gap between the female smoker and the counselor. Upon completion of the program, a certificate of attendance will be awarded to the participants and their organizations for their contribution.

Phase III:

  1. Brief gender-specific advice provided by trained women volunteers: The trained women counselors will use motivational approach to provide smoking cessation advice to female smokers.
  2. Intensive gender-specific intervention provided by experience nurse counselor: The project will provide intensive counseling at the Centre for Health Promotion (CHP) of HKU Department of Nursing Studies, female smokers (including all types of tobacco products such as shisha, electronic cigarettes and heat-not-burn (HNB) which are available in the market) who require more intensive counseling or advice on nicotine replacement therapy, upon referral from the women's organizations and trained women counselors. The smokers will receive face-to-face (or telephone) counseling and a 1 week supply of Nicotine replacement therapy (NRT) (4 mg nicotine gum or 10 mg/ 15 mg nicotine patch) from the nurse counselor, and follow up calls at 1 week, 1-, 3-, 6-, 36- and 72-month post-intervention. Their smoking status, information about usage of nicotine replacement products and quality of life measures will be assessed. All women reported to have quit smoking at 6-, 36- and 72-month will be invited for biochemical validation (measurement of urine / saliva cotinine level). Participants will be invited to do qualitative interviews (individual / focus group interviews) at the 36-month follow up. Interviews will be conducted according to participants' smoking status (3 levels: continuous smoker; those who had quit attempts but relapsed; and those who abstained from tobacco within the 3-year period) and martial status (2 levels: single; and married). 30 participants with 5 subjects per group will be recruited. Each interview will last for 60 minutes and to be conducted by an experienced facilitator at the School of Nursing, The University of Hong Kong. During each individual interview, the facilitator will first welcome the participants, obtain written consent, and assure that the interview will be audio-taped and kept confidential. The facilitator will guide the discussion using an interview guide and prompt for further information as necessary.

Phase IV:

The trained women counsellors will observe the women smokers on the street and walk forward to look for opportunities talking to them. Counsellors will first explain the basic information of this research and acquire their reliance. After we got the permission to conduct a small interview, smokers will be asked a few questions about their awareness about women quitline and obstruction to call the quitline. Each interview will last no more than 10 minutes. We can invite them to participate in a further phone call survey and encourage them to leave their phone number.

Being tested
nicotine gum or nicotine patch
Keywords
women
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nicotine gum or nicotine patchDrug

    The project will provide intensive counseling at the Centre for Health Promotion (CHP) of HKU Department of Nursing Studies, female smokers who require more intensive counseling or advice on nicotine replacement therapy, upon referral from the women's organizations and trained women counselors. The smokers will receive face-to-face (or telephone) counseling and a 1 week supply of Nicotine replacement therapy (NRT) (4 mg nicotine gum or 10 mg/ 15 mg nicotine patch) from the nurse counselor, and follow up calls at 1 week, 1-, 3-, 6-, 36- and 72-month post-intervention.

Study groups in NCT03717662
Study groupRoleWhat they receive
Brief counseling and NRTExperimentalThe project will provide intensive counseling at the Centre for Health Promotion (CHP) of HKU Department of Nursing Studies, female smokers (including all types of tobacco products such as shisha, electronic cigarettes and heat-not-burn (HNB) which are available in the market) who require more intensive counseling or advice on nicotine replacement therapy, upon referral from the women's organizations and trained women counselors. The smokers will receive face-to-face (or telephone) counseling and a 1 week supply of Nicotine replacement therapy (NRT) (4 mg nicotine gum or 10 mg/ 15 mg nicotine patch) from the nurse counselor, and follow up calls at 1 week, 1-, 3-, 6-, 36- and 72-month post-intervention.
Receives: Drug: nicotine gum or nicotine patch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 7-days point prevalence smoking abstinence at 6-month

    the reduced cigarette consumption; progression to a higher stage of readiness to change; quit attempts, and increased self-efficacy to quitting smoking. In the long term, the quit rate (not smoke for at least 7 days during the time of follow up); smoking reduction, progression of stage of readiness, at 6 months; and change in quality of life

    Measured: 6-month follow-up

Secondary outcomes (1)
  1. Bio-chemical validated smoking abstinence at 6-,36-,72-month

    Bio-chemical validated smoking abstinence is measured at 6-,36-,72-month. The participants who claim to have quitted smoking for at least 7 days are invited for biochemical validation (measurement of saliva cotinine level and exhaled carbon monoxide level) at 6-month. The participants are need to get the results of CO≤ 4ppm, and continine level ≤30 ng/ml as passing results.

    Measured: 6-,36-,72-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2018
  2. Study start1 Apr 2006
  3. Primary completion1 Oct 2024 (estimated)
  4. Study completion30 Nov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
480 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03717662
Sponsor's protocol ID
UW 06-323
Status last verified
Dec 2020
First submitted
22 Oct 2018
Last updated
21 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing nicotine gum or nicotine patch in people with Smoking Cessation, run by The University of Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ho-Cheung Li, PhD (39176634, william3@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

7-days point prevalence smoking abstinence at 6-month (time frame: 6-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.

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