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Tobacco-Related CarcinomaNCT07049757

Healthy Family Project: Tobacco Use and Smoke Exposure in Asian American Communities

A study testing Smoking cessation education, Survey Administration and Telephone-Based Intervention in people with Tobacco-Related Carcinoma and Smoking Cessation, run by University of California, San Francisco at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study evaluates whether the Smokefree Family Living (SFL) intervention improves quit rates (smoking cessation) and exposure to tobacco contamination that stays in items such as, carpets, walls, and furniture, even after the smoke has cleared (third-hand smoke (THS)) among Chinese American smokers and their… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Tobacco-Related Carcinoma, Smoking Cessation
What is being tested?
Smoking cessation education, Survey Administration and Telephone-Based Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
760 participants
Where
1 siteUnited States
Study dates
23 Mar 2026to 30 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All Participants (Lay Health Workers, Smokers, Family Participants, and Post-Trial Household Member Group Interview Participants):
  • Must be 18 years of age or older.
  • Must self-identify as Chinese or of Chinese descent (ethnic or cultural identification, not national origin).
  • Must be able to understand in spoken Chinese (Cantonese and/or Mandarin) or English.
  • Able to attend educational sessions in person or via video conferencing.
  • Ability to understand and the willingness to sign a written informed consent document.
Show all 20Show fewer
  • Have a mobile phone that can receive Short Message Service (SMS) text messages, or an email address and a phone number where they can be reached by the study team.
  • Lay Health Workers:
  • Must have experience or interest in community outreach and education.
  • Must demonstrate proficiency in language (Cantonese and/or Mandarin or English) sufficient to deliver study materials and interact with participants.
  • Must be affiliated with the Chinese Community Health Resource Center (CCHRC) or recruited through community networks.
  • Must agree to participate in training and intervention delivery activities as outlined in the study protocol.
  • Smokers (Participants who are current smokers):
  • Must have smoked within the past 30 days, either daily or occasionally.
  • Must have a non-smoking household member.
  • Family Participants (Non-smoking family/household members):
  • Must live in the same household as the smoker participant.
  • Must not have used any tobacco products in the past 30 days.
  • Post-Trial Household Member Group Interview Participants:
  • 1. Living in the same household with the smoker-household member dyad participant being interviewed or considered as a household member.

Who cannot join

  • Lay Health Workers, Smokers (Participants who are current smokers) and Family Participants (Non-smoking Family/household members):
  • Currently participating in another smoking cessation program.
  • Non-residents of California.
  • Participants unwilling to provide follow-up contact for assessments at 6 and 12 months.
  • Lay Health Workers:
  • Lack of willingness or ability to complete training or deliver intervention sessions as required by the study protocol.
  • Inability to maintain confidentiality and professionalism during interactions with study participants.
  • Active participation in conflicting research studies or programs.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • University of California, San Francisco

    San Francisco, California, 94143

    Edgar Yu, edgar.yu@ucsf.edu

    877-827-3222, cancertrials@ucsf.edu

    Recruiting

Other trials in United States

About this study

Official title: Healthy Family Project: Ending Tobacco Use and Smoke Exposure in Asian American Communities

This study evaluates whether the Smokefree Family Living (SFL) intervention improves quit rates (smoking cessation) and exposure to tobacco contamination that stays in items such as, carpets, walls, and furniture, even after the smoke has cleared (third-hand smoke (THS)) among Chinese American smokers and their non-smoking household members. Smoking remains high among Chinese American males with limited ability to speak English. This causes the non-smoking household members to be exposed to THS, which contains many of the same harmful components as smoking and becomes more toxic as it ages. SFL is tailored for Chinese Americans and combines the contents of the Quit Smoking for a Healthy Family (QS) intervention with additional THS education and cleaning strategies. QS focuses on smoking cessation through educational sessions and support. THS education and cleaning strategies provide information on THS and how to clean the home for THS. SFL may help Chinese American smokers and their non-smoking household members learn about the importance of quitting and the dangers of THS, this may improve smoking cessation and reduce THS exposure

Read the detailed description

PRIMARY OBJECTIVES:

  1. Integrate the original "Quit Smoking for a Healthy Family" (QS) curriculum with the third-hand smoke education and cleaning intervention (THS) into a new intervention titled "Smokefree Family Living" (SFL) for Chinese immigrant families and household members.

II. Examine the efficacy of SFL by measuring smoking cessation rates at six months and the reduction in third-hand smoke exposure among smokers and nonsmoking household member participants, respectively, using a 2-arm randomized trial targeting 320 smoker-household member dyads from the Chinese American communities.

SECONDARY OBJECTIVE:

  1. Examine individual and social pathways mediating the outcomes for cessation attempts, abstinence, and tobacco smoke exposure.

EXPLORATORY OBJECTIVES:

  1. Explore the long-term impacts of the THS education and the timing of the accessibility of the THS intervention by examining time to first 30-day quit attempts and duration of quit attempts after exposure to THS intervention in both intervention groups of a subsample available for 12-month follow-up.

II. To compare the long-term efficacy of the SFL and QS interventions in sustaining smoking cessation and reducing tobacco smoke exposure.

III. To evaluate the feasibility and effectiveness of using silicone wristbands to measure third-hand smoke (THS) exposure among non-smoking household members of Chinese American smokers participating in the study.

IV. Assess the behavioral changes related to smoking and smoke exposure, as well as the psychosocial impact of the interventions on participants and their household members.

OUTLINE:

A family-based intervention development phase prior to the randomized study will integrate the original "Quit Smoking for a Healthy Family" (QS) curriculum of the Healthy Family Project with the third-hand smoke education and cleaning intervention (THS) into a newly integrated intervention named "Smokefree Family Living" (SFL) for Chinese immigrant families and household members. Information collected from this group will be used to refine and develop the final SFL intervention used in the subsequent clinical trial. These participants will not be included in final study analyses.

Participants enrolled after the focus group data has been evaluated for implementation will be randomized to 1 of 2 arms.

Arm I: Participants attend two QS educational sessions over 45-60 minutes one month apart and receive two follow-up phone calls over 15-30 minutes 1-2 weeks after each session over 6 weeks. Participants also receive a Healthy Family Action Plan as well as a smoking cessation resource guide and set goals on study. Participants then receive THS education and cleaning strategies at 6 months. Additionally, participants undergo urine sample collection throughout the study.

Arm II: Participants attend two QS educational sessions over 45-60 minutes one month apart and receive two follow-up phone calls over 15-30 minutes 1-2 weeks after each session over 6 weeks. During the second QS educational session, participants receive THS education and cleaning strategies. Participants also receive a Healthy Family Action Plan as well as a smoking cessation resource guide and set goals on study. Additionally, participants undergo urine sample collection throughout the study.

After completion of study intervention, participants are followed up at 6 and 12 months.

Being tested
Smoking cessation education, Survey Administration, Telephone-Based Intervention, Urine Specimen Collection, Silicone Wrist Band
Keywords
Third-hand Smoke
Medical subject headings
Smoking Cessation

What participants receive

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

  • Smoking cessation educationOther

    Also called Education for Intervention, Intervention by Education, Intervention through Education

    Quit Smoking for a Healthy Family (QS) and Smokefree Family Living (SFL) education sessions to promote smoking cessation and reduce tobacco smoke exposure.

  • Survey AdministrationBehavioural

    Also called Questionnaires

    Administered for ancillary studies

  • Telephone-Based InterventionBehavioural

    Also called Telephone-Based Follow-up

    Participants will receive follow-up calls

  • Urine Specimen CollectionProcedure or surgery

    Also called Urine Sample

    Undergo urine sample collection at baseline

  • Silicone Wrist BandOther

    Non-smoking family/household members will wear a silicone wristband for 2 days at each assessment for ancillary studies

  • InterviewOther

    Also called In-depth interview

    Selected participants will take part in an interview for ancillary studies

  • Focus GroupOther

    Participants will review and comment on materials under development to be used in randomized clinical trial.

Study groups in NCT07049757
Study groupRoleWhat they receive
Intervention Development (Focus group + Interview)ExperimentalTo achieve information gathering and preliminary adaptation design to prepare for the randomized clinical trial, focus groups and individual interviews with 24 participants (6 Chinese current smokers; 6 former smokers who have stopped smoking within the past 2 years; and 12 family/household members living with a current/former smoker) to review the newly developed or updated intervention materials. The Community Advisory Board (CAB) will also be involved in providing input.
Receives: Other: Focus Group
Arm I: Quit Smoking for a Healthy Family Group (QS)Active comparatorParticipants attend two QS educational sessions over 45-60 minutes one month apart and receive two follow-up phone calls over 15-30 minutes 1-2 weeks after each session over 6 weeks. Participants also receive a Healthy Family Action Plan as well as a smoking cessation resource guide and set goals on study. Participants then receive THS education and cleaning strategies at 6 months after the initial QS curriculum. Additionally, participants undergo urine sample collection throughout the study and non-smoking family/household members will wear a silicone wristband for 2 days at each assessment.
Receives: Other: Smoking cessation education; Behavioral: Survey Administration; Behavioral: Telephone-Based Intervention; Procedure: Urine Specimen Collection; Other: Silicone Wrist Band; Other: Interview
Arm II: Smokefree Family Living Group (SFL)ExperimentalParticipants attend two QS educational sessions over 45-60 minutes one month apart and receive two follow-up phone calls over 15-30 minutes 1-2 weeks after each session over 6 weeks. During the second QS educational session, participants receive THS education and cleaning strategies. Participants also receive a Healthy Family Action Plan as well as a smoking cessation resource guide and set goals on study. Additionally, participants undergo urine sample collection throughout the study and non-smoking family/household members will wear a silicone wristband for 2 days at each assessment.
Receives: Other: Smoking cessation education; Behavioral: Survey Administration; Behavioral: Telephone-Based Intervention; Procedure: Urine Specimen Collection; Other: Silicone Wrist Band; Other: Interview

What is being measured

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

  1. Proportion of participants who have quit smoking at 6 months

    The smoking cessation rate is defined as the proportion of smokers who report quitting smoking, with biochemically verified 30-day point prevalent abstinence at the 6-month follow-up. Smoking rates will be reported by arm.

    Measured: 6 months

Secondary outcomes (2)
  1. Change in levels of tobacco smoke biomarkers for second-(SHS)hand smoke exposure

    The change in level of tobacco smoke exposure will be assessed among non-smoking family/household members by reviewing levels of urinary 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) at baseline and at 6 months.

    Measured: Up to 6 months

  2. Proportion of participants who have quit smoking at 12 months

    The smoking cessation rate is defined as the proportion of smokers who report quitting smoking, with verified 30-day point prevalent abstinence by biochemical markers (e.g., urinary NNAL and cotinine tests) at the 12-month follow-up. Smoking rates will be reported by arm.

    Measured: Up to 12 months

Timeline

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

  1. First posted3 Jul 2025
  2. Study start23 Mar 2026
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion30 Sep 2028 (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
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
760 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07049757
Sponsor's protocol ID
24634
Other IDs
NCI-2025-00206
Status last verified
May 2026
First submitted
25 Jun 2025
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
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 Smoking cessation education, Survey Administration and Telephone-Based Intervention in people with Tobacco-Related Carcinoma and Smoking Cessation, run by University of California, San Francisco at 1 site in United States.

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 20 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 4 Jun 2026. 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 United States. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Edgar Yu (877-827-3222, edgar.yu@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants who have quit smoking at 6 months (time frame: 6 months). 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 4 Jun 2026.

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