Cigarette Smoking-Related CarcinomaNCT06754215
Smoking Cessation Intervention Development for Homeless Youth
A study testing Focus Group, Interview and Smoking Cessation Intervention in people with Cigarette Smoking-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This trial develops a contextually tailored and optimized smoking cessation intervention and studies smoking motivations and motivations to quit smoking in homeless youth. Identifying motivations for smoking and motivations to quit smoking may help researchers build a program to help homeless young people quit smoking… Read more about this study
- Who is it for?
- Ages 14 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking-Related Carcinoma
- What is being tested?
- Focus Group, Interview and Smoking Cessation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2017to 26 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Youth who report having smoked some or every day in the past week.
- Youth who meet criteria for homelessness defined by the 2002 McKinney-Vento Act including those who lack a fixed, regular, and adequate nighttime residence; live in a welfare hotel, or place without regular sleeping accommodations; or live in a shared residence with other persons due to the loss of one's housing or economic hardship.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Development of a Contextually Tailored and Optimized Smoking Cessation Intervention for Homeless Youth
This trial develops a contextually tailored and optimized smoking cessation intervention and studies smoking motivations and motivations to quit smoking in homeless youth. Identifying motivations for smoking and motivations to quit smoking may help researchers build a program to help homeless young people quit smoking cigarettes if desired.
Read the detailed description
PRIMARY OBJECTIVES:
- Establish a theoretical framework for cessation among homeless youth incorporating phase-specific capabilities and opportunities impacting motivation to engage in cessation. (Multiphase Optimization STrategy [MOST] Step 1) II. Guided by the theoretical framework for cessation among homeless youth, identify a set of cessation intervention components and assess their implementation feasibility. (MOST Step 2)
OUTLINE:
MOST STEP Ia: Participants attend a semi-structured interview over 60 minutes to help establish theoretical model of contextually tailored smoking cessation for homeless youth.
MOST STEP Ib: Participants complete a survey to help establish theoretical model of contextually tailored smoking cessation for homeless youth.
MOST STEP II (FOCUS GROUPS): Participants attend focus groups to help identify a set of cessation intervention components for homeless youth and determine component acceptability and feasibility.
MOST STEP II (FEASIBILITY STUDY): Intervention components are identified and selected from Focus Groups. Participants take part in a study to assess these components for feasibility in implementing in coordination with homeless youth services, as well as determining main effect estimates for future studies.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- Focus Group, Interview, Smoking Cessation Intervention, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupBehavioural
Participate in focus group
InterviewOther
Participate in semi-structured interview
Smoking Cessation InterventionBehavioural
Also called Smoking and Tobacco Use Cessation Interventions
Participate in feasibility study of intervention components
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| MOST STEP Ia (interview) | Experimental | Participants attend a semi-structured interview over 60 minutes to help establish theoretical model of contextually tailored smoking cessation for homeless youth. Receives: Other: Interview |
| MOST STEP Ib (survey) | Experimental | Participants complete a survey to help establish theoretical model of contextually tailored smoking cessation for homeless youth. Receives: Other: Survey Administration |
| MOST STEP II (feasibility study) | Experimental | Intervention components are identified and selected from Focus Groups. Participants take part in a study to assess these components for feasibility in implementing in coordination with homeless youth services, as well as determining main effect estimates for future studies. Receives: Behavioral: Smoking Cessation Intervention |
| MOST STEP II (focus groups) | Experimental | Participants attend focus groups to help identify a set of cessation intervention components for homeless youth and determine component acceptability and feasibility. Receives: Behavioral: Focus Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Youth's Psychological and Physical Capacity
Factors associated with participant's psychological and physical capacity which have prompted them to smoke in the past were captured during semi-structured interviews. In-person interviews followed a semi-structured interview guide. Questions were grounded in the Capability-Opportunity-Motivation for Behavior model, a theoretical framework that describes how intersecting psychosocial and environmental factors influence behavior. Questions were designed to elicit data on factors influencing tobacco use at a specific moment in time (participants' "last smoke") with the intent to optimize supportive cessation interventions for this population.
Measured: 60 minute semi-structured interview
Youth's Physical and Social Factors
Coping with homelessness was assessed using the Brief COPE to examine strategies used for coping or regulating cognition in response to stressors; participants were specifically asked to focus on their housing situation. This measure includes 28 items combined to form 14 subscales. Scores on each subscale range from 2 to 8 with higher scores indicating greater use of the strategy.
Measured: Approximately 90 minute interview
Motivation to Quit
Interest in quitting in the next 30 days is an exemplar Phase-Based Model (PBM) for Cessation Research motivation phase treatment outcome measure. Participants reported if and when they planned to quit, derived from, "Do you plan to quit for good?" and "When do you plan to quit for good? In the next (7 days, 30 days, 6 months, year, more than a year from now)."
Measured: Approximately 90 minute interview
Past Quit Attempts
Number of past year quit attempts: a proxy for past willingness to quit. Participants reported the number of quit attempts in the past year: "In the past 12 months, how many times have you quit smoking for at least 24 hours in a serious attempt to quit?"
Measured: Approximately 90 minute interview
Confidence in Ability to Quit in Next 6 Months
Confidence in ability to quit in the next 6 months was measured with: "If you did try quitting smoking altogether in the next 6 months, how likely do you think you would be to succeed - not at all, a little likely, somewhat likely or very likely?"
Measured: Approximately 90 minute interview
Motivations for Smoking
The Tobacco Motives Inventory was used; 15 questions, each scored on a 5-point Likert scale, were combined into four sub-scales: social motives, self enhancement motives, boredom relief motives, and affect regulation motives. Higher scores on each sub-scale indicate a higher motivation to smoke.
Social motives: Sum of 4 items, scores range from 4 to 20 Self enhancement motives: Sum of 4 items, scores range from 4 to 20 Boredom relief motives: Sum of 2 items, scores range from 2 to 10 Affect regulation motives: Sum of 5 items, scores range from 5 to 25
Measured: Approximately 90 minute interview
Rewards From Quitting Smoking
We measured 15 different rewards from smoking: "What are the benefits of smoking to you? Check all that apply"
Measured: Approximately 90 minute interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start20 Sep 2017
- Primary completion26 Apr 2023
- Study completion26 Apr 2023
Why it stopped: The study did not progress to full completion due to an unanticipated prolonged medical leave of absence of the Principal Investigator. This extended interruption resulted in early termination before completion of all planned activities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Julianna Nemeth, Ohio State University Comprehensive Cancer Center
- Investigators
- Julianna Nemeth, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754215
- Sponsor's protocol ID
- OSU-17281
- Other IDs
- NCI-2019-02248, K07CA216321
- Status last verified
- May 2026
- First submitted
- 17 Dec 2024
- Last updated
- 20 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Contextually Tailored and Optimized Smoking Cessation Intervention for Homeless Youth
- ClinicalTrials.gov ID
- NCT06754215
- Acronym / sponsor ID
- OSU-17281
- Conditions
- Cigarette Smoking-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study did not progress to full completion due to an unanticipated prolonged medical leave of absence of the Principal Investigator. This extended interruption resulted in early termination before completion of all planned activities.
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 31 Dec 2024 (actual)
- Results
- Posted 20 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial develops a contextually tailored and optimized smoking cessation intervention and studies smoking motivations and motivations to quit smoking in homeless youth. Identifying motivations for smoking and motivations to quit smoking may help researchers build a program to help homeless young people quit smoking cigarettes if desired.
Detailed description
PRIMARY OBJECTIVES:
- Establish a theoretical framework for cessation among homeless youth incorporating phase-specific capabilities and opportunities impacting motivation to engage in cessation. (Multiphase Optimization STrategy [MOST] Step 1) II. Guided by the theoretical framework for cessation among homeless youth, identify a set of cessation intervention components and assess their implementation feasibility. (MOST Step 2)
OUTLINE:
MOST STEP Ia: Participants attend a semi-structured interview over 60 minutes to help establish theoretical model of contextually tailored smoking cessation for homeless youth.
MOST STEP Ib: Participants complete a survey to help establish theoretical model of contextually tailored smoking cessation for homeless youth.
MOST STEP II (FOCUS GROUPS): Participants attend focus groups to help identify a set of cessation intervention components for homeless youth and determine component acceptability and feasibility.
MOST STEP II (FEASIBILITY STUDY): Intervention components are identified and selected from Focus Groups. Participants take part in a study to assess these components for feasibility in implementing in coordination with homeless youth services, as well as determining main effect estimates for future studies.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MOST STEP Ia (interview) | Experimental | Other: InterviewParticipants attend a semi-structured interview over 60 minutes to help establish theoretical model of contextually tailored smoking cessation for homeless youth. |
| MOST STEP Ib (survey) | Experimental | Other: Survey AdministrationParticipants complete a survey to help establish theoretical model of contextually tailored smoking cessation for homeless youth. |
| MOST STEP II (feasibility study) | Experimental | Behavioral: Smoking Cessation InterventionIntervention components are identified and selected from Focus Groups. Participants take part in a study to assess these components for feasibility in implementing in coordination with homeless youth services, as well as determining main effect estimates for future studies. |
| MOST STEP II (focus groups) | Experimental | Behavioral: Focus GroupParticipants attend focus groups to help identify a set of cessation intervention components for homeless youth and determine component acceptability and feasibility. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Youth who report having smoked some or every day in the past week.
- Youth who meet criteria for homelessness defined by the 2002 McKinney-Vento Act including those who lack a fixed, regular, and adequate nighttime residence; live in a welfare hotel, or place without regular sleeping accommodations; or live in a shared residence with other persons due to the loss of one's housing or economic hardship.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus GroupParticipate in focus group | Behavioural | MOST STEP II (focus groups) |
| InterviewParticipate in semi-structured interview | Other | MOST STEP Ia (interview) |
| Smoking Cessation InterventionAlso: Smoking and Tobacco Use Cessation InterventionsParticipate in feasibility study of intervention components | Behavioural | MOST STEP II (feasibility study) |
| Survey AdministrationComplete survey | Other | MOST STEP Ib (survey) |
Primary outcome
Youth's Psychological and Physical Capacity
Time frame: 60 minute semi-structured interview
Factors associated with participant's psychological and physical capacity which have prompted them to smoke in the past were captured during semi-structured interviews. In-person interviews followed a semi-structured interview guide. Questions were grounded in the Capability-Opportunity-Motivation for Behavior model, a theoretical framework that describes how intersecting psychosocial and environmental factors influence behavior. Questions were designed to elicit data on factors influencing tobacco use at a specific moment in time (participants' "last smoke") with the intent to optimize supportive cessation interventions for this population.
Youth's Physical and Social Factors
Time frame: Approximately 90 minute interview
Coping with homelessness was assessed using the Brief COPE to examine strategies used for coping or regulating cognition in response to stressors; participants were specifically asked to focus on their housing situation. This measure includes 28 items combined to form 14 subscales. Scores on each subscale range from 2 to 8 with higher scores indicating greater use of the strategy.
Motivation to Quit
Time frame: Approximately 90 minute interview
Interest in quitting in the next 30 days is an exemplar Phase-Based Model (PBM) for Cessation Research motivation phase treatment outcome measure. Participants reported if and when they planned to quit, derived from, "Do you plan to quit for good?" and "When do you plan to quit for good? In the next (7 days, 30 days, 6 months, year, more than a year from now)."
Past Quit Attempts
Time frame: Approximately 90 minute interview
Number of past year quit attempts: a proxy for past willingness to quit. Participants reported the number of quit attempts in the past year: "In the past 12 months, how many times have you quit smoking for at least 24 hours in a serious attempt to quit?"
Confidence in Ability to Quit in Next 6 Months
Time frame: Approximately 90 minute interview
Confidence in ability to quit in the next 6 months was measured with: "If you did try quitting smoking altogether in the next 6 months, how likely do you think you would be to succeed - not at all, a little likely, somewhat likely or very likely?"
Motivations for Smoking
Time frame: Approximately 90 minute interview
The Tobacco Motives Inventory was used; 15 questions, each scored on a 5-point Likert scale, were combined into four sub-scales: social motives, self enhancement motives, boredom relief motives, and affect regulation motives. Higher scores on each sub-scale indicate a higher motivation to smoke. Social motives: Sum of 4 items, scores range from 4 to 20 Self enhancement motives: Sum of 4 items, scores range from 4 to 20 Boredom relief motives: Sum of 2 items, scores range from 2 to 10 Affect regulation motives: Sum of 5 items, scores range from 5 to 25
Rewards From Quitting Smoking
Time frame: Approximately 90 minute interview
We measured 15 different rewards from smoking: "What are the benefits of smoking to you? Check all that apply"
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The JameslineLink provided by the sponsor.
Related trials for Cigarette Smoking-Related Carcinoma
RecruitingEarly Phase 1
Sensory Tests of Cigarettes for Identification of Flavors in Current Daily Smoking Adults
Cigarette Smoking-Related Carcinoma
Not yet recruiting
A Smartphone Application (QuitBot) for the Improvement of Smoking Cessation Among American Indians and Alaska Natives, NAITIVE Trial
Cigarette Smoking-Related Carcinoma
RecruitingPhase 3
Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program
Cigarette Smoking-Related Carcinoma
RecruitingPhase 4
Nicotine Replacement Therapy, Counseling, Varenicline, and Bupropion for Smoking Cessation, the PISCES I Trial
Cigarette Smoking-Related Carcinoma
Active, not recruiting
Text Message and Mail Delivery of Tailored Educational Materials to Improve Access to Resources for Smoking Cessation of Menthol Tobacco Cigarettes
Cigarette Smoking-Related Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julianna Nemeth principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focus Group, Interview and Smoking Cessation Intervention in people with Cigarette Smoking-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center 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 2 inclusion and 0 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: stopped early, as of the sponsor's last update on 20 Aug 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?
Yes. Results are posted in the registry (first posted 20 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Youth's Psychological and Physical Capacity (time frame: 60 minute semi-structured interview). The study lists 7 primary outcomes in all. 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 20 Aug 2026.