CancerNCT06484179
Enhancing Motivation to Quit Smoking Via Self-Help Intervention Targeted to Cancer Type
A study testing Targeted Self-Help in people with Cancer and Smoking, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this research study is assess feasibility and acceptability of a recently developed brief self-help intervention targeted by cancer type to increase motivation to quit smoking. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Targeted Self-Help
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2024to Jul 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who smoke and recently (i.e., within 6 months) received a diagnosis of breast, colorectal, gynecological, skin melanoma, or bladder cancer (n = 20 per cancer type). (Investigators will consider smokers individuals who report having smoked ≥1 cigarette in the past 30 days.)
- Able to read/write English;
- Able to give informed consent;
- Not currently enrolled in a smoking cessation program;
- Age ≥18 years old.
Who cannot join
- Male patients diagnosed with breast cancer will be excluded as lifetime risk for breast cancer in men is far below 1%
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
- Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Heather Anderson, 801-585-1704, Heather.anderson@hci.utah.edu
Ursula Martinez, PhD
About this study
Official title: Enhancing Motivation to Quit Smoking Via Self-Help Intervention Targeted to Cancer Type: A Pilot Randomized Control Trial (RCT)
The purpose of this research study is assess feasibility and acceptability of a recently developed brief self-help intervention targeted by cancer type to increase motivation to quit smoking.
- Being tested
- Targeted Self-Help, Usual Care
- Medical subject headings
- Neoplasms, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Self-HelpBehavioural
In addition to usual care participants will receive a self-help booklet specific for their cancer type. There are five booklets available, written at a 5-6th grade reading level and targeted by cancer type, that explain the connection between smoking and each cancer type, describe the benefits of quitting smoking after cancer, and address some of the barriers cancer patients face to quit smoking when fighting cancer. Each booklet also includes four testimonials inspired from conversations with patients.
Usual CareBehavioural
Participants will receive the standard care typically offered for smoking cessation.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Not described Receives: Behavioral: Usual Care |
| Usual Care + Targeted Self-Help Intervention | Experimental | Not described Receives: Behavioral: Targeted Self-Help |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Number of participants who consent to participate in the study
Measured: Baseline
Retention- Completion of 2-week follow-up
Number of participants who complete the 2-week follow-up assessment
Measured: 2 weeks post-randomization
Retention- Completion of 1 month follow-up
Number of participants who complete the 1 month follow-up assessment
Measured: 1 month post-randomization
Adherence- 2 weeks post-randomization
Number of participants who read the booklet 2 weeks post-randomization
Measured: 2 weeks post-randomization
Adherence- 1 month post-randomization
Number of participants who read the booklet 1 month post-randomization
Measured: 1 month post-randomization
Acceptability
Treatment satisfaction measured with 8 items adapted from the Client Satisfaction Questionnaire. Values between 8 and 32 with higher scores indicating higher satisfaction.
Measured: 2 weeks post-randomization, 1 month post-randomization
Secondary outcomes (4)
Motivation to quit smoking
Changes in motivation to quit smoking will be assessed using the Contemplation Ladder. This is a validated measure for the assessment of readiness to quit smoking on a scale from 0 to 10. Higher scores indicate greater motivation to quit smoking.
Measured: Baseline, 2 weeks post-randomization, 1 month post-randomization
Treatment Engagement defined by the number of participants who enroll with the state tobacco quitline
Engagement in smoking cessation services defined by enrollment with state tobacco quitline
Measured: 2 weeks post-randomization, 1 month post-randomization
Smoking Status
7-day point prevalence smoking abstinence (i.e., not smoking, not even a puff, in the past 7 days)
Measured: 2 weeks post-randomization, 1 month post-randomization]
Smoking Status
30-day point prevalence smoking abstinence (i.e., not smoking, not even a puff, in the past 30 days)
Measured: 2 weeks post-randomization, 1 month post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start28 Aug 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to (1) Usual Care or (2) Usual Care + targeted self-help intervention.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ursula Martinez, PhD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484179
- Sponsor's protocol ID
- HCI173619
- Other IDs
- K22CA276255-01
- Status last verified
- Nov 2025
- First submitted
- 18 Jun 2024
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Motivation to Quit Smoking Via Self-Help Intervention Targeted to Cancer Type: A Pilot Randomized Control Trial (RCT)
- ClinicalTrials.gov ID
- NCT06484179
- Acronym / sponsor ID
- HCI173619
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is assess feasibility and acceptability of a recently developed brief self-help intervention targeted by cancer type to increase motivation to quit smoking.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to (1) Usual Care or (2) Usual Care + targeted self-help intervention.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual Care |
| Usual Care + Targeted Self-Help Intervention | Experimental | Behavioral: Targeted Self-Help |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals who smoke and recently (i.e., within 6 months) received a diagnosis of breast, colorectal, gynecological, skin melanoma, or bladder cancer (n = 20 per cancer type). (Investigators will consider smokers individuals who report having smoked ≥1 cigarette in the past 30 days.)
- Able to read/write English;
- Able to give informed consent;
- Not currently enrolled in a smoking cessation program;
- Age ≥18 years old.
Key exclusion criteria (1 listed)
- Male patients diagnosed with breast cancer will be excluded as lifetime risk for breast cancer in men is far below 1%
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 |
|---|---|---|
| Targeted Self-HelpIn addition to usual care participants will receive a self-help booklet specific for their cancer type. There are five booklets available, written at a 5-6th grade reading level and targeted by cancer type, that explain the connection between smoking and each cancer type, describe the benefits of quitting smoking after cancer, and address some of the barriers cancer patients face to quit smoking when fighting cancer. Each booklet also includes four testimonials inspired from conversations with patients. | Behavioural | Usual Care + Targeted Self-Help Intervention |
| Usual CareParticipants will receive the standard care typically offered for smoking cessation. | Behavioural | Usual Care |
Primary outcome
Recruitment
Time frame: Baseline
Number of participants who consent to participate in the study
Retention- Completion of 2-week follow-up
Time frame: 2 weeks post-randomization
Number of participants who complete the 2-week follow-up assessment
Retention- Completion of 1 month follow-up
Time frame: 1 month post-randomization
Number of participants who complete the 1 month follow-up assessment
Adherence- 2 weeks post-randomization
Time frame: 2 weeks post-randomization
Number of participants who read the booklet 2 weeks post-randomization
Adherence- 1 month post-randomization
Time frame: 1 month post-randomization
Number of participants who read the booklet 1 month post-randomization
Acceptability
Time frame: 2 weeks post-randomization, 1 month post-randomization
Treatment satisfaction measured with 8 items adapted from the Client Satisfaction Questionnaire. Values between 8 and 32 with higher scores indicating higher satisfaction.
4 secondary outcomes
Motivation to quit smoking
Time frame: Baseline, 2 weeks post-randomization, 1 month post-randomization
Treatment Engagement defined by the number of participants who enroll with the state tobacco quitline
Time frame: 2 weeks post-randomization, 1 month post-randomization
Smoking Status
Time frame: 2 weeks post-randomization, 1 month post-randomization]
Smoking Status
Time frame: 2 weeks post-randomization, 1 month post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Ursula Martinez, PhD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Self-Help in people with Cancer and Smoking, run by University of Utah 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 5 inclusion and 1 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 26 Nov 2025. 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 Heather Anderson (801-585-1704, Heather.Anderson@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Baseline). The study lists 6 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 26 Nov 2025.