Tobacco SmokingNCT05471284
Recruitment Messages for Current Smokers Recently Diagnosed With Cancer
A study testing Proximal, Distal and Cost in people with Tobacco Smoking and Health Behavior, run by University of Oklahoma at 1 site in United States.
Trial summary
The objective of this study was to conduct a pilot factorial randomized trial to identify the message frames that are most effective in promoting participation in a tobacco treatment trial for current smokers recently diagnosed with cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking, Health Behavior
- What is being tested?
- Proximal, Distal and Cost
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2019to 2 Apr 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Speak and understand English
- A recent cancer diagnosis (within the past 24 months)
- 18 years or older
- Report any cigarette use within the past 30 days
Who cannot join
- Do not speak or understand English
- Have not been diagnosed with cancer within the past 24 months
- Below the age of 18
- Does not report any cigarette use within the past 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multimethod Evaluation of Tobacco Treatment Trial Recruitment Messages for Current Smokers Recently Diagnosed With Cancer: Pilot Factorial Randomized Controlled Trial
The objective of this study was to conduct a pilot factorial randomized trial to identify the message frames that are most effective in promoting participation in a tobacco treatment trial for current smokers recently diagnosed with cancer. To do so, we used a multimethod approach to evaluate 3 different message frames across evaluation, effectiveness, and outcome measures. We combine findings from a message design experiment with textual analytic software to provide a holistic understanding of how message frames may or may not differentially affect tobacco treatment trial participation within the context of a cancer diagnosis.
Read the detailed description
Background: A cancer diagnosis can catalyze motivation to quit smoking. Tobacco treatment trials offer cessation resources but have low accrual rates. Digital outreach may improve accrual, but knowledge of how best to recruit smokers with recent diagnoses is limited.
Objective: This study aims to identify the message frames that were most effective in promoting intent to talk to a physician about participating in a tobacco treatment trial for smokers recently diagnosed with cancer.
Methods: From February to April 2019, current smokers diagnosed within the past 24 months were recruited from a national web-based panel for a multimethod pilot randomized trial (N=99). Participants were randomized to a 2×3 plus control factorial design that tested 3 unique message frames: proximal versus distal threats of smoking, costs of continued smoking versus benefits of quitting, and gains of participating versus losses of not participating in a tobacco treatment trial.
- Conditions
- Tobacco Smoking, Health Behavior
- Being tested
- Proximal, Distal, Cost, Benefit, Loss
- Keywords
- Cancer, Digital outreach, Multimethod randomized trial, Factorial Design, Message Frames, Tobacco use, Smoker enrollment rates
- Medical subject headings
- Tobacco Smoking, Health Behavior, Neoplasms, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProximalBehavioural
The first factor tested framing of the near, proximal threat of continued smoking.
DistalBehavioural
The first factor tested framing of the long-term, distal threat of continued smoking.
CostBehavioural
Cost framework measures the response efficacy to quitting smoking by displaying costs of continued smoking.
BenefitBehavioural
Benefit framework measures the response efficacy to quitting smoking by displaying benefits of quitting.
LossBehavioural
The third factor tested framing of the response efficacy of participating in a cessation study by utilizing loss of not participating in a smoking cessation.
GainBehavioural
The third factor tested framing of the response efficacy of participating in a cessation study by utilizing gain of participating in a smoking cessation.
ControlBehavioural
Does not include any of the three message factors.
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | The control condition was a kernel message that included study information present in all conditions but did not include any of the message factors. Receives: Behavioral: Control |
| Proximal x Cost x Loss | Experimental | Message frame: proximal threats of smoking, cost of continued smoking, and loss of not participating in a tobacco treatment trial. Receives: Behavioral: Proximal; Behavioral: Cost; Behavioral: Loss |
| Proximal x Cost x Gain | Experimental | Message frame: proximal threats of smoking, cost of continued smoking, and gain of participating in a tobacco treatment trial. Receives: Behavioral: Proximal; Behavioral: Cost; Behavioral: Gain |
| Proximal x Benefit x Gain | Experimental | Message frame: proximal threats of smoking, benefits of quitting, and gain of participating in a tobacco treatment trial. Receives: Behavioral: Proximal; Behavioral: Benefit; Behavioral: Gain |
| Proximal x Benefit x Loss | Experimental | Message frame: proximal threats of smoking, benefits of quitting, and loss of not participating in a tobacco treatment trial. Receives: Behavioral: Proximal; Behavioral: Benefit; Behavioral: Loss |
| Distal x Cost x Gain | Experimental | Message frame: distal threats of smoking, cost of continued smoking, and gain of participating in a tobacco treatment trial. Receives: Behavioral: Distal; Behavioral: Cost; Behavioral: Gain |
| Distal x Cost x Loss | Experimental | Message frame: distal threats of smoking, cost of continued smoking, and loss of not participating in a tobacco treatment trial. Receives: Behavioral: Distal; Behavioral: Cost; Behavioral: Loss |
| Distal x Benefit x Loss | Experimental | Message frame: distal threats of smoking, benefits of quitting, and loss of not participating in a tobacco treatment trial. Receives: Behavioral: Distal; Behavioral: Benefit; Behavioral: Loss |
| Distal x Benefit x Gain | Experimental | Message frame: distal threats of smoking, benefits of quitting, and gain of participating in a tobacco treatment trial. Receives: Behavioral: Distal; Behavioral: Benefit; Behavioral: Gain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in intent to talk to a physician about participating in a smoking cessation study between factors.
The main effect within each message factor level was examined using ANOVA and compared with the control condition.
Measured: Within 30 minutes
Secondary outcomes (1)
Predictors of intent to talk to a physician about participating in a smoking cessation study.
Other message evaluation and effectiveness measures were collected and explored in a multivariable model predicting intent to talk to a physician.
Measured: Within 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start11 Feb 2019
- Primary completion1 Apr 2019
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts University, Massachusetts General Hospital, Memorial Sloan Kettering Cancer Center
- Responsible party
- Sponsor
- Investigators
- Jordan Neil, Ph.D., Principal investigator, TSET Health Promotion Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471284
- Sponsor's protocol ID
- 2018P002035
- Status last verified
- Jul 2022
- First submitted
- 13 Jul 2022
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Neil JM, Senecal C, Ballini L, Chang Y, Goshe B, Flores E, Ostroff JS, Park ER. A Multimethod Evaluation of Tobacco Treatment Trial Recruitment Messages for Current Smokers Recently Diagnosed With Cancer: Pilot Factorial Randomized Controlled Trial. JMIR Cancer. 2022 Aug 24;8(3):e37526. doi: 10.2196/37526.
PubMed 36001378
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimethod Evaluation of Tobacco Treatment Trial Recruitment Messages for Current Smokers Recently Diagnosed With Cancer: Pilot Factorial Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05471284
- Acronym / sponsor ID
- 2018P002035
- Conditions
- Tobacco Smoking, Health Behavior
- Keywords
- Cancer, Digital outreach, Multimethod randomized trial, Factorial Design, Message Frames, Tobacco use, Smoker enrollment rates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Tufts University, Massachusetts General Hospital, Memorial Sloan Kettering Cancer Center
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 22 Jul 2022 (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 objective of this study was to conduct a pilot factorial randomized trial to identify the message frames that are most effective in promoting participation in a tobacco treatment trial for current smokers recently diagnosed with cancer. To do so, we used a multimethod approach to evaluate 3 different message frames across evaluation, effectiveness, and outcome measures. We combine findings from a message design experiment with textual analytic software to provide a holistic understanding of how message frames may or may not differentially affect tobacco treatment trial participation within the context of a cancer diagnosis.
Detailed description
Background: A cancer diagnosis can catalyze motivation to quit smoking. Tobacco treatment trials offer cessation resources but have low accrual rates. Digital outreach may improve accrual, but knowledge of how best to recruit smokers with recent diagnoses is limited.
Objective: This study aims to identify the message frames that were most effective in promoting intent to talk to a physician about participating in a tobacco treatment trial for smokers recently diagnosed with cancer.
Methods: From February to April 2019, current smokers diagnosed within the past 24 months were recruited from a national web-based panel for a multimethod pilot randomized trial (N=99). Participants were randomized to a 2×3 plus control factorial design that tested 3 unique message frames: proximal versus distal threats of smoking, costs of continued smoking versus benefits of quitting, and gains of participating versus losses of not participating in a tobacco treatment trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Behavioral: ControlThe control condition was a kernel message that included study information present in all conditions but did not include any of the message factors. |
| Proximal x Cost x Loss | Experimental | Behavioral: Proximal, Behavioral: Cost, Behavioral: LossMessage frame: proximal threats of smoking, cost of continued smoking, and loss of not participating in a tobacco treatment trial. |
| Proximal x Cost x Gain | Experimental | Behavioral: Proximal, Behavioral: Cost, Behavioral: GainMessage frame: proximal threats of smoking, cost of continued smoking, and gain of participating in a tobacco treatment trial. |
| Proximal x Benefit x Gain | Experimental | Behavioral: Proximal, Behavioral: Benefit, Behavioral: GainMessage frame: proximal threats of smoking, benefits of quitting, and gain of participating in a tobacco treatment trial. |
| Proximal x Benefit x Loss | Experimental | Behavioral: Proximal, Behavioral: Benefit, Behavioral: LossMessage frame: proximal threats of smoking, benefits of quitting, and loss of not participating in a tobacco treatment trial. |
| Distal x Cost x Gain | Experimental | Behavioral: Distal, Behavioral: Cost, Behavioral: GainMessage frame: distal threats of smoking, cost of continued smoking, and gain of participating in a tobacco treatment trial. |
| Distal x Cost x Loss | Experimental | Behavioral: Distal, Behavioral: Cost, Behavioral: LossMessage frame: distal threats of smoking, cost of continued smoking, and loss of not participating in a tobacco treatment trial. |
| Distal x Benefit x Loss | Experimental | Behavioral: Distal, Behavioral: Benefit, Behavioral: LossMessage frame: distal threats of smoking, benefits of quitting, and loss of not participating in a tobacco treatment trial. |
| Distal x Benefit x Gain | Experimental | Behavioral: Distal, Behavioral: Benefit, Behavioral: GainMessage frame: distal threats of smoking, benefits of quitting, and gain of participating in a tobacco treatment trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Speak and understand English
- A recent cancer diagnosis (within the past 24 months)
- 18 years or older
- Report any cigarette use within the past 30 days
Key exclusion criteria (4 listed)
- Do not speak or understand English
- Have not been diagnosed with cancer within the past 24 months
- Below the age of 18
- Does not report any cigarette use within the past 30 days
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 |
|---|---|---|
| ProximalThe first factor tested framing of the near, proximal threat of continued smoking. | Behavioural | Proximal x Benefit x Gain, Proximal x Benefit x Loss, Proximal x Cost x Gain, Proximal x Cost x Loss |
| DistalThe first factor tested framing of the long-term, distal threat of continued smoking. | Behavioural | Distal x Benefit x Gain, Distal x Benefit x Loss, Distal x Cost x Gain, Distal x Cost x Loss |
| CostCost framework measures the response efficacy to quitting smoking by displaying costs of continued smoking. | Behavioural | Distal x Cost x Gain, Distal x Cost x Loss, Proximal x Cost x Gain, Proximal x Cost x Loss |
| BenefitBenefit framework measures the response efficacy to quitting smoking by displaying benefits of quitting. | Behavioural | Distal x Benefit x Gain, Distal x Benefit x Loss, Proximal x Benefit x Gain, Proximal x Benefit x Loss |
| LossThe third factor tested framing of the response efficacy of participating in a cessation study by utilizing loss of not participating in a smoking cessation. | Behavioural | Distal x Benefit x Loss, Distal x Cost x Loss, Proximal x Benefit x Loss, Proximal x Cost x Loss |
| GainThe third factor tested framing of the response efficacy of participating in a cessation study by utilizing gain of participating in a smoking cessation. | Behavioural | Distal x Benefit x Gain, Distal x Cost x Gain, Proximal x Benefit x Gain, Proximal x Cost x Gain |
| ControlDoes not include any of the three message factors. | Behavioural | Control |
Primary outcome
Difference in intent to talk to a physician about participating in a smoking cessation study between factors.
Time frame: Within 30 minutes
The main effect within each message factor level was examined using ANOVA and compared with the control condition.
1 secondary outcome
Predictors of intent to talk to a physician about participating in a smoking cessation study.
Time frame: Within 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Derived from this study: PubMed 36001378Neil JM, Senecal C, Ballini L, Chang Y, Goshe B, Flores E, Ostroff JS, Park ER. A Multimethod Evaluation of Tobacco Treatment Trial Recruitment Messages for Current Smokers Recently Diagnosed With Cancer: Pilot Factorial Randomized Controlled Trial. JMIR Cancer. 2022 Aug 24;8(3):e37526. doi: 10.2196/37526.
- Individual participant dataSharing planned: No
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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.
Jordan Neil, Ph.D. principal investigator
TSET Health Promotion Research 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 Proximal, Distal and Cost in people with Tobacco Smoking and Health Behavior, run by University of Oklahoma 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 22 Jul 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in intent to talk to a physician about participating in a smoking cessation study between factors. (time frame: Within 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05471284, which also lists 1 linked publication.
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 22 Jul 2022.