Tobacco-Related CarcinomaNCT04297332
Episodic Future Thinking and Future Thinking Priming for Smoking Cessation
A study testing Behavioral Intervention, Informational Intervention and Nicotine Replacement in people with Tobacco-Related Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This trial studies the main and interactive effects of episodic future thinking and future thinking priming tasks on helping participants to quit smoking. Episodic future thinking and future thinking priming tasks may decrease delay discounting rates and reduce relapse to smoking and help participants quit smoking. 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
- What is being tested?
- Behavioral Intervention, Informational Intervention and Nicotine Replacement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 28 Dec 2023
- 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
- Smoke >= 8 cigarettes daily
- Planning to quit in the next 14 days
- No regular use of other tobacco products
- Access to the internet
- In possession of a smartphone with text messaging capabilities
- In possession of an email address accessible at least every other day
Who cannot join
- Unable or unwilling to provide consent
- Unable to provide data to the research team after the quit date
- Current use of bupropion or varenicline
- Drinking >= 20 alcoholic drinks per week
- Use of drugs of abuse in the past 30 days
- Living in the same household as a participant already enrolled in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Promising Methods to Decrease Delay Discounting and Reduce Relapse to Smoking
This trial studies the main and interactive effects of episodic future thinking and future thinking priming tasks on helping participants to quit smoking. Episodic future thinking and future thinking priming tasks may decrease delay discounting rates and reduce relapse to smoking and help participants quit smoking.
Read the detailed description
PRIMARY OBJECTIVE:
- To quantify the main and interactive effects of the episodic future thinking (EFT) and future thinking priming (FTP) tasks on delay discounting rate, latency to relapse, and multiple abstinence and self-regulation measures among smokers (n=76) who call a busy Quitline to quit smoking.
OUTLINE: Participants are randomized to 1 of 4 arms.
ARM I: Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks.
ARM II: Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or control future thinking priming task once per week for 12 weeks, alternating every week between tasks.
ARM III: Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks.
ARM IV: Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or control future thinking priming tasks once per week for 12 weeks, alternating every week between tasks.
- Conditions
- Tobacco-Related Carcinoma
- Being tested
- Behavioral Intervention, Informational Intervention, Nicotine Replacement, Telephone-Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior Therapy
Complete active episodic thinking task
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior Therapy
Complete active future thinking priming task
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior Therapy
Complete control episodic future thinking task
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior Therapy
Complete control future thinking priming task
Informational InterventionOther
Provided with Forever Free relapse prevention booklet
Nicotine ReplacementDrug
Also called nicotine replacement therapy, NRT
Receive nicotine patches, gum, or lozenges
Telephone-Based InterventionOther
Receive coaching call
| Study group | Role | What they receive |
|---|---|---|
| Arm I (active EFT, active FTP) | Experimental | Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks. Receives: Behavioral: Behavioral Intervention; Other: Informational Intervention; Other: Telephone-Based Intervention |
| Arm II (active EFT, control FTP) | Experimental | Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or control future thinking priming task once per week for 12 weeks, alternating every week between tasks. Receives: Behavioral: Behavioral Intervention; Other: Informational Intervention; Drug: Nicotine Replacement; Other: Telephone-Based Intervention |
| Arm III (control EFT, active FTP) | Experimental | Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks. Receives: Behavioral: Behavioral Intervention; Other: Informational Intervention; Drug: Nicotine Replacement; Other: Telephone-Based Intervention |
| Arm IV (control EFT, control TFP) | Active comparator | Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or control future thinking priming tasks once per week for 12 weeks, alternating every week between tasks. Receives: Behavioral: Behavioral Intervention; Other: Informational Intervention; Drug: Nicotine Replacement; Other: Telephone-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Delay discounting rate
Assessed with the 5-Trial Adjusting Delay Discounting.
Measured: Baseline, and 4 and 12 weeks after quit date
Latency to relapse
Will be assessed with the Timeline Follow-Back procedure administered by telephone. Analyzed using generalized mixed models.
Measured: Baseline, assessed up to 12 weeks
Secondary outcomes (7)
Latency to first relapse
Defined as the number of days until first relapse (any smoking for seven consecutive days). Will be assessed with the Timeline Follow-Back procedure administered by telephone. Analyzed using generalized mixed models.
Measured: up to 12 weeks
Number of days abstinent
Will be evaluated by cox proportional-hazards survival model analyses.
Measured: Up to 12 weeks
7-day point prevalence abstinence rates
Will be evaluated by cox proportional-hazards survival model analyses.
Measured: At 4 and 12 weeks after quit date
Attentional, motor, and non-planning impulsiveness
Assessed with the Barratt Impulsiveness Scale.
Measured: Up to 12 weeks
Behavioral inhibition and behavioral activation
Assessed with the Behavioral Avoidance/Inhibition scales.
Measured: Up to 12 weeks
Self-control
Assessed with the Brief Self-Control Survey.
Measured: Up to 12 weeks
Ability to regulate behavior to achieve goals
Assessed with the Short Self-Regulation Questionnaire.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start1 Jan 2020
- Primary completion28 Dec 2023
- Study completion28 Dec 2023
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco-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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Sheffer, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297332
- Sponsor's protocol ID
- I 82819
- Other IDs
- NCI-2020-00697, I 82819
- Status last verified
- Feb 2024
- First submitted
- 28 Feb 2020
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promising Methods to Decrease Delay Discounting and Reduce Relapse to Smoking
- ClinicalTrials.gov ID
- NCT04297332
- Acronym / sponsor ID
- I 82819
- Conditions
- Tobacco-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 5 Mar 2020 (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.
This trial studies the main and interactive effects of episodic future thinking and future thinking priming tasks on helping participants to quit smoking. Episodic future thinking and future thinking priming tasks may decrease delay discounting rates and reduce relapse to smoking and help participants quit smoking.
Detailed description
PRIMARY OBJECTIVE:
- To quantify the main and interactive effects of the episodic future thinking (EFT) and future thinking priming (FTP) tasks on delay discounting rate, latency to relapse, and multiple abstinence and self-regulation measures among smokers (n=76) who call a busy Quitline to quit smoking.
OUTLINE: Participants are randomized to 1 of 4 arms.
ARM I: Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks.
ARM II: Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or control future thinking priming task once per week for 12 weeks, alternating every week between tasks.
ARM III: Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks.
ARM IV: Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or control future thinking priming tasks once per week for 12 weeks, alternating every week between tasks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I (active EFT, active FTP) | Experimental | Behavioral: Behavioral Intervention, Other: Informational Intervention, Other: Telephone-Based InterventionParticipants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks. |
| Arm II (active EFT, control FTP) | Experimental | Behavioral: Behavioral Intervention, Other: Informational Intervention, Drug: Nicotine Replacement, Other: Telephone-Based InterventionParticipants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or control future thinking priming task once per week for 12 weeks, alternating every week between tasks. |
| Arm III (control EFT, active FTP) | Experimental | Behavioral: Behavioral Intervention, Other: Informational Intervention, Drug: Nicotine Replacement, Other: Telephone-Based InterventionParticipants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks. |
| Arm IV (control EFT, control TFP) | Active comparator | Behavioral: Behavioral Intervention, Other: Informational Intervention, Drug: Nicotine Replacement, Other: Telephone-Based InterventionParticipants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or control future thinking priming tasks once per week for 12 weeks, alternating every week between tasks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Smoke >= 8 cigarettes daily
- Planning to quit in the next 14 days
- No regular use of other tobacco products
- Access to the internet
- In possession of a smartphone with text messaging capabilities
Key exclusion criteria (6 listed)
- Unable or unwilling to provide consent
- Unable to provide data to the research team after the quit date
- Current use of bupropion or varenicline
- Drinking >= 20 alcoholic drinks per week
- Use of drugs of abuse in 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 |
|---|---|---|
| Behavioral InterventionAlso: Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior TherapyComplete active episodic thinking task | Behavioural | Arm I (active EFT, active FTP), Arm II (active EFT, control FTP) |
| Behavioral InterventionAlso: Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior TherapyComplete active future thinking priming task | Behavioural | Arm I (active EFT, active FTP), Arm III (control EFT, active FTP) |
| Behavioral InterventionAlso: Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior TherapyComplete control episodic future thinking task | Behavioural | Arm III (control EFT, active FTP), Arm IV (control EFT, control TFP) |
| Behavioral InterventionAlso: Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior TherapyComplete control future thinking priming task | Behavioural | Arm II (active EFT, control FTP), Arm IV (control EFT, control TFP) |
| Informational InterventionProvided with Forever Free relapse prevention booklet | Other | Arm I (active EFT, active FTP), Arm II (active EFT, control FTP), Arm III (control EFT, active FTP), Arm IV (control EFT, control TFP) |
| Nicotine ReplacementAlso: nicotine replacement therapy, NRTReceive nicotine patches, gum, or lozenges | Drug | Arm II (active EFT, control FTP), Arm III (control EFT, active FTP), Arm IV (control EFT, control TFP) |
| Telephone-Based InterventionReceive coaching call | Other | Arm I (active EFT, active FTP), Arm II (active EFT, control FTP), Arm III (control EFT, active FTP), Arm IV (control EFT, control TFP) |
Primary outcome
Change in Delay discounting rate
Time frame: Baseline, and 4 and 12 weeks after quit date
Assessed with the 5-Trial Adjusting Delay Discounting.
Latency to relapse
Time frame: Baseline, assessed up to 12 weeks
Will be assessed with the Timeline Follow-Back procedure administered by telephone. Analyzed using generalized mixed models.
7 secondary outcomes
Latency to first relapse
Time frame: up to 12 weeks
Number of days abstinent
Time frame: Up to 12 weeks
7-day point prevalence abstinence rates
Time frame: At 4 and 12 weeks after quit date
Attentional, motor, and non-planning impulsiveness
Time frame: Up to 12 weeks
Behavioral inhibition and behavioral activation
Time frame: Up to 12 weeks
Self-control
Time frame: Up to 12 weeks
Ability to regulate behavior to achieve goals
Time frame: Up to 12 weeks
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
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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.
Christine Sheffer principal investigator
Roswell Park 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 Behavioral Intervention, Informational Intervention and Nicotine Replacement in people with Tobacco-Related Carcinoma, run by Roswell Park Cancer Institute 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 6 inclusion and 6 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 8 Feb 2024. 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?
The study was stopped early (reason given: low accrual). Results are not available in the source record.
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?
Change in Delay discounting rate (time frame: Baseline, and 4 and 12 weeks after quit date). The study lists 2 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 8 Feb 2024.