Cigarette Smoking-Related CarcinomaPhase 1NCT04502524
Website Smoking Cessation Intervention for the Promotion of Smoking Cessation in Low-Income Veterans
A Phase 1 study testing Smoking Cessation Intervention (New website), Health Education and Health Promotion and Education in people with Cigarette Smoking-Related Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This phase I trial studies how well a new electronic (e)-health smoking cessation program (called Vet Flexiquit) works in promoting smoking cessation in low-income veterans who may or may not be ready to 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
- Cigarette Smoking-Related Carcinoma
- What is being tested?
- Smoking Cessation Intervention (New website), Health Education and Health Promotion and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2021to 28 Jan 2022
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be a US veteran
- Participants must be low-income, as defined by falling below Veterans Health Administration (VHA) national income threshold for no-cost healthcare
- Participants must be a current smoker, averaging at least 5 cigarettes/day for the last 30 days
- Participants must have weekly internet access for the next 3 months
- Participants must self-report current use of a personal email address to receive the link to their assigned web site
- Participants must self-report being willing to complete all study activities
- Participants must be willing to receive study-related text messages
Who cannot join
- Currently taking part in any other smoking cessation treatment such as the nicotine patch, nicotine gum, Zyban, in-person counseling, telephone counseling, using a web-based or app-based cessation program
- Have recent (past 30 days) substance use disorder, suicidal ideation, or psychiatric hospitalization
- Previous participation in the treatment development stage of the new smoking cessation website program
- Prior use of the SmokefreeVET web site
- Member of the same household as another research participant
- Woman who is pregnant or breastfeeding, or planning to become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Bedford VA Research Corporation, Inc.
Bedford, Massachusetts, 01730
About this study
Official title: A Scalable e-Health Smoking Cessation Intervention for Socioeconomically Disadvantaged Veterans
This phase I trial studies how well a new electronic (e)-health smoking cessation program (called Vet Flexiquit) works in promoting smoking cessation in low-income veterans who may or may not be ready to quit smoking. The study will compare the new website smoking cessation program to the current standard care website smoking cessation program offered by the Veterans Administration (VA). Both website interventions will be accompanied by a text messaging program that includes: (1) motivational messages, and (2) reminders to use the assigned program. Both of the website interventions can help smokers quit or cut back on how much they smoke, thus dramatically reducing their chances of developing tobacco-related health conditions.
Read the detailed description
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants use the new website smoking cessation program, which provides values driven, mindfulness based coping skills and utilizes non-judgmental acceptance of uncomfortable internal states like cravings. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with handouts and available resources provided by the VA for continued support for smoking cessation.
ARM II: Participants use the VA standard of care website, which provides educational materials about cessation treatments, tools to cope with urges and relapse, how to stay motivated, and brief tips on coping with physical and mental health problems. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with a handout of available resources provided by the VA for continued support for smoking cessation.
After study randomization, participants are followed up at 1 and 3 months.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- Smoking Cessation Intervention (New website), Smoking Cessation Intervention (Standard of care website), Health Education, Health Promotion and Education, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Cessation Intervention (New website)Behavioural
Also called Smoking and Tobacco Use Cessation Interventions
Complete the new website smoking cessation program
Smoking Cessation Intervention (Standard of care website)Behavioural
Also called standard of care, standard therapy, best practice
Complete the standard of care website smoking cessation intervention
Health EducationBehavioural
Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.
Health Promotion and EducationOther
Receive motivational and reminder text messages
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (New website program, handout, text message) | Experimental | Participants complete the new website smoking cessation program which provides values driven, mindfulness based coping skills and utilizes non-judgmental acceptance of uncomfortable internal states like cravings. Participants will also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with all session handouts and available resources provided by the VA for continued support for smoking cessation. Receives: Behavioral: Smoking Cessation Intervention (New website); Behavioral: Health Education; Other: Health Promotion and Education; Other: Questionnaire Administration |
| Arm II (Standard care VA website, handout, text message) | Active comparator | Participants use the standard of care website, which provides educational materials about cessation treatments, tools to cope with urges and relapse, how to stay motivated, and brief tips on coping with physical and mental health problems. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with a handout of available resources provided by the VA for continued support for smoking cessation. Receives: Behavioral: Smoking Cessation Intervention (Standard of care website); Behavioral: Health Education; Other: Health Promotion and Education; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction With Assigned Treatment
Satisfaction ratings regarding the usefulness of specific components of the website program, user comments and suggestions for improvement, presented descriptively. Treatment satisfaction items are reported on a Likert-type scale, with response choices ranging from "not at all satisfied" to "very satisfied". Will dichotomize values at a threshold of "somewhat satisfied" or higher. We tested for differences between arms using a Fisher's Exact test.
Measured: At 3 months post-randomization
Number of Server-recorded Logins to Assigned Website
Will use negative binomial regression with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare treatment effects on the count outcome number of logins. There were no potential confounders to adjust for.
Measured: At 3 months
Duration of Website Use (Days Since First Login)
Will use negative binomial regression with adjustment for the stratification variable baseline readiness to quit (high versus low) to compare treatment groups on the secondary acceptability outcome of duration of site usage (number of days elapsed from first to last use). There were no confounders to adjust for.
Measured: At 3 months
Secondary outcomes (6)
Number of Quit Attempts
Will use a negative binomial model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare the count outcome number of quit attempts between arms. There were no confounders to address for.
Measured: At 3 months
Cotinine-confirmed, Self-reported Abstinence From Smoking
Will use a logistic regression model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare smoking abstinence between arms. There were no confounders to adjust for. Missing responses were considered as continued smokers.
Measured: In the 7 days prior to the 3-month follow up
Cotinine-confirmed, Self-reported Abstinence From Smoking
Will use a logistic regression model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare smoking abstinence between arms. There were no confounders to adjust for. Missing responses were considered continued smokers.
Measured: In the 30 days prior to the 3-month follow up
Self-reported Abstinence From All Nicotine and Tobacco Products (Except Nicotine Replacement Therapy)
Will use a logistic regression model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare smoking abstinence between arms. There were no confounders to adjust for. The missing responses were considered continued smokers.
Measured: In the 7 days prior to the 3-month follow up
Change in Readiness to Quit
Will be assessed by the Contemplation Ladder on a scale from 0 (no thought about quitting) to 10 (taking action to quit). Will calculate change score as follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variable and baseline readiness to quit (high versus low) to compare between study arms. There were no confounders to adjust for.
Measured: Baseline up to 3-month follow-up
Change in Acceptance of Smoking Triggers
Will be assessed by the Avoidance and Inflexibility Scale (AIS) on a scale ranging from 0 (never/not at all) to 4 (always/very much/extensively). Will calculate change score as follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variable and baseline readiness to quit (high versus low) to compare between study arms. There were no confounders to adjust for. This is the AIS Feelings score change.
Measured: Baseline up to 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start3 Feb 2021
- Primary completion28 Jan 2022
- Study completion28 Jan 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jaimee Heffner, Fred Hutchinson Cancer Center
- Investigators
- Jaimee Heffner, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502524
- Sponsor's protocol ID
- RG1007109
- Other IDs
- NCI-2020-05587, R21CA236980, 10097
- Status last verified
- Mar 2023
- First submitted
- 30 Jul 2020
- Last updated
- 7 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heffner JL, Kelly MM, Reilly ED, Reece SG, Claudio T, Serfozo E, Baker K, Watson NL, Karekla M. An Avatar-Led Web-Based and SMS Text Message Smoking Cessation Program for Socioeconomically Disadvantaged Veterans: Pilot Randomized Controlled Trial. JMIR Form Res. 2023 Apr 14;7:e44503. doi: 10.2196/44503.
PubMed 37058346
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Scalable e-Health Smoking Cessation Intervention for Socioeconomically Disadvantaged Veterans
- ClinicalTrials.gov ID
- NCT04502524
- Acronym / sponsor ID
- RG1007109
- Conditions
- Cigarette Smoking-Related Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 6 Aug 2020 (actual)
- Results
- Posted 7 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I trial studies how well a new electronic (e)-health smoking cessation program (called Vet Flexiquit) works in promoting smoking cessation in low-income veterans who may or may not be ready to quit smoking. The study will compare the new website smoking cessation program to the current standard care website smoking cessation program offered by the Veterans Administration (VA). Both website interventions will be accompanied by a text messaging program that includes: (1) motivational messages, and (2) reminders to use the assigned program. Both of the website interventions can help smokers quit or cut back on how much they smoke, thus dramatically reducing their chances of developing tobacco-related health conditions.
Detailed description
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants use the new website smoking cessation program, which provides values driven, mindfulness based coping skills and utilizes non-judgmental acceptance of uncomfortable internal states like cravings. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with handouts and available resources provided by the VA for continued support for smoking cessation.
ARM II: Participants use the VA standard of care website, which provides educational materials about cessation treatments, tools to cope with urges and relapse, how to stay motivated, and brief tips on coping with physical and mental health problems. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with a handout of available resources provided by the VA for continued support for smoking cessation.
After study randomization, participants are followed up at 1 and 3 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (New website program, handout, text message) | Experimental | Behavioral: Smoking Cessation Intervention (New website), Behavioral: Health Education, Other: Health Promotion and Education, Other: Questionnaire AdministrationParticipants complete the new website smoking cessation program which provides values driven, mindfulness based coping skills and utilizes non-judgmental acceptance of uncomfortable internal states like cravings. Participants will also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with all session handouts and available resources provided by the VA for continued support for smoking cessation. |
| Arm II (Standard care VA website, handout, text message) | Active comparator | Behavioral: Smoking Cessation Intervention (Standard of care website), Behavioral: Health Education, Other: Health Promotion and Education, Other: Questionnaire AdministrationParticipants use the standard of care website, which provides educational materials about cessation treatments, tools to cope with urges and relapse, how to stay motivated, and brief tips on coping with physical and mental health problems. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with a handout of available resources provided by the VA for continued support for smoking cessation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must be a US veteran
- Participants must be low-income, as defined by falling below Veterans Health Administration (VHA) national income threshold for no-cost healthcare
- Participants must be a current smoker, averaging at least 5 cigarettes/day for the last 30 days
- Participants must have weekly internet access for the next 3 months
- Participants must self-report current use of a personal email address to receive the link to their assigned web site
Key exclusion criteria (6 listed)
- Currently taking part in any other smoking cessation treatment such as the nicotine patch, nicotine gum, Zyban, in-person counseling, telephone counseling, using a web-based or app-based cessation program
- Have recent (past 30 days) substance use disorder, suicidal ideation, or psychiatric hospitalization
- Previous participation in the treatment development stage of the new smoking cessation website program
- Prior use of the SmokefreeVET web site
- Member of the same household as another research participant
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 |
|---|---|---|
| Smoking Cessation Intervention (New website)Also: Smoking and Tobacco Use Cessation InterventionsComplete the new website smoking cessation program | Behavioural | Arm I (New website program, handout, text message) |
| Smoking Cessation Intervention (Standard of care website)Also: standard of care, standard therapy, best practiceComplete the standard of care website smoking cessation intervention | Behavioural | Arm II (Standard care VA website, handout, text message) |
| Health EducationReceive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study. | Behavioural | Arm I (New website program, handout, text message), Arm II (Standard care VA website, handout, text message) |
| Health Promotion and EducationReceive motivational and reminder text messages | Other | Arm I (New website program, handout, text message), Arm II (Standard care VA website, handout, text message) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (New website program, handout, text message), Arm II (Standard care VA website, handout, text message) |
Primary outcome
Satisfaction With Assigned Treatment
Time frame: At 3 months post-randomization
Satisfaction ratings regarding the usefulness of specific components of the website program, user comments and suggestions for improvement, presented descriptively. Treatment satisfaction items are reported on a Likert-type scale, with response choices ranging from "not at all satisfied" to "very satisfied". Will dichotomize values at a threshold of "somewhat satisfied" or higher. We tested for differences between arms using a Fisher's Exact test.
Number of Server-recorded Logins to Assigned Website
Time frame: At 3 months
Will use negative binomial regression with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare treatment effects on the count outcome number of logins. There were no potential confounders to adjust for.
Duration of Website Use (Days Since First Login)
Time frame: At 3 months
Will use negative binomial regression with adjustment for the stratification variable baseline readiness to quit (high versus low) to compare treatment groups on the secondary acceptability outcome of duration of site usage (number of days elapsed from first to last use). There were no confounders to adjust for.
6 secondary outcomes
Number of Quit Attempts
Time frame: At 3 months
Cotinine-confirmed, Self-reported Abstinence From Smoking
Time frame: In the 7 days prior to the 3-month follow up
Cotinine-confirmed, Self-reported Abstinence From Smoking
Time frame: In the 30 days prior to the 3-month follow up
Self-reported Abstinence From All Nicotine and Tobacco Products (Except Nicotine Replacement Therapy)
Time frame: In the 7 days prior to the 3-month follow up
Change in Readiness to Quit
Time frame: Baseline up to 3-month follow-up
Change in Acceptance of Smoking Triggers
Time frame: Baseline up to 3-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37058346Heffner JL, Kelly MM, Reilly ED, Reece SG, Claudio T, Serfozo E, Baker K, Watson NL, Karekla M. An Avatar-Led Web-Based and SMS Text Message Smoking Cessation Program for Socioeconomically Disadvantaged Veterans: Pilot Randomized Controlled Trial. JMIR Form Res. 2023 Apr 14;7:e44503. doi: 10.2196/44503.
- 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.
Jaimee Heffner principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Smoking Cessation Intervention (New website), Health Education and Health Promotion and Education in people with Cigarette Smoking-Related Carcinoma, run by Fred Hutchinson 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 7 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: finished, as of the sponsor's last update on 7 Apr 2023. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2023). 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?
Satisfaction With Assigned Treatment (time frame: At 3 months post-randomization). The study lists 3 primary outcomes in all. 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 NCT04502524, 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 7 Apr 2023.