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This is the third study in a series of 3 studies to develop a smartphone app to support nondaily smokers in quitting smoking, as funded by the American Cancer Society grant #RSG CPPB - 130323 (project dates: 07/01/2017 - 6/30/2021). Study 1 (2017P001106) demonstrated feasibility and acceptability when smokers were onboarded in person. Study 2 (2018P002699) demonstrated feasibility and acceptability when smokers were onboarded remotely, nationwide. The present study is Study 3. It is a 3-group proof-of-concept RCT, in which we seek to test if our app (i.e., Version 3 of our developed smartphone app, called 'Smiling instead of Smoking' (SiS)) is superior to treatment as usual (i.e., TAU) and superior to a control app (i.e., the National Cancer Institute's smartphone app "QuitGuide" (QG).
This is a nation-wide proof-of-concept randomized controlled trial conducted entirely remotely. Participation will last 6 months and entails:
The Aims of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smiling Instead of Smoking (SiS) app | Experimental | Participants will be onboarded (remotely) to the smartphone app "Smiling instead of Smoking" (SiS), and will be asked to use it for 7 weeks while they quit smoking. |
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| QuitGuide (QG) app | Active Comparator | Participants will be onboarded (remotely) to the smartphone app "QuitGuide" (QG), and will be asked to use it for 7 weeks while they quit smoking. |
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| Clearing the Air (CTA) brochure | Other | Participants will be onboarded (remotely) to the NCI brochure "Clearing the Air" (CTA), and will be asked to use it for 7 weeks while they quit smoking. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone app "Smiling instead of Smoking" (SiS) Version 3 | Behavioral | Participants will be onboarded to the smartphone app SiS and will be asked to use it for 7 weeks to support them in quitting smoking. |
| Measure | Description | Time Frame |
|---|---|---|
| End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ) | The Smoking Self-Efficacy Questionnaire (SEQ-12) (Etter, Bergman, Humair, & Perneger, 2000) is a two-dimensional 12-item self-report scale measuring a person's confidence in his or her ability to abstain from smoking when facing internal stimuli (e.g. feeling depressed) and external stimuli (e.g. being with smokers) on a 0-100 slider scale (i.e., 0=not at all confident that I can refrain; 100=extremely confident that I can refrain). Scale scores are created by mean scoring across items and range from 0 to 100. Higher scores indicate greater self-efficacy to abstain from smoking. | Up to 24 weeks post quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (baseline = week -1). |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported 30-day Point-prevalence Abstinence | Participants responded to the multiple choice question, "What is your current smoking status?" with answer options: "I smoke daily", "I smoke non-daily (and have smoked in the past 7 days)", "I smoke nondaily (but have NOT smoked in the past 7 days)", and "I do not smoke at all"). If participants reported that they did not smoke at all, they were asked: "Have you been abstinent during the past 30 days?" (yes/no). All participants who reported smoking daily or nondaily to the first question, or who reported not smoking at all but had smoking in the past 30 days, or those who left either of those questions unanswered were marked as NOT 30-day point prevalent smoking abstinent (not included in the abstinent count below). People who reported not smoking at all and being smoking-abstinent for the past 30 days were marked as 30-day point prevalent smoking abstinent (include in the abstinent count below). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bettina Hoeppner, Ph.D., M.S. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10946439 | Background | Etter JF, Bergman MM, Humair JP, Perneger TV. Development and validation of a scale measuring self-efficacy of current and former smokers. Addiction. 2000 Jun;95(6):901-13. doi: 10.1046/j.1360-0443.2000.9569017.x. | |
| 10245370 | Background | Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available. |
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no plan to share IPD
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One participant in each treatment arm decided against the study during the onboarding process and before starting any study procedures. These were excluded from analysis in a modified intent to treat approach for an enrolled and active sample of n=226.
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| ID | Title | Description |
|---|---|---|
| FG000 | SiS App Treatment | Participants were onboarded (remotely) to the smartphone app "Smiling instead of Smoking" (SiS) Version 3, and were asked to use it for 7 weeks while they quit smoking. |
| FG001 | QG App Treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Week 2 Survey |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 14, 2022 |
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3-group proof-of-concept RCT
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| Smartphone app "QuitGuide" (QG) | Behavioral | Participants will be onboarded to the NCI smartphone app QG and will be asked to use it for 7 weeks to support them in quitting smoking. |
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| Brochure "Clearing the Air" (CTA) | Behavioral | Participants will be onboarded to the brochure "Clearing the Air" and will be asked to use it for 7 weeks to support them in quitting smoking. |
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| Assessed at 2, 6, 12, and 24 weeks post-quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
| Self-reported Past Week Cigarette Change | If participants report having smoked in the past 7 days, they were asked to indicate how many cigarettes they smoked each day ("Last Monday:, Last Sunday:). Changes in cigarette consumption were calculated by subtracting the number of cigarettes smoked in the week leading up to the baseline assessment, as measured in the baseline survey, from the number of cigarettes smoked in the week leading up to the 2, 6, 12, and 24 week post-quit assessments, as assessed in these respective surveys. | Assessed at 2, 6, 12, and 24 weeks post-quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
| Satisfaction With Smoking Cessation Support | As measured using the Client Satisfaction Scale (CSQ-8) (Larsen, 1979), an 8 item multiple choice measure that will be used to assess participants' satisfaction with the smoking cessation support they receive (e.g., "How satisfied are you with the amount of help you received?"). Scores are summed across items and range from 8 to 32, with higher scores indicating greater satisfaction. | Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
| Time Spent Applying Content Brought up by the Apps/"Clearing the Air" | Measured using the following single item, "During this past week, how much time did you spend applying or contemplating the content of the SiS app/QG app/"Clearing the Air"?" [in minutes]. | Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
| Use of Smoking Cessation Strategies | Assessed using a study-specific, unpublished 8-item measure in which participants rated the extent to which they agreed or disagreed with statements about the smoking cessation support they received and the things they did while quitting (5-point Likert scale, 1=strongly disagree, 5=strongly agree, e.g., "I used [the assigned treatment] the way I was supposed to (in the days leading up to and following my quit attempt)." and "I avoided situations that would make me want to smoke."). The scores of the 8 items were averaged, so that scores could range from 1 to 5, where higher scores indicate stronger agreement with the use of a larger combination of smoking cessation strategies (i.e., a more positive outcome). | Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
| Perceived Impact of the Provided Materials on Quitting | Assessed using a study-specific, unpublished 17-item measure in which participants rated the extent to which they agreed or disagreed with statements about the helpfulness of their assigned app during the quitting process (e.g., "[the app]...gave me confidence that I can quit smoking.", "[the app]... made me feel that I knew the right steps to take to quit.", and "[the app] ...reminded me in crucial moments to stay quit."). Items were rated on 5-point Likert scales ranging from 1="strongly disagree" to 5="strongly agree". The scores of the 17 items were averaged, so that scores could range from 1 to 5, where higher scores indicate stronger agreement with perceived impact of the smoking cessation support their assigned app provided (i.e., a more positive outcome). | Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
| Appreciation | As measured using the Appreciation Scale, (Adler & Fagley, 2005) an 18-item scale assessing the degree to which one is appreciative. Ten of the items assess frequency of action (e.g., "I do things to remind myself to be thankful", using a 7-point Likert scale of: 1 = "More than once a day" to 7 = "Never"). The remaining eight items assess level of agreement with appreciative statements (e.g., "I feel that it is a miracle to be alive", using a 7-point Likert scale of: 1 = "Strongly agree" to 7 = "Strongly disagree"). Item scores were summed to a total score with a possible range from 18 to 126 where higher scores indicate greater appreciation. | Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
| Actual App Usage (SiS and QG Only) | Number of days participants used the assigned app during the prescribed period of app use (i.e., 7 weeks for both apps). App usage is passively recorded by the app, which time-stamps every interaction with the app. | Cumulative from week 0 to week 24 post-quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
| Self-reported App Usage, Weeks 3 to 6 Post-quit (SiS and QG Only) | This was assessed via self-reported estimates of app use. Participants were asked on how many days they used the app in weeks 4, 5, and 6 post-quit ("On how many days per week did you use the app?"), and for how many minutes per typical day they used the assigned app ("On the days you used the app, how many minutes per day did you interact with the app?"). The days per week were multiplied by the minutes per app-use-day for each week, then averaged across the three weeks. | From week 3 to week 6 post-quit. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
| Likability Rating of the App (SiS and QG Only) | Measured using the single item, "How much did you like using the smoking cessation app we asked you to use?" Participants respond on a 5-point Likert scale (1 = I strongly disliked using the app, 2 = I somewhat disliked using the app, 3 = I neither liked nor disliked using the app; 4 = I somewhat liked using the app, and 5 = I strongly liked using the app). | Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
| Satisfaction Rating of the Smoking Cessation Support (SiS and QG Only) | Measured using the single item, "How satisfied are you with the smoking cessation support this app provided you with?" Participants respond on a 5-point Likert scale (1 = very unsatisfied, 2 = somewhat dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = somewhat satisfied, 5 = very satisfied). | Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
| App Usability Ratings (SiS and QG Only) | As assessed via the System Usability Scale (SUS; Brooke, 1996), a ten-item attitude scale giving a global view of subjective assessments of usability, adapted to include language specific to the smoking app (e.g., "I found the smoking app unnecessarily complex" 5-point Likert: 1 = strongly disagree, 5 = strongly agree). Scale scores range from 0 to 100 with greater scores indicating a more favorable perception of usability of the app. | Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
| 15660674 | Background | Adler MG, Fagley NS. Appreciation: individual differences in finding value and meaning as a unique predictor of subjective well-being. J Pers. 2005 Feb;73(1):79-114. doi: 10.1111/j.1467-6494.2004.00305.x. |
| Background | Brooke J. SUS-A quick and dirty usability scale. Usability evaluation in industry. 1996;189(194):4-7. |
| 39814363 | Derived | Hoeppner BB, Siegel KR, Futter AE, Finley-Abboud D, Williamson AC, Kahler CW, Park ER, Hoeppner SS. Smoking Cessation Smartphone App for Nondaily Smoking With Telephone Onboarding: Proof-of-Concept Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Jan 15;13:e53971. doi: 10.2196/53971. |
| 36787172 | Derived | Hoeppner BB, Siegel KR, Dickerman SR, Todi AA, Kahler CW, Park ER, Hoeppner SS. Testing the Outcomes of a Smoking Cessation Smartphone App for Nondaily Smokers: Protocol for a Proof-of-concept Randomized Controlled Trial. JMIR Res Protoc. 2023 Feb 14;12:e40867. doi: 10.2196/40867. |
Participants were onboarded (remotely) to the National Cancer Institute's (NCI) smartphone app "QuitGuide" (QG), and were asked to use it for 7 weeks while they quit smoking.
| FG002 | CTA Pamphlet | Participants were onboarded (remotely) to the National Cancer Institute's (NCI) brochure "Clearing the Air" (CTA), and were asked to use it for 7 weeks while they quit smoking. |
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| Week 6 Survey |
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| 3-Month Follow-up Survey |
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| 6-Month Follow-up Survey |
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All randomized and starting study procedures (n=226; see Participant flow pre-assignment details). Some measures had missing data.
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| ID | Title | Description |
|---|---|---|
| BG000 | SiS App Treatment | Participants were onboarded (remotely) to the smartphone app "Smiling instead of Smoking" (SiS) Version 3, and were asked to use it for 7 weeks while they quit smoking. |
| BG001 | QG App Treatment | Participants were onboarded (remotely) to the National Cancer Institute's (NCI) smartphone app "QuitGuide" (QG), and were asked to use it for 7 weeks while they quit smoking. |
| BG002 | CTA Pamphlet | Participants were onboarded (remotely) to the National Cancer Institute's (NCI) brochure "Clearing the Air" (CTA), and were asked to use it for 7 weeks while they quit smoking. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Highest level of education completed | Data was collected via self-report in pre-specified categories. | Count of Participants | Participants |
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| Employment | Collected via self-report with pre-specified categories. | Count of Participants | Participants |
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| Household Income | Collected via self-report with pre-specified categories. | Count of Participants | Participants |
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| Rurality | Collected via self-report with pre-specified categories. | Count of Participants | Participants |
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| US region | Collected via self-report with pre-specified categories. | Count of Participants | Participants |
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| Number of days smoked in past 30 days | Some participants declined to answer this question. | Mean | Standard Deviation | number of days |
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| Cigarettes per smoking day | Some participants declined to answer this question. | Mean | Standard Deviation | cigarettes per day |
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| Fagerstrom Test for Nicotine Dependence, total score | The Fagerström Test for Nicotine Dependence is a standard instrument for assessing the intensity of physical addiction to nicotine. The test contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. In scoring the Fagerstrom Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. | One participant missed one or more items on the scale. | Median | Inter-Quartile Range | units on a scale |
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| Ever smoked daily? | Count of Participants | Participants |
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| Ever tried to quit smoking before | Collected via self-report with pre-specified categories. | Count of Participants | Participants |
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| Ever used electronic cigarettes | Collected via self-report with pre-specified categories. | Count of Participants | Participants |
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| Currently uses electronic cigarettes | Count of Participants | Participants |
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| CES-D total scores | The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item scale with Likert scales ranging from "rarely or none of the time (less than 1 day)" to "Most or all of the time (5-7 days)". The possible range of scores is zero to 60, with higher scores indicating greater depression severity. | Median | Inter-Quartile Range | units on a scale |
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| GAD-7 total scores | The Generalized Anxiety Disorder 7-item (GAD-7) scale is a easy to perform initial screening tool for generalized anxiety disorder. Items are score on 4-point Likert scales ranging from "Not at all" to "Nearly every day". GAD-7 total scores range from 0 to 21, with higher values indicating greater depression severity. | Mean | Standard Deviation | units on a scale |
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| GSES total scores | The General Self-Efficacy Scale (GSES) is a 10 item scale that is rated on 4-point Likert scales ranging from "Not at all true" to "Exactly true". Total scores range from 10 to 40, with higher scores indicating greater general self-efficacy. | Mean | Standard Deviation | units on a scale |
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| Anhedonia | The Snaith-Hamilton Pleasure Scale (SHAPS) is a 14-item scale for the assessment of hedonic tone. Each item has four possible responses: strongly disagree, disagree, agree, or strongly agree. Either of the "disagree" responses score one point, and either of the "agree" responses score 0 points. Total scores can range from 0 to 14 with higher scores indicating greater anhedonia (i.e., smaller capacity to experience pleasure). Scores were recoded to indicate to indicate whether people had possible indication of anhedonia (scores > 2) or not. | Two participants (1 from SiS App Treatment, 1 from CTA Pamphlet) missed two or more items on the scale, and scale scores were not calculated for them. | Count of Participants | Participants |
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| Ever told they had a mental health or psychological condition | Asked as a Yes/No question. | Count of Participants | Participants |
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| SIMP - Extraversion | Extraversion was measured on a Single-Item Measures of Personality (SIMP) scale measured on 9-point Likert scale that ranged from "someone who is a reserved, private person, doesn't like to draw attention to themselves and can be shy around strangers" (=1) to "someone who is talkative, outgoing, is comfortable around people, but could be noisy and attention seeking" (=9) | Mean | Standard Deviation | units on a scale |
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| SIMP - Agreeableness | Agreeableness was measured on a Single-Item Measures of Personality (SIMP) scale measured on 9-point Likert scale that ranged from "someone who is forthright, tends to be critical and find fault with others and doesn't suffer fools gladly" (=1) to "someone who is generally trusting and forgiving, is interested in people, but can be taken for granted and finds it difficult to say no" (=9) | Mean | Standard Deviation | units on a scale |
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| SIMP - Emotional stability | Emotional stability was measured on a Single-Item Measures of Personality (SIMP) scale measured on 9-point Likert scale that ranged from "someone who is sensitive and excitable, and can be tense" (=1) to "someone who is relaxed, unemotional, rarely gets irritated and seldom feels blue" (=9) | Mean | Standard Deviation | units on a scale |
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| SIMP - Conscientiousness | Conscientisousness was measured on a Single-Item Measures of Personality (SIMP) scale measured on 9-point Likert scale that ranged from "someone who doesn't necessarily work on a schedule, tends to be flexible, but disorganised and often forgets to put things back in their proper place" (=1) to "someone who likes to plan things, likes to tidy up, pays attention to details, but can be rigid or inflexible" (=9) | Mean | Standard Deviation | units on a scale |
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| SIMP - Openness | Openness was measured on a Single-Item Measures of Personality (SIMP) scale measured on 9-point Likert scale that ranged from "someone who spends time reflecting on things, has an active imagination and likes to think of new ways of doing things, but may lack pragmatism" (=1) to "someone who is a practical person who is not interested in abstract ideas, prefers work that is routine and has few artistic interests" (=9) | Mean | Standard Deviation | units on a scale |
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| Any alcohol in the past 30 days | Asked as a Yes/No question | Count of Participants | Participants |
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| Any weeks of exceeding the drinking guidelines in the past 30 days | Using part of the the National Institute on Alcohol Abuse and Alcoholism (NIAAA) guidelines: For men, consuming more than 14 drinks per week For women, consuming more than 7 drinks per week | Count of Participants | Participants |
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| Any binge drinking in the past 30 days | Using the definition of the Substance Abuse and Mental Health Services Administration (SAMHSA), which conducts the annual National Survey on Drug Use and Health (NSDUH), which defines binge drinking as 5 or more alcoholic drinks for males or 4 or more alcoholic drinks for females on the same occasion (i.e., at the same time or within a couple of hours of each other) on at least 1 day in the past month. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ) | The Smoking Self-Efficacy Questionnaire (SEQ-12) (Etter, Bergman, Humair, & Perneger, 2000) is a two-dimensional 12-item self-report scale measuring a person's confidence in his or her ability to abstain from smoking when facing internal stimuli (e.g. feeling depressed) and external stimuli (e.g. being with smokers) on a 0-100 slider scale (i.e., 0=not at all confident that I can refrain; 100=extremely confident that I can refrain). Scale scores are created by mean scoring across items and range from 0 to 100. Higher scores indicate greater self-efficacy to abstain from smoking. | Some participants had missing data at various assessment time-points, but all enrolled participants provided data for at least one assessment. | Posted | Mean | Standard Deviation | units on a scale | Up to 24 weeks post quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (baseline = week -1). |
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| Secondary | Self-reported 30-day Point-prevalence Abstinence | Participants responded to the multiple choice question, "What is your current smoking status?" with answer options: "I smoke daily", "I smoke non-daily (and have smoked in the past 7 days)", "I smoke nondaily (but have NOT smoked in the past 7 days)", and "I do not smoke at all"). If participants reported that they did not smoke at all, they were asked: "Have you been abstinent during the past 30 days?" (yes/no). All participants who reported smoking daily or nondaily to the first question, or who reported not smoking at all but had smoking in the past 30 days, or those who left either of those questions unanswered were marked as NOT 30-day point prevalent smoking abstinent (not included in the abstinent count below). People who reported not smoking at all and being smoking-abstinent for the past 30 days were marked as 30-day point prevalent smoking abstinent (include in the abstinent count below). | Participants with missing data were assumed to be smoking (i.e., not 30-day point-prevalent abstinent from smoking). | Posted | Count of Participants | Participants | Assessed at 2, 6, 12, and 24 weeks post-quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
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| Secondary | Self-reported Past Week Cigarette Change | If participants report having smoked in the past 7 days, they were asked to indicate how many cigarettes they smoked each day ("Last Monday:, Last Sunday:). Changes in cigarette consumption were calculated by subtracting the number of cigarettes smoked in the week leading up to the baseline assessment, as measured in the baseline survey, from the number of cigarettes smoked in the week leading up to the 2, 6, 12, and 24 week post-quit assessments, as assessed in these respective surveys. | All available survey data at each assessment was used; by week 2 post-quit several participants had missing data for that and all subsequent assessments (n=3 for the SiS app, n=2 for the QG app, and n=3 for the CTA pamphlet groups). | Posted | Median | Inter-Quartile Range | Change in weekly cigs since baseline | Assessed at 2, 6, 12, and 24 weeks post-quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
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| Secondary | Satisfaction With Smoking Cessation Support | As measured using the Client Satisfaction Scale (CSQ-8) (Larsen, 1979), an 8 item multiple choice measure that will be used to assess participants' satisfaction with the smoking cessation support they receive (e.g., "How satisfied are you with the amount of help you received?"). Scores are summed across items and range from 8 to 32, with higher scores indicating greater satisfaction. | Participants with missing data were excluded from analysis. | Posted | Mean | Standard Deviation | units on a scale | Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
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| Secondary | Time Spent Applying Content Brought up by the Apps/"Clearing the Air" | Measured using the following single item, "During this past week, how much time did you spend applying or contemplating the content of the SiS app/QG app/"Clearing the Air"?" [in minutes]. | Participants with missing data were excluded from analysis. | Posted | Median | Inter-Quartile Range | minutes per week | Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
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| Secondary | Use of Smoking Cessation Strategies | Assessed using a study-specific, unpublished 8-item measure in which participants rated the extent to which they agreed or disagreed with statements about the smoking cessation support they received and the things they did while quitting (5-point Likert scale, 1=strongly disagree, 5=strongly agree, e.g., "I used [the assigned treatment] the way I was supposed to (in the days leading up to and following my quit attempt)." and "I avoided situations that would make me want to smoke."). The scores of the 8 items were averaged, so that scores could range from 1 to 5, where higher scores indicate stronger agreement with the use of a larger combination of smoking cessation strategies (i.e., a more positive outcome). | Participants with missing data were excluded from analysis. | Posted | Mean | Standard Deviation | units on a scale | Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
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| Secondary | Perceived Impact of the Provided Materials on Quitting | Assessed using a study-specific, unpublished 17-item measure in which participants rated the extent to which they agreed or disagreed with statements about the helpfulness of their assigned app during the quitting process (e.g., "[the app]...gave me confidence that I can quit smoking.", "[the app]... made me feel that I knew the right steps to take to quit.", and "[the app] ...reminded me in crucial moments to stay quit."). Items were rated on 5-point Likert scales ranging from 1="strongly disagree" to 5="strongly agree". The scores of the 17 items were averaged, so that scores could range from 1 to 5, where higher scores indicate stronger agreement with perceived impact of the smoking cessation support their assigned app provided (i.e., a more positive outcome). | Participants with missing data were excluded from analysis. | Posted | Mean | Standard Deviation | units on a scale | Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
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| Secondary | Appreciation | As measured using the Appreciation Scale, (Adler & Fagley, 2005) an 18-item scale assessing the degree to which one is appreciative. Ten of the items assess frequency of action (e.g., "I do things to remind myself to be thankful", using a 7-point Likert scale of: 1 = "More than once a day" to 7 = "Never"). The remaining eight items assess level of agreement with appreciative statements (e.g., "I feel that it is a miracle to be alive", using a 7-point Likert scale of: 1 = "Strongly agree" to 7 = "Strongly disagree"). Item scores were summed to a total score with a possible range from 18 to 126 where higher scores indicate greater appreciation. | Participants with missing data were excluded from analysis. | Posted | Mean | Standard Deviation | units on a scale | Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
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| Secondary | Actual App Usage (SiS and QG Only) | Number of days participants used the assigned app during the prescribed period of app use (i.e., 7 weeks for both apps). App usage is passively recorded by the app, which time-stamps every interaction with the app. | All participants randomized to either of the app treatment groups (SiS or QG). | Posted | Median | Inter-Quartile Range | number of days of app use | Cumulative from week 0 to week 24 post-quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
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| Secondary | Self-reported App Usage, Weeks 3 to 6 Post-quit (SiS and QG Only) | This was assessed via self-reported estimates of app use. Participants were asked on how many days they used the app in weeks 4, 5, and 6 post-quit ("On how many days per week did you use the app?"), and for how many minutes per typical day they used the assigned app ("On the days you used the app, how many minutes per day did you interact with the app?"). The days per week were multiplied by the minutes per app-use-day for each week, then averaged across the three weeks. | Participants with missing data were excluded. | Posted | Median | Inter-Quartile Range | average minutes per week | From week 3 to week 6 post-quit. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
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| Secondary | Likability Rating of the App (SiS and QG Only) | Measured using the single item, "How much did you like using the smoking cessation app we asked you to use?" Participants respond on a 5-point Likert scale (1 = I strongly disliked using the app, 2 = I somewhat disliked using the app, 3 = I neither liked nor disliked using the app; 4 = I somewhat liked using the app, and 5 = I strongly liked using the app). | Participants with missing data were excluded from analysis. | Posted | Mean | Standard Deviation | units on a scale | Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
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| Secondary | Satisfaction Rating of the Smoking Cessation Support (SiS and QG Only) | Measured using the single item, "How satisfied are you with the smoking cessation support this app provided you with?" Participants respond on a 5-point Likert scale (1 = very unsatisfied, 2 = somewhat dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = somewhat satisfied, 5 = very satisfied). | Participants with missing data were excluded from analysis. | Posted | Mean | Standard Deviation | units on a scale | Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
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| Secondary | App Usability Ratings (SiS and QG Only) | As assessed via the System Usability Scale (SUS; Brooke, 1996), a ten-item attitude scale giving a global view of subjective assessments of usability, adapted to include language specific to the smoking app (e.g., "I found the smoking app unnecessarily complex" 5-point Likert: 1 = strongly disagree, 5 = strongly agree). Scale scores range from 0 to 100 with greater scores indicating a more favorable perception of usability of the app. | Participants who were randomized to the two app treatment conditions (SiS and QuitGuide) and who completed the week 6 survey only. | Posted | Mean | Standard Deviation | units on a scale | Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1). |
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Adverse event data could be reported during the entire period of a participant's study participation (i.e., up to 6 months).
Adverse events were not assessed systematically. However, they could be reported by spontaneous self-report by the participants at any point during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Smiling Instead of Smoking (SiS) App | Participants will be onboarded (remotely) to the smartphone app "Smiling instead of Smoking" (SiS), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "Smiling instead of Smoking" (SiS) Version 3: Participants will be onboarded to the smartphone app SiS and will be asked to use it for 7 weeks to support them in quitting smoking. | 0 | 80 | 0 | 80 | 0 | 80 |
| EG001 | QuitGuide (QG) App | Participants will be onboarded (remotely) to the smartphone app "QuitGuide" (QG), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "QuitGuide" (QG): Participants will be onboarded to the NCI smartphone app QG and will be asked to use it for 7 weeks to support them in quitting smoking. | 0 | 75 | 0 | 75 | 0 | 75 |
| EG002 | Clearing the Air (CTA) Brochure | Participants will be onboarded (remotely) to the NCI brochure "Clearing the Air" (CTA), and will be asked to use it for 7 weeks while they quit smoking. Brochure "Clearing the Air" (CTA): Participants will be onboarded to the brochure "Clearing the Air" and will be asked to use it for 7 weeks to support them in quitting smoking. | 0 | 71 | 0 | 71 | 0 | 71 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bettina B. Hoeppner, Ph.D., MS | Recovery Research Institute, Department of Psychiatry, Massachusetts General Hospital | 617-643-1988 | bhoeppner@mgh.harvard.edu |
| Aug 2, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 14, 2022 | Aug 2, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided
| Withdrawal by Subject |
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| Withdrawn by PI |
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| Lost to Follow-up |
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| Withdrawal by Subject |
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| Lost to Follow-up |
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| Lost to Follow-up |
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| Female |
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| Other |
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| Some college |
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| College degree or higher |
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| Declined to answer |
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| Part-time |
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| Unemployed |
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| Declined to answer |
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| $40,000 - 69,999 |
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| $70,000 - 99,999 |
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| $100,000 or more |
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| Declined to answer |
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| Suburban |
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| Rural |
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| Midwest |
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| South |
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| West |
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| No |
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| Declined to answer |
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| No |
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| No |
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| No |
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| No |
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| No |
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| No |
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| No |
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| No |
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| Week 2 post-quit |
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| Week 6 post-quit |
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| Week 12 post-quit (3-month follow-up) |
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| Week 24 post-quit (6-month follow-up) |
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Model-estimated difference for the pairwise group difference at week 6 post-quit (end-of-treatment).
| Superiority |
| This proof-of-concept RCT was powered to detect an effect size of d=0.50 between SiS3 and either of the two control groups. Using SAS PROC POWER, it was determined that a sample size of n=64 per group would be needed to detect this effect in a 2-sided t-test with p=.05. Assuming a retention rate of 85%, it was determined that one needed to enroll n=75 per group in order to retain n=64 by end of treatment. | Mixed Models Analysis | 0.0072 | We used hierarchical linear mixed models with maximum likelihood estimation of all available longitudinal data to handle missing data, then used a planned, pairwise comparison to test for end-of-treatment group differences. | Mean Difference (Final Values) | 8.7775 | 2-Sided | 95 | 2.4070 | 15.1480 | Model-estimated difference for the pairwise group difference at week 6 post-quit (end-of-treatment). | Superiority |
Participants were onboarded (remotely) to the National Cancer Institute's (NCI) smartphone app "QuitGuide" (QG), and were asked to use it for 7 weeks while they quit smoking. |
| OG002 | CTA Pamphlet | Participants were onboarded (remotely) to the National Cancer Institute's (NCI) brochure "Clearing the Air" (CTA), and were asked to use it for 7 weeks while they quit smoking. |
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| OG002 | CTA Pamphlet | Participants were onboarded (remotely) to the National Cancer Institute's (NCI) brochure "Clearing the Air" (CTA), and were asked to use it for 7 weeks while they quit smoking. |
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| OG002 | CTA Pamphlet | Participants were onboarded (remotely) to the National Cancer Institute's (NCI) brochure "Clearing the Air" (CTA), and were asked to use it for 7 weeks while they quit smoking. |
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| OG002 | CTA Pamphlet | Participants were onboarded (remotely) to the National Cancer Institute's (NCI) brochure "Clearing the Air" (CTA), and were asked to use it for 7 weeks while they quit smoking. |
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| CTA Pamphlet |
Participants were onboarded (remotely) to the National Cancer Institute's (NCI) brochure "Clearing the Air" (CTA), and were asked to use it for 7 weeks while they quit smoking. |
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