Efficacy of smartphone applications to help cancer patients quit smoking: Protocol of the Quit2Heal randomized controlled trial
Open accessAbstract
Cigarette smoking is highly prevalent among cancer patients in the United States (US), with up to half of cancer patients smoking at the time of their initial cancer diagnosis. However, evidence-based cessation programs are rarely implemented in oncology care, and smoking is not consistently treated in cancer treatment settings. Consequently, there is an urgent need for accessible and efficacious cessation treatments that are uniquely tailored to the needs of cancer patients. Here we describe the design and implementation of a randomized controlled trial (RCT) testing the efficacy of a smartphone app (Quit2Heal) versus a US Clinical Practice Guidelines-based app (QuitGuide) for smoking cessation among a planned sample of 422 cancer patients. Quit2Heal is designed to address cancer-related shame, stigma, depression, anxiety, and knowledge about the consequences of smoking/quitting. Quit2Heal is based on the principles of Acceptance and Commitment Therapy, a behavioral therapy that teaches skills for accepting cravings to smoke without smoking, values-driven motivation to quit, and preventing relapse. The primary aim of the RCT is to determine whether Quit2Heal has significantly higher self-reported 30-day point prevalence abstinence at 12 months relative to QuitGuide. The trial will also determine whether Quit2Heal's effect on cessation is (1) mediated by improvements in cancer-related shame, stigma, depression, anxiety, and knowledge about the consequences of smoking/quitting; and (2) moderated by baseline factors (e.g., cancer type, stage, time since diagnosis). If successful, Quit2Heal will offer a more efficacious, broadly scalable smoking cessation treatment that could be implemented alongside existing oncology care, thereby improving cancer outcomes. © 2023 Elsevier Inc.
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Claims the paper makes
42 of 68 cited sources checked · 12 supported · 0 flagged · accuracy not yet measured
- Premisecitation
Among US cancer patients at initial diagnosis, smoking prevalence ranges from 15% to 54%.
“Cigarette smoking is highly prevalent among cancer patients in the United States (US), with 15% to 54% of cancer patients reporting smoking at the time of their initial cancer diagnosis.1–3”
- Also stated in: § Abstract · hedged
“Cigarette smoking is highly prevalent among cancer patients in the United States (US), with up to half of cancer patients smoking at the time of their initial cancer diagnosis.”
Quote in the paperNot a substantial claim3 of 3 sources checked- cites [1] source
The Smoking Rates section (page not specified) reports smoking around diagnosis in 38.7% of lung cancer patients and 13.7% of colorectal cancer patients, supporting substantial smoking prevalence in these groups. It does not establish a 15%–54% range for US cancer patients generally; its figure near 54% refers to ever smoking, not smoking at diagnosis. (LLM, conf=0.87)
Experimental — accuracy not yet measured - cites [2] source
The Results (page unavailable) report that 50.6% of US cancer survivors smoked regularly before their diagnosis, which supports a prevalence figure within the claimed range. The paper does not report a 15%–54% range for smoking at initial diagnosis; the range's endpoints are not supported by this source. (LLM, conf=0.85)
Experimental — accuracy not yet measured - cites [3] source
The Results (page unavailable) report substantial cigarette-smoking prevalence after lung or head/neck cancer diagnosis, with a mean of 33.0%. They do not give a 15%–54% range at initial diagnosis, and the review’s findings do not cover all US cancer patients. (LLM, conf=0.86)
Experimental — accuracy not yet measured
- Also stated in: § Abstract · hedged
- Premisecitation
Up to 80% of cancer patients who smoke continue smoking after their diagnosis.
“Up to 80% of cancer patients who smoke continue to smoke after their diagnosis.4–6”
Quote in the paperSubstantial claim1 of 3 sources checked- cites [4] source
- cites [5] source
- cites [6] source
The Patient characteristics section reports smoking status near diagnosis, not whether patients continued smoking afterward. The Epidemiology section explicitly says the study had no follow-up smoking assessment. A search for the 80% continuation figure found no passage establishing it; page numbers were unavailable in our copy. (LLM, conf=0.78)
Experimental — accuracy not yet measured
- Premisecitation
In an observational study of 631 US cancer patients, 74% used mobile technologies regularly, including smartphones.
“a recent observational study among cancer patients in the US (N=631) reported that 74% of cancer patients used mobile technologies regularly, including smartphones.26”
Quote in the paperSubstantial claim1 of 1 sources checked- cites [26] source
- Premisecitation
Standard cessation approaches such as USCPG teach avoidance of cravings that trigger smoking.
“In contrast, standard approaches for cessation, such as the US Clinical Practice Guidelines (USCPG), teach avoidance of cravings that trigger smoking.43”
Quote in the paperSubstantial claim1 of 1 sources checked- cites [43] source
The guideline’s “Smoking cues and availability of cigarettes” section recommends avoiding temptation and trigger situations. It also recommends coping with smoking urges through distraction and changes in routine, but does not specifically teach avoiding the cravings themselves. (LLM, conf=0.85)
Experimental — accuracy not yet measured
- Premisecitation
Cancer patients in rural areas and those without access to cancer centers face accessibility inequities because cancer centers are mainly located in urban areas.
“In fact, there are tremendous accessibility inequities among cancer patients who live in rural areas and those who do not have access to cancer centers, as they are primarily located in urban areas.22”
Quote in the paperSubstantial claim1 of 1 sources checked- cites [22] source
The ‘An uneven landscape’ section reports that rural residents face barriers to screening and treatment, including fewer local facilities and specialists. It does not say that cancer centers are primarily located in urban areas or establish that their location causes the inequities described. (LLM, conf=0.86)
Experimental — accuracy not yet measured
- Premisecitation
ACT-based digital interventions, including smartphone apps for the general population, promote smoking cessation.
“Previous studies have demonstrated that ACT-based digital interventions, including smartphone apps for the general population, promote smoking cessation.40–42”
Quote in the paperSubstantial claim1 of 3 sources checked- cites [40] source
- cites [41] source
- cites [42] source
The ACT for smoking cessation section reports promising abstinence results from earlier studies of web-based ACT and an ACT smartphone app in general populations. But this paper’s own intervention was delivered face-to-face and by telephone, not through an app; its Primary outcome section found no significant difference in quitting at 12 months. It therefore supports the background finding, but not the implication that this study demonstrated the effectiveness of a digital intervention. (LLM, conf=0.86)
Experimental — accuracy not yet measured
- Premisecitation
Post-diagnosis smoking is associated with increased all-cause and cancer-related mortality.
“and all-cause and cancer-related mortality.12,13”
Quote in the paperSubstantial claim2 of 2 sources checked- cites [12] source
The Results (p. 2) associate smoking at diagnosis with worse ovarian-cancer survival. But the paper explicitly limits its analysis to ovarian-cancer mortality, censoring deaths from other causes (Results, p. 2), and says it had no information on smoking after diagnosis (Discussion, p. 2). It therefore does not establish the claimed association for post-diagnosis smoking or all-cause mortality. (LLM, conf=0.90)
Experimental — accuracy not yet measured - cites [13] source
The 'Effect of quitting smoking at diagnosis on disease progression and mortality' section associates continued smoking after early-stage lung cancer diagnosis with increased all-cause mortality. But 'Characteristics of included studies' explicitly says no study reported its impact on cancer-specific mortality. The copy provides no page numbers for these passages. (LLM, conf=0.91)
Experimental — accuracy not yet measured
- Premisecitation
Quit2Heal is the first known smartphone app specifically designed to help cancer patients quit smoking.
“our research team followed an agile, user-centered design framework27 to develop the first known smartphone app (called “Quit2Heal”) specifically designed to help cancer patients quit smoking.28”
Quote in the paperNot a substantial claim1 of 1 sources checked- cites [28] source
- Premisecitation
Post-diagnosis smoking is associated with an increased risk of second primary cancers.
“increased risk of second primary cancers,11”
Quote in the paperSubstantial claim1 of 1 sources checked- cites [11] source
The Abstract reports that smoking status at the first cancer diagnosis was associated with subsequent primary cancer risk. But the Limitations section says smoking was not assessed during follow-up, so the study cannot establish the association specifically for post-diagnosis smoking. (LLM, conf=0.88)
Experimental — accuracy not yet measured
- Premisecitation
In the pilot RCT, self-reported 30-day point prevalence abstinence at 2 months was 20% for Quit2Heal versus 7% for QuitGuide (OR=5.16; 95% CI 0.71-37.29; p=.10).
“Self-reported 30-day point prevalence abstinence (PPA) rates were 20% for Quit2Heal vs. 7% for QuitGuide (OR=5.16; 95% CI: 0.71-37.29; p=.10) at the 2-month follow-up.”
Quote in the paperSubstantial claim1 of 1 sources checked- cites [28] source
- Premisecitation
Quit2Heal is based on Acceptance and Commitment Therapy principles.
“Quit2Heal is also based on the principles of Acceptance and Commitment Therapy (ACT), a behavioral approach that promote smoking cessation by teaching skills to observe and accept cravings to smoke without smoking.39”
Quote in the paperSubstantial claim1 of 1 sources checked- cites [39] source
The ACT: A CBS Approach sections on intervention components and theoretical processes describe acceptance and present-moment awareness, and mention a smoking-specific measure. They do not identify Quit2Heal or establish that it uses ACT principles, so the source supports the description of ACT but not the claim about this particular program. (LLM, conf=0.84)
Experimental — accuracy not yet measured
- Study design and conductcitation
Participants with missing outcome data will be classified as smokers.
“All those with missing outcome data will be coded as smokers, as is standard in digital intervention smoking cessation trials.66,67”
Quote in the paperSubstantial claim2 of 2 sources checked - Study design and conductown data
With 422 participants (211 per arm), if 12-month 30-day PPA is 13.6% in Quit2Heal and 4.7% in QuitGuide, and missing outcomes are treated as smoking, power is at least 80% to detect a clinically meaningful between-arm difference in cessation.
“With a sample of 422 (211 in each arm), wherein missing outcome data is imputed as smoking, if we observe a 13.6% 30-day PPA at the 12-month follow-up in the Quit2Heal arm and a 4.7% 30-day PPA at the 12-month follow-up in the QuitGuide arm, we will have at least 80% power to detect a clinically meaningful difference in smoking cessation between treatment arms.”
Quote in the paperSubstantial claim2 of 4 sources checked- cites [28] source
Split into 2 atoms — 0 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 1 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measured - cites [61] source
- cites [62] source
- cites [63] source
Split into 2 atoms — 0 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 1 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measured
- Premisecitation
Prior digital smoking cessation trials used social media recruitment to enroll participants nationwide.
“we are employing social media recruitment strategies that yielded nationwide recruitment in previous digital smoking cessation trials”
Quote in the paperNot a substantial claim1 of 2 sources checked - Premisecitation
The power estimates come from the Quit2Heal pilot's 2-month self-reported quit rates, 12-month relapse, and attrition in outcome data.
“These estimates are based on the self-reported quit rates at the 2-month follow-up observed in the Quit2Heal pilot trial, relapse by 12 months, and participant outcome data attrition.28,61–63”
Quote in the paperSubstantial claim2 of 4 sources checked- cites [28] source
The Results report self-reported quit rates and outcome-data attrition at the 2-month follow-up. The Limitations discuss the likelihood of relapse after 2 months and recommend a 12-month follow-up, but this pilot did not observe or estimate relapse by 12 months. (LLM, conf=0.88)
Experimental — accuracy not yet measured - cites [61] source
- cites [62] source
- cites [63] source
The Results (page unavailable) report a 55.1% self-reported abstinence rate at two months, and the Methods describe how missing follow-up data were handled. But this paper does not identify its pilot as Quit2Heal or say that its rates informed the citing paper’s power estimates. Its own follow-up ended at three months; the 12-month relapse information in the Discussion concerns a different study. (LLM, conf=0.83)
Experimental — accuracy not yet measured
- Study design and conductreasoning
Informing all participants about the verification testing but not about their selection is meant to help them grasp the testing's importance, expect it, and avoid different reporting of smoking status by selected versus non-selected participants.
“During the informed consent, all trial participants are informed of the verification testing procedure, but not of their selection to: (1) help them understand the importance of the verification testing, (2) anticipate this testing, and (3) prevent differential reporting of smoking status between those selected and not selected for testing.”
Quote in the paperSubstantial claim - Premisecitation
85% of US adults own smartphones.
“especially since 85% of adults in the US own smartphones.25”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [25]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Premisecitation
Post-diagnosis smoking is associated with poorer cancer treatment efficacy, including lower response to radiation and chemotherapy.
“This persistence in post-diagnosis smoking occurs in spite of the serious medical outcomes, including poorer treatment efficacy (e.g., lower response to radiation and chemotherapy for cancer treatment),7–10”
Quote in the paperSubstantial claim0 of 4 sources checked - Study design and conductnone given
The trial uses an active control comparison.
“(2) active control comparison;”
Quote in the paperNot a substantial claim - Study design and conductnone given
The trial includes long-term follow-up.
“(4) long-term follow-up;”
Quote in the paperNot a substantial claim - Study design and conductnone given
The trial objectively measures smoking status in a random 10% subsample.
“(5) objectively measured smoking status among a randomly selected 10% subsample;”
Quote in the paperNot a substantial claim - Study design and conductnone given
The trial uses empirically validated assessments.
“(9) empirically validated assessments;”
Quote in the paperNot a substantial claim - Study design and conductown data
The trial uses a randomized controlled design.
“The strengths of this trial include: (1) randomized controlled study design;”
Quote in the paperSubstantial claim
- May combine two claims. 21
- Classified as probably not a substantial claim. 21
May combine two claims.
PremisecitationEvidence-based smoking cessation treatments exist for the general population but are rarely implemented in oncology care or offered to cancer patients.
“While efficacious evidence-based smoking cessation treatments exist for the general population, existing treatments are rarely implemented in oncology care or offered to cancer patients.14–16”
- Also stated in: § Abstract · plain
“However, evidence-based cessation programs are rarely implemented in oncology care, and smoking is not consistently treated in cancer treatment settings.”
Quote in the paperSubstantial claim3 of 3 sources checked- cites [14] source
The Introduction (page not supplied) says smoking cessation interventions are effective in adults and that only 39% of oncologists routinely provide treatment or a referral, supporting the efficacy and underuse portions of the claim. But the Abstract’s conclusion (page not supplied) says most NCI-designated cancer centers offer tobacco treatment services to cancer patients, so the claim that treatments are rarely offered is too broad. (LLM, conf=0.88)
Experimental — accuracy not yet measured - cites [15] source
The Introduction states that smoking cessation treatments are not frequently provided as part of cancer care and that most oncology clinicians do not routinely assist patients. It calls the treatments science-based and cites clinical guidelines, but does not establish their efficacy in the general population, so that part of the sentence is not supported by this paper’s text. (LLM, conf=0.84)
Experimental — accuracy not yet measured - cites [16] source
- Also stated in: § Abstract · plain
May combine two claims.
PremisecitationIn the pilot RCT, Quit2Heal participants showed greater improvements in shame, stigma, depression, and anxiety than QuitGuide participants, but these differences were not statistically significant (all p>.05).
“Compared to QuitGuide participants, Quit2Heal participants showed greater improvements in shame, stigma, depression, and anxiety, albeit not statistically significant (all p>.05).”
Quote in the paperNot a substantial claim1 of 1 sources checked- cites [28] source
May combine two claims.
InterpretationcitationSmartphone apps may be a low-cost alternative to in-clinic cessation programs because they require no insurance or travel and can be tailored to cancer patients.
“Remotely delivered behavioral programs for smoking cessation such as smartphone applications (“apps”) may provide a low-cost alternative to in-clinic programs since apps do not require health insurance or travel, and can be specifically tailored to cancer patients’ needs.23,24”
Quote in the paperSubstantial claim1 of 2 sources checked- cites [23] source
The Discussion (page not provided) says evidence-based smartphone apps might become useful smoking-cessation tools. It does not describe them as a low-cost alternative to in-clinic programs, address insurance or travel, or discuss tailoring apps to cancer patients. (LLM, conf=0.85)
Experimental — accuracy not yet measured - cites [24] source
May combine two claims.
PremisecitationQuitting smoking after a cancer diagnosis reduces harms and improves prognosis and survival odds.
“By contrast, quitting smoking after a cancer diagnosis dramatically reduces these harms and improves prognosis and odds of survival.6,12,13”
Quote in the paperSubstantial claim3 of 3 sources checked- cites [6] source
The Abstract reports higher overall mortality among patients smoking at diagnosis than among recent quitters, and the Epidemiology section suggests cessation may benefit cancer patients. But smoking was assessed only around diagnosis, with no follow-up smoking assessment; the paper does not establish that quitting after diagnosis dramatically reduces harms or causes better survival. (LLM, conf=0.90)
Experimental — accuracy not yet measured - cites [12] source
The Results (p. 2) associate smoking at diagnosis with worse survival in women with ovarian cancer and note better survival among former smokers. But smoking status was measured before diagnosis, not as quitting afterward; the apparent benefit of longer time since quitting was attenuated after adjustment for lifetime smoking exposure (Results, p. 2). The paper therefore does not establish that quitting after diagnosis dramatically improves prognosis or survival. (LLM, conf=0.87)
Experimental — accuracy not yet measured - cites [13] source
The Discussion reports that, among patients with early-stage lung cancer, quitting was associated with lower risks of recurrence, a second primary tumour, or death; the Abstract reports substantially higher modelled five-year survival for quitters. The claim extends this preliminary observational evidence to cancer diagnoses generally and states a causal reduction in harms more firmly than the review establishes. (LLM, conf=0.88)
Experimental — accuracy not yet measured
May combine two claims.
PremisecitationUS cancer centers offer smoking cessation services, but these programs are limited by hospital financial resources and staff training availability.
“And while cancer research centers in the US do offer smoking cessation services to cancer patients, including the National Cancer Institute (NCI) Moonshot-funded Cancer Center Cessation Initiative (C3I) at NCI-designated cancer centers, these cessation programs are limited by hospital financial resources and availability of training to clinical staff.17–20”
Quote in the paperSubstantial claim2 of 4 sources checked- cites [17] sourceExperimental — accuracy not yet measured
- cites [18] source
The Introduction (page unavailable) describes C3I cessation services and identifies inadequate clinician training and limits on insurance reimbursement as barriers to treatment. The Discussion (page unavailable) also notes limited resources and staffing, but does not specifically establish that hospital financial resources limit these programs. (LLM, conf=0.85)
Experimental — accuracy not yet measured - cites [19] source
- cites [20] source
May combine two claims.
PremisecitationCancer-related shame, stigma, depression, anxiety, and lack of knowledge about the consequences of continued smoking versus quitting are five core processes that have predicted smoking frequency, cessation, and relapse in cancer patients.
“These five core processes have predicted smoking frequency,33,34,36 cessation,33,35,36 and relapse in cancer patients.35”
Quote in the paperSubstantial claim3 of 4 sources checked- cites [33] source
The Results section (page unavailable) reports an association between lung cancer stigma and depressive symptoms and compares stigma by smoking status. The Methods section (page unavailable) defines smoking-status categories, but our copy does not report whether the five named processes predict smoking frequency, cessation, or relapse. Searched for smoking cessation, relapse, frequency, and knowledge about continued smoking versus quitting. (LLM, conf=0.76)
Experimental — accuracy not yet measured - cites [34] source
The Results and Discussion (page not specified) associate depressive symptoms with continued smoking versus cessation among survivors of smoking-related cancers. The Discussion also reports prior research linking depression to smoking intensity and relapse, but does not establish those outcomes for cancer patients. The paper does not show that shame, stigma, anxiety, or lack of knowledge predicted all three outcomes; it says further research is needed on beliefs about smoking as a predictor of cessation. (LLM, conf=0.87)
Experimental — accuracy not yet measured - cites [36] source
- cites [35] source
The Conclusions report that depression at the start of treatment predicted reduced smoking abstinence at one year, and the Introduction reports associations between depression and relapse. The paper does not establish that all five named processes predict smoking frequency, cessation, and relapse in cancer patients; its study concerns patients at a smoking cessation clinic, not a cancer-patient cohort. (LLM, conf=0.88)
Experimental — accuracy not yet measured
May combine two claims.
PremisecitationQuitGuide is a smoking cessation app that is not tailored and targets the general adult smoking population, following the USCPG.
“QuitGuide is a non-tailored smoking cessation app designed for the general population of adults who smoke that follows the USCPG.43”
Quote in the paperNot a substantial claim1 of 1 sources checked- cites [43] source
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationIn that observational study, up to 60% of cancer patients expressed interest in smartphone apps for learning about supportive care services.
“Importantly, that study also found that up to 60% of cancer patients expressed interest in smartphone apps to learn about supportive care services.26”
Quote in the paperNot a substantial claim1 of 1 sources checked- cites [26] source
The Results section reports that 60.0% of patients aged 45 or younger were interested in smartphone apps for learning about supportive care services. The figure applies to that age subgroup, not cancer patients overall, among whom interest was 39%; interest was also 63.2% among non-white patients. (LLM, conf=0.86)
Experimental — accuracy not yet measured
May combine two claims.
InterpretationcitationThe trial faces four main challenges-recruitment, app engagement, outcome data retention, and remote biochemical verification-primarily because participants are in active cancer treatment.
“There are four main challenges of this trial, all of which are primarily due to the challenges of study participants being in active cancer treatment (i.e., multiple treatments and appointments, shame about being a smoker with cancer, fatigue from cancer and treatment, fatalism about the benefits of quitting):29–32,73 (1) trial recruitment; (2) app intervention engagement, (3) outcome data reten”
Quote in the paperNot a substantial claim3 of 5 sources checked- cites [29] source
- cites [30] source
The Methods and Discussion link smoker-related stigma and embarrassment to concealing smoking status from health care providers. The Discussion also notes difficulties obtaining biochemical verification for a population-based estimate. The paper does not study participants in active cancer treatment or identify recruitment, app engagement, outcome retention, and remote verification as four challenges of a trial. (LLM, conf=0.84)
Experimental — accuracy not yet measured - cites [31] source
- cites [32] source
The sections “Do Hard-Hitting Anti-Tobacco Ad Campaigns Contribute to Stigma?” and “What Should be Done?” discuss stigma, shame, and guilt among patients with lung cancer. They do not identify four challenges in this trial or establish that active cancer treatment primarily causes its recruitment, app-engagement, outcome-retention, and remote-verification difficulties. Page numbers are unavailable in our copy. (LLM, conf=0.84)
Experimental — accuracy not yet measured - cites [73] source
The Discussion (p. 6) says people with a smoking-related disease may feel guilty about smoking and that biochemical confirmation can be infeasible or expensive. It does not address a trial involving people in active cancer treatment or establish its four challenges: recruitment, app engagement, outcome retention, and remote biochemical verification. (LLM, conf=0.82)
Experimental — accuracy not yet measured
May combine two claims.
PremisecitationA retention protocol already in use yielded 85-90% outcome data retention in the authors' earlier trials and was feasible in the Quit2Heal pilot.
“An established protocol that has yielded high outcome data retention rates (85-90%) in our previous trials,60 and proven feasible in the Quit2Heal pilot trial28 is currently being implemented.”
- Also stated in: § Strengths · plain
“(10) follow-up data collection methods that yielded high retention rates in our previous trials.”
Quote in the paperNot a substantial claim2 of 2 sources checked- Also stated in: § Strengths · plain
Classified as probably not a substantial claim.
Study design and conductcitationFor the primary and secondary aims, the trial will use logistic regression, controlling for the three stratification factors and for baseline factors significantly associated with the outcome.
“For the comparison of treatment arms for the primary and secondary aims, we will use logistic regression models. Models will adjust for the three stratification factors as well as baseline factors that are significantly related to the outcome.64,65”
Quote in the paperSubstantial claim1 of 2 sources checked- cites [64] source
The paper’s “Special Analytic Procedures for Stratified Data” section (page unavailable) says to include stratification factors as covariates in a multivariate model. “Alternatives to Stratified Randomization” also discusses adjusting for baseline characteristics that may influence outcomes. It does not specify logistic regression, three factors, or selecting baseline factors because they are significantly associated with the outcome. (LLM, conf=0.86)
Experimental — accuracy not yet measured - cites [65] source
Classified as probably not a substantial claim. May combine two claims.
Study design and conductnone givenResearch staff are blinded to random assignment, and treatment allocation remains concealed until data collection is completed.
“Research staff are blinded to random assignment, and treatment allocation remains concealed until data collection is completed.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown dataThe Quit2Heal trial was pre-registered on ClinicalTrials.gov (NCT04409236).
“The study was pre-registered on ClinicalTrials.gov (Identifier: NCT04409236; trial dates, July 2021 to May 2026).”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim. May combine two claims.
Study design and conductnone givenRandom assignments are concealed from participants throughout the trial, and both interventions are branded as Quit2Heal.
“Random assignments are concealed from participants throughout the trial and both interventions are branded as “Quit2Heal”.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim.
Study design and conductreasoningThe QuitGuide app is made available in a private, password-protected version labeled 'Quit2Heal' to keep participants blinded.
“The NCI’s QuitGuide app (version 2.30) is posted on the Google Play and Apple Store in a password-protected private format branded “Quit2Heal” (for blinding).”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenAll study activities were approved by the Institutional Review Board at Fred Hutchinson Cancer Center.
“All study activities were approved by the Institutional Review Board at the Fred Hutchinson Cancer Center (Protocol number: IR-10432/RG1007577).”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationOnly a small proportion of cancer patients receive care at designated cancer centers, limiting the nationwide impact of those centers' cessation programs.
“Furthermore, only a small proportion of cancer patients receive cancer care in designated cancer centers,21 thereby limiting their potential impact on smoking among cancer patients nationwide.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [21] source
Classified as probably not a substantial claim. May combine two claims.
Premisenone givenQuit2Heal is designed to address cancer-related shame, stigma, depression, anxiety, and knowledge about the consequences of smoking versus quitting.
“Quit2Heal is designed to address cancer-related shame, stigma, depression, anxiety, and knowledge about the consequences of smoking/quitting.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationQuitGuide's content comes from the NCI's smokefree.gov website, which the NCCN recommends as a digital smoking cessation resource.
“Its content is based on the NCI’s smokefree.gov website, a digital therapeutic for smoking cessation recommended as a resource by NCCN.47”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [47] source
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown dataThe trial uses randomly permuted block stratified randomization.
“A randomly permuted block stratified randomization is being used.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductnone givenRecruitment and eligibility screening methods are designed to achieve at least 30% male and 30% racial/ethnic minority representation.
“Recruitment and eligibility screening methods are designed to achieve a broad representation of patients that is at least 30% male and 30% from racial/ethnic minority groups.”
Quote in the paperNot a substantial claimMay combine two claims.
Study design and conductreasoningThe random selection of 10% of participants for biochemical verification is expected to lower false reporting, since testing is offered irrespective of what participants report about smoking.
“This random selection is expected to help reduce false reporting as the verification will be provided regardless of self-reported smoking status.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S4 (based).
Study design and conductnone givenThe trial's sample size is fully powered to detect smoking cessation outcomes.
“(6) fully powered sample size to detect smoking cessation outcomes;”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Study design and conductnone givenThe trial uses double blinding of random assignments.
“(3) double blinding random assignments;”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenThe trial uses nationwide recruitment.
“(8) nationwide recruitment;”
Quote in the paperNot a substantial claimMay combine two claims.
Interpretationown dataBecause Quit2Heal recently succeeded in a pilot study, digital therapeutics designed specifically for cancer patients may be more successful than standard digital smoking cessation programs and could eventually supplement more intensive tobacco treatment in cancer care.
“Given our recent success with Quit2Heal in a pilot study, digital therapeutics that are uniquely designed to address the needs of cancer patients have the potential for greater success than standard digital smoking cessation programs and may ultimately be used to complement more intensive tobacco treatment embedded in cancer care settings.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S4 (based).
InterpretationreasoningEvidence-based digital smoking cessation therapeutics tailored to cancer patients could help them quit smoking nationwide.
“Evidence-based digital therapeutics for smoking cessation that are uniquely tailored to the needs of cancer patients could help cancer patients quit smoking nationwide.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductnone givenThe trial examines possible treatment mediators and moderation by baseline factors.
“(7) examination of potential treatment mediators and moderation of baseline factors;”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S4 (based).
Study design and conductnone givenThose who say they are abstinent and use NRT or e-cigarettes but show high salivary cotinine will not be counted as smokers.
“Participants who self-report abstinence and NRT or e-cigarette use, and who have elevated salivary cotinine, will not be re-classified as smoking.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductcitationSensitivity checks for the main outcome will use multiple imputation for missing outcomes and a complete-case analysis.
“Sensitivity analyses of the main outcome will include multiple imputation of missing outcomes68–70 and complete case analysis of those providing follow-up data.”
Quote in the paperNot a substantial claim0 of 3 sources checkedProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenThe imputation model will include important baseline factors, such as heaviness of smoking, that are associated with the cessation outcome.
“The imputation model will incorporate important baseline factors (e.g., heaviness of smoking) associated with the cessation outcome.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S4 (based). May combine two claims.
Interpretationnone givenShould it succeed, Quit2Heal-a cessation intervention tailored to cancer patients-would deliver a more effective and widely scalable treatment that could be added to oncology care and improve cancer outcomes.
“If successful, Quit2Heal for smoking cessation specifically designed for cancer patients will offer a more effective, broadly scalable cessation treatment that could be implemented alongside existing oncology care, thereby improving cancer outcomes.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim. May combine two claims.
Study design and conductreasoningCotinine results will help show whether false reporting varies by arm and will permit adjustment of secondary cessation outcomes through multiple imputation for those not randomly chosen to give a sample.
“Cotinine data will help determine whether false reporting differs by arm and will allow for adjustment of secondary cessation outcomes using multiple imputation for participants who are not randomly selected to provide a sample.”
Quote in the paperSubstantial claim
The paper relies on this without support.
Self-reported 30-day point prevalence abstinence is a valid measure of smoking cessation for the trial's primary outcome.
“The primary aim of the RCT is to determine whether Quit2Heal has significantly higher self-reported 30-day point prevalence abstinence at 12 months relative to QuitGuide.”
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Medication-use eligibility conflicts with the stated exception
MinorAn inclusion criterion bars current use of other smoking cessation interventions, while the exclusion criteria explicitly permit FDA-approved cessation medication. As written, a participant using such medication both fails an inclusion criterion and qualifies for the stated exception.
“(10) not currently (i.e., within past 30 days) using other smoking cessation interventions;”
“use of FDA-approved medication for cessation is not included as an exclusion criterion.”
QuitGuide section count disagrees with its list
MinorThe text says QuitGuide's education content has four main sections, but the list reaches a fifth section.
“QuitGuide’s education content on learning how to quit smoking has four main sections:”
“(5) “Staying Smokefree” with tips for remaining smoke-free and skills for fighting cravings and staying positive.”
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4 of the 76 references couldn’t be matched to a known paper.
Cited by
Sorted by citations
Santiago‐Torres, M. (2025) · American Journal of Cancer Research · doi:10.62347/spvk4847 · Cited by 1 · see citing works
Self-citation
- Authors
- Bricker, J. B., Westmaas, J. L., Ostroff, J. S., Mull, K. E., Sullivan, B. M., & Santiago-Torres, M.
- Affiliations
- University of Washington (US)
- American Cancer Society (US)
- Fred Hutch Cancer Center (US)
- Venue
- Contemporary Clinical Trials
- Publisher
- Elsevier BV
- Published
- 2023-06
- Volume
- 129
- Pages
- 107180
- ISSN
- 1551-7144 (ISSN-L)
- PMC
- PMC10283347
- OpenAlex
- W4362719721
- Cited by
- 2
- References
- 76
- Citations by year
- 2026: 1 · 2025: 1
- FWCI
- 0.35
- Type
- journal article
- Language
- en
- Open access
- green
- doi.org
- Licence
- Locations
- Contemporary Clinical Trials (publishedVersion)
- SSRN Electronic Journal (acceptedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Cancer Institute (P30CA008748, R01 CA253975)
- National Institutes of Health
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Keywords
- smoking cessation, cancer patients, mobile application, acceptance and commitment therapy, cancer-related stigma, depression, anxiety, smoking knowledge, relapse prevention, cancer care
- MeSH terms
- Smartphone, Humans, Motivation, Neoplasms, Health Behavior, Randomized Controlled Trials as Topic, Smoking Cessation, Mobile Applications
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Claims read under definition version 3 (extract-v3) on 2026-09-28.
Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-09-28.
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