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. 2025 Mar 22;27(10):1739–1749. doi: 10.1093/ntr/ntaf071

Tobacco Assessment in Actively Accruing National Cancer Institute Clinical Trials Network Trials

Sarah N Price 1,✉, Stephanie R Land 2, Kinsey Pebley 3,4, Margaret C Fahey 5,6,2, Amanda M Palmer 7,8, Marcia H McCall 9, Pamela J Raper 10,11,2, Alana M Rojewski 12,13, Ivana T Croghan 14, Lynne I Wagner 15,16,17, Benjamin A Toll 18,19
PMCID: PMC12453689  PMID: 40123512

Abstract

Introduction

Tobacco use can adversely affect cancer treatment outcomes, yet routine assessment has not been fully incorporated into oncology clinical trials. In 2012, rates of tobacco use assessment in actively accruing National Cancer Institute (NCI) trials were < 30% at enrollment and < 5% during follow-up, prompting efforts by the NCI and major oncology associations to promote and standardize tobacco assessment in oncology research and practice (including development of the Cancer Patient Tobacco Use Questionnaire [C-TUQ]). This study was conducted to re-examine assessment patterns in 2022 (including utilization of the C-TUQ) and evaluate progress.

Aims and Methods

Protocols and forms from 144 actively accruing (as of December 2022) NCI National Clinical Trials Network (NCTN) trials were evaluated using a standardized coding instrument.

Results

Of 144 trials, 49.3% assessed tobacco use at enrollment (43.8% measured cigarettes, 14.8% e-cigarettes, and ≤ 12.5% other tobacco products). Approximately 20.8% used at least one C-TUQ question, but only 3.5% used all four core items. Few measured second-hand smoke exposure (3.5%) or quit interest (2.8%). At follow-up, 8.3% assessed any form of tobacco use. Assessment rates were higher in smoking-related cancer trials.

Conclusions

Almost half of the accruing trials did not measure any tobacco use and fewer used the C-TUQ. There was a ≥ 70% increase in tobacco use assessment at enrollment and follow-up compared to 2012, an improvement with room for further enhancement. Standardized tobacco use information enhances investigators’ ability to estimate cancer treatment efficacy, offer equitable cessation support, and accurately understand the impact of tobacco use on treatment outcomes.

Implications

In 2012, few (< 30%) cancer clinical trials evaluated tobacco use at enrollment and < 5% did so during follow-up, prompting efforts to promote and standardize tobacco assessment in oncology research and practice (including the development of the Cancer Patient Tobacco Use Questionnaire [C-TUQ]). The present study builds on this foundational paper and finds an overall increase in tobacco use assessment with room for improvement: 49.3% of trials in 2022 assessed tobacco use at enrollment and 8.3% did so during follow-up. About 20.8% used at least one C-TUQ question, highlighting that tobacco use assessment is not yet fully incorporated into oncology clinical trials.

Introduction

Continued tobacco use among patients with cancer is common; approximately one in four adults in the United States (US) with cancer smoke cigarettes at the time of their diagnosis.1 Although most attempt to quit, up to 64% continue to smoke.2–4 Tobacco use following a cancer diagnosis adversely impacts a multitude of treatment outcomes including impairing response to cancer treatment,5–8 worsening quality of life, increasing overall symptom burden,9–14 increasing risk for recurrence or second primary tumors,6,15–17 and worsening survival.6,15,18–21 Conversely, quitting smoking improves patient outcomes, including survival.22–24 Given the prevalence and impact of tobacco use, assessment and referral to tobacco treatment are critically important parts of oncologic care.25–27

Unfortunately, previous research by Peters and colleagues (2012) found suboptimal measurement of tobacco use in the context of National Cancer Institute (NCI) Cooperative Group Program (now NCI National Clinical Trials Network [NCTN]) trials. Less than one-third of trials assessed tobacco use at enrollment and only 4.5% assessed tobacco use during follow-up.28 The trials that evaluated tobacco use did not use standardized approaches.28 These findings that few clinical trials systematically assess a major treatment effect modifier prompted efforts to enhance tobacco assessment and treatment in cancer care, including policy statements by the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO). These statements recommend that all patients with cancer be asked about their tobacco use during clinical care and research and that all patients using tobacco be provided with evidence-based cessation assistance through intervention models such as the 5As (Ask about tobacco use, Advise to quit, Assess interest in quitting, Assist by providing counseling and pharmacotherapy, and Arrange follow-up).27,29,30 In the decade since Peters et al.’s foundational study, the 2013 NCI-AACR Cancer Patient Tobacco Use Assessment Task Force called for all trials to use standardized tobacco assessment and developed the Cancer Patient Tobacco Use Questionnaire (C-TUQ) in 2016.25,31 The rigorously tested C-TUQ was designed to comprehensively measure tobacco use among patients with cancer, including four core items which can be used to determine current smoking status as well as cumulative tobacco exposure: (1) have you smoked at least 100 cigarettes (5 packs = 100 cigarettes) in your entire life?; (2) how many total years have you smoked (or did you smoke) cigarettes? Do not count any time you may have stayed off cigarettes; (3) On average when you have smoked, about how many cigarettes do you (or did you) smoke a day?; and (4) How long as it been since you last smoked a cigarette (even one or two puffs)?25,32 In addition to these core items, the C-TUQ also includes items related to use of other tobacco-related products, cessation products, and assistance methods, and questions specific to the cancer treatment setting.25,32 The authors of the C-TUQ recommend tobacco use assessment at a minimum at baseline (with the four core questions) and once during follow-up (at the end of therapy with the first and fourth core questions), although more frequent or comprehensive assessment may be advisable depending on the specific research question.25

The present study aimed to update previous work by Peters et al.28 by replicating methods used in ongoing trials to understand the current state of tobacco assessment in active/open NCTN trials 10 + years since the original study. We also sought to evaluate the frequency of C-TUQ use, with a focus on the four recommended core items. Finally, we investigated study characteristics that were associated with the assessment of tobacco use at the time of trial enrollment.

Methods

Data Source and Inclusion Criteria

The data sources for this study (not considered human subjects research) included protocols and case report forms (CRFs) from actively accruing trials within the NCTN. Potentially eligible studies were identified using the protocol search tool within the NCI Clinical Trials Support Unit (CTSU) website using the following criteria: (1) the study included (but was not limited to) adults ages 18+; (2) the trial had an “active” (i.e., open to accrual) status in CTSU as of December 7, 2022 (the date of the protocol search); (3) the trial protocol and CRFs were available online from the CTSU; and (4) lead organization was in the US. The initial search identified 163 trials, 19 of which were excluded (5 = non-US; 13 = temporarily closed; and 1 = CRFs not accessible), leaving an analytic sample of 144 trials.

A data abstraction form was developed in REDCap33,34 to collect trials’ descriptive characteristics and tobacco assessment information at intake and follow-up. Some fields (eg, disease site, status) were extracted directly from the CTSU protocol search, whereas other fields (eg, cancer stage, tobacco assessment) were manually abstracted by independent coders from clinicaltrials.gov, study protocols, and CRFs. The data abstraction team consisted of five independent coders (SNP, AMP, MCF, KP, and MHM). The abstraction team initially coded 10 trials to refine and finalize the abstraction form. Initial agreement was 79% across all coders, which increased to 95% following a group discussion and revision of the abstraction form. The remainder of the trials were scored by two independent coders, and any discrepancies were resolved by the lead author (SNP) using previously agreed-upon rules. Following data checks for completeness and accuracy, the data were exported from REDCap into R version 4.4.0 for analysis.35

Data Analysis

Descriptive statistics were used to summarize trial characteristics and assessment of tobacco status. The trial phase was re-coded as “early phase (I, I/II),” “mid-phase (II, II/III),” and “late phase (III) or other.” Cancer type was re-coded as “tobacco-related” (cancers of oropharynx, larynx, esophagus, lung, stomach, liver, pancreas, kidney, ureter, bladder, cervix, colorectum, and acute myeloid leukemia) or “not tobacco-related” based on the 2014 Surgeon General’s Report.21 Informed by extant research demonstrating lower rates of tobacco use assessment for patients with more advanced cancer,36 cancer stage was re-coded into “early-stage only,” “inclusive of advanced/metastatic,” or “N/A.” The accrual start date was re-coded as “2016 and before” and “2017 and after” based on the publication of the C-TUQ in 2016. Bivariable and multivariable logistic regression models were used to examine associations between tobacco assessment at enrollment and trial characteristics (eg, phase of trial, cancer type, cancer stage, target accrual, and accrual start date).

Results

Trial Characteristics

The 144 protocols included in this analysis were conducted by the five NCTN groups: Alliance for Clinical Trials in Oncology (ALLIANCE) which includes legacy groups American College of Surgeons Oncology Group, Cancer and Leukemia Group B, and North Central Cancer Treatment Group; the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) which includes legacy groups Eastern Cooperative Oncology Group and American College of Radiology Imaging Network; NRG Oncology (NRG) which includes legacy groups National Surgical Adjuvant Breast and Bowel Project, Radiation Therapy Oncology Group, and Gynecologic Oncology Group (NRG); Southwest Oncology Group (SWOG); and the Children’s Oncology Group (COG). Table 1 describes trial characteristics. Accrual start dates (enrollment of first participant following activation) ranged from September 2009 to May 2023; 13 (9.0%) started accruing during or before 2016 (the year the C-TUQ was published), the remaining 131 (91.0%) started accruing 2017 or later. Accrual targets ranged from 20 to 8300; actual accruals ranged from 1 to 1704. Of the 144 included protocols, five (2.5%) were early therapeutic trials focused on dosage, safety, and initial efficacy (phase I or I/II), 83 (57.6%) were phase II or II/III trials focused on safety and efficacy in a medium size sample, and 53 (36.8%) were phase III trials focused on efficacy and adverse events in a larger sample size. The remaining three (2.1%) involved screening, triage, and adverse event tracking across multiple therapeutic trials. On average, studies had accrued 35.5% of their target accrual at the time of the CTSU protocol search. Trials of patients with genitourinary and lung cancers represented the largest percentage of trials (19.4%) and the largest percentage of patients (17,706, 24.6%), respectively. Approximately half of the trials (76 trials, 52.8%) studied tobacco-related cancers, 62 (43.0%) studied cancers that were not tobacco-related, and the remaining six (4.2%) studied a mix of sites that could not be classified by tobacco-relatedness. Ten (6.9%) trials were open to only patients with early, localized, or resectable cancers; 89 (61.8%) were open to patients with a range of disease severity inclusive of advanced or metastatic cancers (eg, II-IV, IA-IIIC); and the remaining 44 (30.6%) did not have applicable staging-related inclusion criteria.

Table 1.

Trial Characteristics (N = 144 Trials, 71,950 Planned Accruals)

Characteristic Number (%) of trials Number (%) of planned accruals
Cooperative group
 Alliance 34 (23.6%) 19,148 (26.6%)
 ECOG-ACRIN 43 (29.9%) 17,478 (24.3%)
 NRG 32 (22.2%) 19,056 (26.5%)
 SWOG 27 (18.8%) 11,167 (15.5%)
 COG 8 (5.5%) 5,101 (7.1%)
Primary phase of trial
 Early (Phase I or I/II) 5 (3.5%) 652 (0.9%)
 Mid (Phase II or II/III) 83 (57.6%) 24,424 (33.9%)
 Late (Phase III) 53 (36.8%) 35,387 (49.2%)
 Other/Not applicable 3 (2.1%) 11,487 (16.0%)
Disease site
 Bone/sarcoma 3 (2.1%) 458 (0.6%)
 Breast 6 (4.2%) 5,335 (7.4%)
 CNS 9 (6.2%) 1,397 (1.9%)
 Cutaneous 8 (5.6%) 1,445 (2.0%)
 Gastrointestinal 21 (14.6%) 7,783 (10.8%)
 Genitourinary 28 (19.4%) 16,412 (22.8%)
 Gynecologic 4 (2.8%) 1,235 (1.7%)
 Head and neck 11 (7.6%) 4,925 (6.9%)
 Hematologic 18 (12.5%) 7,951 (11.1%)
 Lung 21 (14.6%) 17,706 (24.6%)
 Neuroendocrine 6 (4.2%) 1,120 (1.6%)
 Other/More than one type 9 (6.2%) 6,183 (8.6%)
Disease stage
 Early only (I-II) 10 (6.9%) 8,167 (11.3%)
 Inclusive of advanced/metastatic 89 (61.8%) 44,380 (61.7%)
 N/A or none specified 44 (30.6%) 19,403 (27.0%)
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Note: ECOG-ACRIN = Eastern Cooperative Oncology Group-American College of Radiology Imaging Network; NRG = National Surgical Adjuvant Breast and Bowel Project, Radiation Therapy Oncology Group, and Gynecologic Oncology Group; SWOG = Southwest Oncology Group; COG = Children’s Oncology Group; CNS = central nervous system.

Discussion of Tobacco in Protocol Texts

A keyword search of protocols for “tobacco,” “smok,” “cig,” “vap,” or “nicotine” found that 29 of 144 trials (20.1%) mentioned any tobacco product use directly in their protocol. Of the 29 protocols that mentioned tobacco, seven (24.1%) mentioned tobacco as a risk factor for cancer; nine (31.0%) mentioned that tobacco use could influence treatment outcomes; eight (27.6%) mentioned tobacco use as both a risk factor and potential influence on outcomes; one (3.4%) excluded patients who were smoking/vaping; and four (13.8%) mentioned smoking or tobacco use as part of data collection. In addition, 15 (51.7%) mentioned including tobacco use in their analyses; 10/15 (66.7%) examined tobacco use as a covariate or stratification factor; 4/15 (26.7%) described a tobacco-focused ancillary study; and 1/15 (6.7%) mentioned tobacco use as both inclusion/exclusion factor and as part of analyses. Only four (2.8% of all 144 protocols) mentioned the Cancer Patient Tobacco Use Questionnaire (C-TUQ) specifically; these studies were part of an ancillary study focused on the incorporation of the C-TUQ in nine ECOG-ACRIN trials (EAQ16T).37–39 Only 5/144 protocols (3.5%) mentioned a tobacco cessation service or treatment for patients who use tobacco, 4/5 (80%) of which were part of EAQ16T.

Tobacco Assessment at Study Enrollment

Table 2 provides detailed information regarding tobacco use assessment in trial protocols. Of the 144 trials, 71 (49.3%) assessed at least one aspect of tobacco product use (ie, any former or current cigarette, e-cigarette/electronic nicotine delivery system [ENDS], pipe, cigar, smokeless, or unspecified “smoking” or “tobacco” use) at enrollment. Of these trials, assessing tobacco product use, 64/71 (90.1%) specifically assessed cigarettes, 21/71 (29.6%) assessed e-cigarettes/ENDS, 7/71 (9.9%) assessed pipes, 18/71 (25.4%) assessed cigars, 9/71 (12.7%) assessed smokeless tobacco, 7/71 (9.9%) assessed unspecified “smoking,” and 7/71 (9.9%) quantified smoke exposure using pack years.

Table 2.

Tobacco Assessment Rates at Baseline/Enrollment and During Follow-Up

Characteristic No. of trials assessing at baseline/enrollment % of included trials (N = 144) % of trials assessing tobacco use at enrollment (N = 71) No. of trials assessing at follow-up % of included trials (N = 144) % of trials assessing tobacco use at follow-up (N = 12)
Any tobacco assessment 71 49.3% 100% 12 8.3% 100%
 Cigarettes 64 44.4% 90.1% 11 7.6% 91.7%
 E-cigarette/ENDS 21 14.6% 29.6% 6 4.2% 50.0%
 Pipe 7 4.9% 9.9% 5 3.5% 41.7%
 Cigar 18 12.5% 25.4% 4 2.8% 33.3%
 Smokeless 9 6.3% 12.7% 5 3.5% 41.7%
 Unspecified smoking 7 4.9% 9.9% 1 0.7% 8.3%
Cigarettes
 Current use 63 43.4% 88.7% 6 4.2% 50.0%
 Former use 63 43.4% 88.7% 4 2.8% 33.3%
 Age/date/years ago started 28 19.4% 39.4% – – –
 Age/date/years ago stopped 29 20.1% 40.8% – – –
 Years used 30 20.8% 42.3% – – –
 Amount per day used 34 23.6% 47.9% – – –
 Last use (for current or former) 7 4.9% 9.9% 1 0.7% 8.3%
 Pack years 7 4.9% 9.9% – – –
E-cigarette/ENDS
 Current use 21 14.6% 29.6% – – –
 Former use 20 13.9% 28.2% – – –
 Age/date/years ago started 1 0.7% 1.4% – – –
 Age/date/years ago stopped 13 9.0% 18.3% – – –
 Years used 3 2.1% 4.2% – – –
 Amount per day used 3 2.1% 4.2% – – –
 Last use (for current or former) 1 0.7% 1.4% – – –
Pipe
 Current use 6 4.2% 8.5% – – –
 Former use 6 4.2% 8.5% – – –
 Age/date/years ago started 1 0.7% 1.4% – –
 Age/date/years ago stopped 2 1.4% 2.8% – – –
 Years used 3 2.1% 4.2% – – –
 Amount per day used 3 2.1% 4.2% – – –
 Last use (for current or former) 1 0.7% 1.4% – – –
Cigar
 Current use 18 12.5% 25.4% – – –
 Former use 18 12.5% 25.4% – – –
 Age/date/years ago started 1 0.7% 1.4% – – –
 Age/date/years ago stopped 13 9.0% 18.3% – – –
 Years used 3 2.1% 4.2% – – –
 Amount per day used 3 2.1% 4.2% – – –
 Last use (for current or former) 1 0.7% 1.4% – – –
Smokeless
 Current use 8 5.6% 11.3% – – –
 Former use 8 5.6% 11.3% – – –
 Age/date/years ago started 1 0.7% 1.4% – – –
 Age/date/years ago stopped 2 1.4% 2.8% – – –
 Years used 3 2.1% 4.2% – – –
 Amount per day used 3 2.1% 4.2% – – –
 Last use (for current or former) 1 0.7% 1.4% – – –
Unspecified smoking
 Current use 6 4.2%) 8.5% – – –
 Former use 7 4.9% 9.9% – – –
 Age/date/years ago started 0 0% 0% – – –
 Age/date/years ago stopped 0 0% 0% – – –
 Years used 1 0.7% 1.4% – – –
 Amount per day used 0 0% 0% – – –
 Last use (for current or former) 0 0% 0% – – –
Smoking cessation*
 Current quit (or reduction attempt) 4 2.8% 5.6% 4 2.8% 33.3%
 Interest in quitting (or reduction) 4 2.8% 5.6% 5 3.5% 41.7%
 Longest quit attempt 0 0% 0% 1 0.7% 8.3%
 Quit method used 4 2.8% 5.6% 4 2.8% 33.3%
 Services offered 4 2.8% 5.6% 4 2.8% 33.3%
Second-hand smoke exposure 5 3.5% 7.0% 4 2.8% 33.3%
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Note: ENDS = Electronic Nicotine Delivery System.

*The four trials collecting cessation information were all part of EAQ16T (C-TUQ ancillary study).

Of the trials assessing cigarette smoking at enrollment, 63/64 (98.4%) assessed current vs. former vs. never use; 28/64 (43.8%) assessed when participants started smoking cigarettes; 29/64 (45.3%) assessed when (if former) they stopped smoking cigarettes; 34/64 (53.1%) assessed years smoked; 34/64 (53.1%) assessed cigarettes smoked per day; and 7/64 (10.9%) assessed the last time participants smoked cigarettes (asked of current and former cigarette smokers).

Of the trials that collected cigarette smoking status at enrollment, 56/63 (88.9%) defined ever smoking as 100 cigarettes or five packs in one’s lifetime, 2/63 (3.2%) as 20 packs in one’s lifetime, and the remaining 5/63 (7.9%) did not specify. Nine of 63 (14.3%) defined former smoking as > 1 year since last cigarette, 4/63 (6.3%) as 30 days/1 month since last cigarette, 1/63 (1.6%) as 6 months since last cigarette, and 26/63 (41.3%) split former use into former and recent quit (eg, < 1 year ago/> 1 year ago). The remaining 23/63 (36.5%) did not define former smoking.

Only five trials (3.5% of the total sample of 144, 7.0% of the 71 studies assessing tobacco use at enrollment) collected information about second-hand smoke exposure or asked patients about interest in quitting. The EAQ16T trials also included additional questions on the 5As (clinician-delivered brief tobacco assessment and intervention)30 and perspectives on the relationship between smoking and cancer-related symptom burden. Additional tobacco-related questions in other studies included the timing of smoking after waking, type and duration of second-hand smoke, and cannabis use (one study each out of 71, 1.4% of the sample assessing tobacco use). With respect to specific items on the C-TUQ, 30 (42.3% of 71 trials assessing tobacco at enrollment and 20.8% of the total sample of 144) included at least one verbatim question from the C-TUQ or one question with similar wording (see Table 3 for the questions). Of the recommended four core items of the C-TUQ to be asked at enrollment, 30 (42.3% of 71 trials assessing tobacco, 20.8% of the total sample of 144) asked “Have you smoked at least 100 cigarettes (5 packs=100 cigarettes) in your entire life?”; 21 (29.6% of trials assessing tobacco, 14.6% of total sample) asked “How many total years have you smoked (or did you smoke) cigarettes? Do not count any time you may have stayed off cigarettes)”; 23 (32.4% of trials assessing tobacco, 16.0% of total sample) asked “On average when you have smoked, about how many cigarettes do you (or did you) smoke a day?”; and five (7.0% of trials assessing tobacco, 3.5% of total sample) asked “How long has it been since you last smoked a cigarette (even one or two puffs)?.”

Table 3.

Frequency of Asking C-TUQ Questions* at Baseline

C-TUQ question Number of trials % of total sample (N = 144) % of trials assessing tobacco (N = 71)
1. Have you smoked at least 100 cigarettes (5 packs = 100 cigarettes) in your entire life? 30 20.8% 42.3%
2. How old were you when you first smoked a cigarette (even one or two puffs)? 0 0% 0%
3. How old were you when you first began smoking cigarettes regularly? 17 11.8% 23.9%
4. How many total years have you smoked (or did you smoke) cigarettes? Do not count any time you may have stayed off cigarettes 21 14.6% 29.6%
5. On average when you have smoked, about how many cigarettes do you (or did you) smoke a day? 23 16.0% 32.4%
6. How long has it been since you last smoked a cigarette (even one or two puffs)? 5 3.5% 7.0%
7. During each of the following time frames, please indicate whether you smoked cigarettes every day, some days, or not at all…
 The year before you were first told you had cancer 4 2.8%** 5.6%
 After diagnosis, and before treatment started 4 2.8% 5.6%
 From 2 days before your last cancer surgery to 2 days after 4 2.8% 5.6%
 During the course of treatment 4 2.8% 5.6%
 After treatment ended 4 2.8% 5.6%
 Since your last visit to this clinic 4 2.8% 5.6%
8. Since you were first told you had cancer, which of the following products have you used regularly? 4 2.8% 5.6%
9. Since you were first told you had cancer, what was the longest time you stayed (or have stayed) off cigarettes? 0 0% 0%
10a. In the past 30 days, have you smoked cigarettes, even one or two puffs? 4 2.8% 5.6%
10b. In the past 30 days, on how many days did you smoke cigarettes? 4 2.8% 5.6%
11. Since you were first told you had cancer, which of the following products have you used to quit (or to stay off) smoking cigarettes? 4 2.8% 5.6%
12. Since you were first told you had cancer, what assistance have you used to quit (or to stay off) smoking cigarettes? 4 2.8% 5.6%
13. Have your cancer doctors advised you to quit smoking cigarettes? 4 2.8% 5.6%
14. In the past 30 days, have you been trying to quit (or trying to stay off) smoking cigarettes? 4 2.8% 5.6%
15. In the past 30 days, what, if any, products have you used to quit (or stay off) smoking cigarettes? 4 2.8% 5.6%
16. In the past 30 days, what assistance have you used to quit (or to stay off) smoking cigarettes? 4 2.8% 5.6%
17. Which of the following products have you ever used regularly? 0 0% 0%
18. In the past 30 days, which of the following products have you used? 4 2.8% 5.6%
19. Are you currently living with a smoker? 4 2.8% 5.6%
20. In the past 30 days, have you…
 Lived in a place where other people smoked cigarettes indoors? 4 2.8% 5.6%
 Worked in a place where other people smoked cigarettes indoors? 4 2.8% 5.6%
21. Thinking of all your childhood and adult years, have you ever lived in a place where other people smoked cigarettes indoors? 0 0% 0%
22. Thinking of all the years you have worked, have you ever worked in a place where other people smoked cigarettes indoors? 0 0% 0%
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The four bolded items represent the four core items of the C-TUQ.

*Includes trials using the C-TUQ question verbatim as well as trials using questions with very similar wording.

**The only trials asking C-TUQ questions 7, 8, 10a-16, and 18-20 were the EAQ16T studies.

Tobacco Assessment at Follow-Up Visits

Rates of tobacco assessment through follow-up are shown in the bottom half of Table 2. During follow-up, 12 (16.9% of 71 trials assessing tobacco at enrollment, 8.3% of the total 144) queried for any type of tobacco use. Of the trials that assessed current tobacco use during follow-up, 11/12 (91.7%) specifically assessed cigarettes, 6/12 (50.0%) assessed e-cigarettes/ENDS, 5/12 (41.7%) assessed pipes, 4/12 (33.3%) assessed cigars, 5/12 (41.7%) assessed smokeless tobacco, and 1/12 (8.3%) asked about unspecified smoking. Regarding cigarettes, 6/12 (50.0%) assessed the amount smoked per day, 4/12 (33.3%) assessed last use, 5/12 (41.7%) assessed interest in quitting, 4/12 (33.3%) assessed cessation methods, 1/12 (8.3%) assessed abstinence achievement and time since quitting, 1/12 (8.3%) assessed ever smoking, 1/12 (8.3%) assessed current use of multiple types of tobacco products, and 4/12 (33.3%) assessed current smoking frequency, receipt of the 5As, smoking and cancer-related symptom perceptions, and timing of smoking relative to cancer diagnosis and treatment (from C-TUQ).

Contribution of Trial Characteristics to Tobacco Assessment

Table 4 shows the odds of trial characteristics in a multivariable logistic regression model predicting tobacco use assessment at enrollment by trial phase, cancer type, cancer stage, planned accrual, and accrual start date. In both bivariable and multivariable models, the only significant correlate of tobacco assessment at enrollment was cancer type. Specifically, rates of assessment were higher for tobacco-related cancer trials vs not tobacco-related cancer trials (60.5% vs 37.1%; OR = 2.79 [95% CI = 1.28, 6.28]; p = .01), both independently (Supplementary Table S1) and adjusting for other trial characteristics (Table 4).

Table 4.

Association of Trial Characteristics with Tobacco Assessment at Enrollment in a Multivariable Logistic Regression Model Adjusting for Trial Phase, Disease Site, Cancer Stage, Planned Accrual, and Accrual Start (N = 144)

Trial characteristic Proportion (%) of trials that assessed tobacco use Estimate (SE) OR (95% CI) Wald statistic p-value
Disease site
 Not tobacco related 23/62 (37.10%) Ref
 Tobacco related 46/76 (60.53%) 1.03 (.40) 2.79 (1.28, 6.28) 2.54 .01*
 N/A 2/6 (33.3%) −0.15 (.94) 0.86 (0.10, 5.06) −0.16 .87
Trial phase
 Early (I-I/II) 3/5 (60.00%) Ref
 Mid (II-II/III) 39/83 (46.99%) −1.39 (0.99) 0.26 (0.03, 1.76) −1.39 .16
 Late (III) or N/A 29/56 (51.79%) −1.27 (1.02) 0.36 (0.03, 2.06) −1.24 .21
Stage
 Includes advanced/metastatic 46/89 (51.69%) Ref
 Early-stage only 8/11 (72.72%) 0.77 (0.74) 2.16 (0.55, 10.78) 1.05 .30
 N/A 17/44 (38.64%) −0.26 (0.43) 0.77 (0.31, 2.05) −0.60 .55
Planned accrual – 0.0005 (0.0004) 1.00 (1.00, 1.00) 1.30 .19
Accrual start date
 2017 and after 63/131 (48.09%) Ref
 2016 and before 8/13 (61.54%) 0.53 (0.65) 1.69 (0.48, 6.43) 0.81 .42
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Note: * p < .05.

Discussion

Tobacco use is a well-documented modifier of the effects of cancer treatment, and assessing tobacco use in clinical research and cancer care is strongly advocated by major oncology organizations. Despite this, slightly less than half (49.3%) of actively accruing NCTN therapeutic trials assessed tobacco use at enrollment, and even fewer (8.3%) assessed tobacco use at any follow-up visits. There was a commendable ≥ 70% increase in the percentage of trials assessing tobacco use in 2022 compared to Peters and colleagues’ study 10 + years earlier (49.3% vs 29.0% at enrollment, 8.3% vs 4.5% during follow-up).28 Our findings also represent an improvement over tobacco assessment rates reported in a 2013 project pooling secondary data from lung cancer clinical trials (31.3% at enrollment, 3.1% during follow-up)40 and a scoping review of NCTN trial reports published between January 2017 and October 2019 (21.1% at baseline, 2.2% during follow-up).41 Given policy statements from major oncology groups (eg, AACR, ASCO) on the importance of tobacco assessment in clinical trials, as well as the development of the C-TUQ, there is a rationale and opportunity for further improvement.27,29 In addition, protocol documents and CRFs did not mention tobacco cessation (< 5%), despite high-profile initiatives by the NCI to increase tobacco treatment at cancer centers42,43 and resources for implementing tobacco assessment and treatment developed and disseminated through these initiatives.44

When tobacco use was measured, assessment methods were largely unstandardized. Less than half of the studies that assessed tobacco use incorporated C-TUQ or similar questions. Only five studies included all four of the recommended “core” C-TUQ items, with four studies being part of the same ancillary sub-study (EAQ16T). The developers of the C-TUQ recommend use of the core questions at trial enrollment to measure tobacco use accurately and consistently, which may benefit future evaluations of cross-trial outcomes by enhancing the quality, comparability, and generalizability of findings, including enhanced statistical power for main effect and subgroup analyses.45

The majority of trials assessing smoking status (88.9%) used the recommended definition of “never cigarette use” as < 100 cigarettes in one’s lifetime.46,47 However, trials were less consistent in their definitions of current smoking. Of trials assessing smoking status, 35.9% provided no clear definition of current smoking. The remaining trials defined current smoking as within 1 year, within 6 months, or within 1 month/30 days since the last cigarette. Differing definitions of current and former smoking may impede our ability to understand the impact of smoking (and quitting smoking) on trial outcomes.40  The authors of the C-TUQ recommend defining current smoking as either < 30 days/1 month since the last cigarette or < 1 year.45

Rates of non-cigarette tobacco-related product assessment ranged from 4.9% (pipe) to 14.6% (e-cigarettes/ENDS), and only 3.5% of trials measured second-hand smoke exposure. Despite falling rates of cigarette smoking among adults, the use of other tobacco-related products, especially e-cigarettes/ENDS has been on the rise.48 While the use of these products is generally lower among cancer survivors compared to the general population,37,49 their increasing popularity suggests assessment and treatment approaches inclusive of all tobacco-related products are warranted. Furthermore, despite the prevalence and negative health impact of second-hand smoke exposure among non-smoking cancer survivors,50 fewer than 5% of trials assessed second-hand smoke exposure. We encourage trialists to consider the assessment of multiple tobacco products and second-hand smoke exposure; the C-TUQ offers the ability to efficiently assess for use of a variety of tobacco products across different time frames (eg, lifetime, since diagnosis, past 30 days) and current or lifetime second-hand exposure, which can be selected depending on the population and research question.45

We found differences in tobacco use assessment by cancer type. Compared with previous findings, a similar proportion of trials for smoking-related cancers were collecting tobacco use information (57.4% in 2012 vs 60.4% in 2022), and there was an increase in assessment rates in trials for cancers that are not smoking-related (25% in 2012 vs 37.1% in 2022). Interestingly, the aforementioned ECOG-ACRIN ancillary sub-study, EAQ16T, involved trials mostly for cancers that are not tobacco-related and found a surprisingly high rate of smoking among participants at enrollment (12% smoked cigarettes within the last 30 days, 5.5% used multiple tobacco products, and an additional 34.7% reported former cigarette smoking).37  Given that tobacco use is a demonstrated risk factor for poor outcomes for nearly every cancer type,21  efforts should be made to assess and treat all patients who use tobacco,51  regardless of whether their cancer is tobacco-related.

Few trials re-assessed tobacco use or referenced tobacco cessation support. Tobacco use assessment at multiple time points is critical, given that quitting smoking is a dynamic process. With frequent follow-up and rigorous outcome assessment methods, clinical trials offer a unique opportunity to understand the impact of cessation or reduction in tobacco use compared to continued smoking, which may significantly impact treatment outcomes of novel therapeutics. In addition, this would meet the goals of NCI to use patient-reported outcome (PRO) measures as tools within clinical trials, including early-stage trials, to better address key patient concerns and promote equitable improvement of patient outcomes.38 It is important to recognize selection of measures can involve a complicated balance of minimizing participant burden and maximizing relevant information for outcomes and moderators of effects. It is possible that some of the trialists included in this analysis considered tobacco assessment but opted to exclude these questions in favor of other important factors (eg, financial strain, cancer-related symptom burden). Given their brevity and readability, and the noted benefits of systematically assessing tobacco use in clinical trials, we believe incorporating the four core items from the C-TUQ (all four at baseline, two of the core items at follow-up) should be strongly considered.45 Future work by this author group or others may include engaging trial principal investigators, patients, study staff, and other relevant stakeholders to understand potential barriers to using the C-TUQ in the context of clinical trials.

This study has limitations. Specifically, because of the limited information available in protocols and CRFs, it is unclear how many studies relied on retrospective electronic health record reviews vs asking the patient directly about tobacco use. In addition, we may have undercounted tobacco assessment if studies had additional CRFs that were not available on the CTSU website. We chose a cross-sectional period to select actively accruing trials, which may not accurately capture variability in open trials over time in the decade since Peters and colleagues conducted their initial study. We also counted questions with wording similar but not identical to the C-TUQ as having asked that question, but we do not know if these questions were derived directly from the C-TUQ. Thus, the use of verbatim C-TUQ items is likely lower than what is reported here. We also limited our search to US-led trials given potential differences in tobacco control approaches and attitudes between countries; assessment rates may not generalize to trials in other countries. Finally, clinical trials might not be representative of typical clinical practice patterns and protocols do not describe every aspect of care that patients receive; thus, patients enrolled in these trials may be receiving tobacco assessment or cessation support through other means. Clinical trial populations are also frequently unrepresentative of the general population of patients with cancer; collection of other sociodemographic factors (eg, social determinants of health) is important to better understand sample representativeness and generalizability of effects.

Conclusion

Smoking has been established as a treatment effect modifier and a prognostic factor and should be assessed and treated in clinical trials across a broad spectrum of disease sites, as recommended by national guidelines. Despite the importance of tobacco use assessment in cancer care, slightly fewer than half of NCTN trials open to accrual as of December 2022 assessed tobacco use at enrollment, and fewer assessed tobacco use during follow-up. The C-TUQ, a questionnaire specifically designed for assessing tobacco use in oncology populations, was rarely used. Incorporating this standardized, comprehensive assessment of tobacco use into clinical trials would enhance understanding of tobacco use as a treatment effect modifier, provide accurate tobacco use data, and potentially increase referrals to cessation resources. For future NCI-funded trials, tobacco use assessment at baseline and end of treatment should be strongly considered, ideally using the C-TUQ.

Supplementary Material

Supplementary material is available at Nicotine and Tobacco Research online.

ntaf071_suppl_Supplementary_Tables_1
ntaf071_suppl_supplementary_tables_1.docx (15.6KB, docx)

Contributor Information

Sarah N Price, Department of Social Sciences and Health Policy, Wake Forest University School of Medicine, Winston-Salem, NC, USA.

Stephanie R Land, Tobacco Control Research Branch, National Cancer Institute, Bethesda, MD, USA.

Kinsey Pebley, Medical University of South Carolina Hollings Cancer Center, Charleston, SC, USA; Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.

Margaret C Fahey, Medical University of South Carolina Hollings Cancer Center, Charleston, SC, USA; Department of Psychology, Middle Tennessee State University, Murfreesboro, TN, USA.

Amanda M Palmer, Medical University of South Carolina Hollings Cancer Center, Charleston, SC, USA; Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.

Marcia H McCall, Department of Psychiatry and Behavioral Medicine, Wake Forest University School of Medicine, Winston-Salem, NC, USA.

Pamela J Raper, Department of Social Sciences and Health Policy, Wake Forest University School of Medicine, Winston-Salem, NC, USA; University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.

Alana M Rojewski, Medical University of South Carolina Hollings Cancer Center, Charleston, SC, USA; Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.

Ivana T Croghan, Department of Internal Medicine, Division of General Internal Medicine and Nicotine Research Program, Mayo Clinic, Rochester, MN, USA.

Lynne I Wagner, Department of Social Sciences and Health Policy, Wake Forest University School of Medicine, Winston-Salem, NC, USA; University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA; Department of Health Policy and Management, University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC, USA.

Benjamin A Toll, Medical University of South Carolina Hollings Cancer Center, Charleston, SC, USA; Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.

Funding

This work was supported by the National Cancer Institute (T32CA122061). We acknowledge REDCap support from the Wake Forest Clinical and Translational Science Institute (UL1TR001420). The content is solely the responsibility of the authors and does not represent the official views of the National Cancer Institute or the National Institutes of Health.

Declaration of Interests

Dr. Toll has in the past and currently testifies on behalf of plaintiffs who have filed litigation against cigarette manufacturers and JUUL Labs, Inc. The other authors declare no conflicts of interest.

Author Contributions

Sarah Price (Conceptualization [equal], Data curation, Formal analysis, Investigation [lead], Methodology [equal], Writing—original draft, Writing—review & editing [lead]), Margaret Fahey (Conceptualization, Investigation, Methodology, Validation, Writing—review & editing [equal]), Marcia McCall (Conceptualization, Investigation, Methodology, Validation, Writing—review & editing [equal]), Pamela J. Raper (Project administration [equal], Writing—review & editing [supporting]), Stephanie Land (Conceptualization, Methodology [equal], Supervision [lead], Writing—review & editing [equal]), Kinsey Pebley (Conceptualization, Investigation, Methodology, Validation, Writing—review & editing [equal]), Amanda Palmer (Conceptualization, Investigation, Methodology, Validation, Writing—review & editing [equal]), Alana Rojewski (Conceptualization, Methodology, Supervision, Writing—review & editing [equal]), Ivana Croghan (Conceptualization, Methodology, Supervision, Writing—review & editing [equal]), Lynne Wagner (Conceptualization, Methodology, Supervision, Writing—review & editing [equal]), and Benjamin Toll (Conceptualization, Methodology [equal], Supervision [lead], Writing—review & editing [equal])

Data Availability Statement

The datasets generated during and/or analyzed during the current study are available from the corresponding author upon reasonable request.

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

ntaf071_suppl_Supplementary_Tables_1
ntaf071_suppl_supplementary_tables_1.docx (15.6KB, docx)

Data Availability Statement

The datasets generated during and/or analyzed during the current study are available from the corresponding author upon reasonable request.

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