Abstract
Background:
In addition to increased morbidity and mortality, continued smoking after a cancer diagnosis results in the added risks of cancer recurrence, adverse side effects, and decreased effectiveness of first line treatments. Combining counseling and FDA (Food and Drug Administration) approved pharmacotherapy is best practice in the treatment of Tobacco Use Disorder (TUD). The SARS-CoV-19 pandemic ushered in a dramatic shift toward provision of care through telehealth platforms.
Methods:
In response to the pandemic, the MD Anderson Cancer Center’s Tobacco Research and Treatment Program (TRTP) shifted 100% of its service to a fully remote telehealth platform. Because requirements for a face-to-face visit were lifted by the Texas state government during the “public health emergency”, we were able to provide the initial consultation by phone or video. Patients selected which form of consultation they were most comfortable with.
Results:
Abstinence rates were similar at 3, 6, and 9 months regardless of the modality (phone vs video) and there were no differences in patient engagement. Patients in the phone group were more likely to be White and older.
Discussion:
The SARS-CoV-19 pandemic provided an opportunity to eliminate almost all barriers to service and to evaluate the efficacy of fully remote treatment for TUD. This period allowed unprecedented access and choice for patients. Establishing care at consultation via phone vs video did not affect patients’ ability to achieve abstinence. These results establish the efficacy of phone-delivered tobacco treatment, including the provision of medication, and can inform policy regarding requirements for such care post-pandemic.
Keywords: Tobacco Treatment, Abstinence, Telehealth, Access
1. Introduction
Smoking continues to be the primary cause of preventable death and disease in the United States. It plays a significant role in the development of chronic obstructive pulmonary disease, cardiovascular disease and at least 18 cancers[1] [2, 3]. Continued smoking after a cancer diagnosis is associated with increased cancer recurrence, increased mortality, increased adverse side effects from treatments, and a decrease in the effectiveness of first-line cancer treatments [2, 4]. The growing awareness of the impact that quitting can have on a patient’s survival and long term quality of life has led to an initiative to include evidence-based tobacco treatment in cancer centers across the country [5–7]
Best practice in tobacco treatment combines multiple intensive counseling (> 20 minutes) sessions with the provision and management of FDA-approved pharmacotherapy [8]. Cancer patients face unique stressors and often require more intensive care than what is available through Quitlines [9, 10] Traditionally, patients have been required to meet in person or over video with medical providers to receive prescription medication treatment for their smoking. The SARS-CoV-19 pandemic necessitated a shift away from this long-standing requirement, allowing these services to be offered by video or phone. [11]. [12] Tobacco treatment programs participating in the Cancer Center Cessation Initiative (C3I), supported by the U.S. National Cancer Institute Cancer Moonshot, reported increased utilization of services in response to the expansion of telehealth services [10, 13, 14, 14]. Although most programs in the C3I experienced increased utilization, some patients continued to face barriers related to technology. For example, some programs who primarily offered group treatment still required patients to access services via a video platform. Disparities exist in both access to and comfort with video technologies among older adults, minority communities, rural communities, and individuals with public insurance [12, 15, 16].
To our knowledge, there are only two studies that examined the effectiveness of tobacco treatment delivered by phone versus video with cancer patients. The first study used a pragmatic implementation design, giving cancer patients who smoke a choice between traditional Quitlines (N=39), in-person group treatment (N=14), or individual smartphone video telehealth (N=37) with remote CO testing [17]. The median age was 58 and one-third were rural tobacco users. Importantly, the 1:1 telehealth patients rated the intervention most favorably, mainly due to the treatment’s convenience and high flexibility. Limitations include the fact that the study was not powered to detect differences in quit rates and there were low rates of follow-up, limiting conclusions around differential outcomes. The second study was a RCT conducted through ECOG-ACRIN comparing the effectiveness of sustained video telehealth counseling plus free nicotine replacement therapy (NRT) medication (Virtual Sustained Treatment) to referral to standard Quitline tobacco counseling (Enhanced Usual Care) in assisting recently diagnosed cancer patients to quit smoking [18]. With a median age of 56 and a sample size of 306 patients, the telehealth group plus free NRT compared to enhanced usual care Quitline reported a significantly higher (P < .048) self-reported 7-day point prevalence abstinence at 3 months.
Most studies to date that examined remote smoking cessation treatment did not involve patients with cancer. An RCT study comparing phone counseling, which was delivered to patients in their homes, versus video counseling, which was integrated into primary care clinics, where patients needed to travel to the clinic, found no significant difference in biochemically verified 7-day point prevalence at 12 months [19]. While the counseling received was minimal, the primary significant finding was that more patients in the video arm had higher satisfaction and higher medication usage [19]. Another study that delivered remote service to rural residents of Australia found no significant difference between phone counseling and real-time video counseling in achieving 7-day point prevalence abstinence at 4 months, although patients reported greater satisfaction with the video counseling [20]. A pilot study of Korean-American women found that older women were less accepting of a video format compared to phone, but found no differences in 7-day point-prevalence at 3-months post-quit [21]. Only one study, which involved women living with HIV, found that participants in the video arm were more likely to report long term abstinent at the 6-month follow-up than those in the phone arm [22]. They also found that the video-call format was 30% less feasible than a phone call intervention for women in their 50’s and 60’s. Several limitations impacted the generalizability of these findings, including the small number of participants, the minimal amount of counseling delivered, and the high drop-out rate at the 6-month follow-up in the phone arm [22]. A review of the literature asserted that no evidence of a difference for smoking cessation existed between phone and video counseling using the strictest definition of long-term follow-up defined as prolonged abstinence at 3 months. [23].
Given the likelihood that relaxing requirements for establishing patient care through tele-health has increased access to tobacco treatment and the lack of evidence supporting a significant difference in effectiveness between phone and video modalities, the aim of this analysis is to examine differences in abstinence between patients who established care via real-time video intake consultations versus real-time phone intake consultations during the SARS-COV-19 pandemic at MD Anderson’s TRTP. All initial intake visits were conducted based on patients’ preference for either telephone or video. The vast majority of follow-up contacts were conducted by phone. The data were gathered from 5/1/2020 through 4/30/2021. Before March 2020, most patients at MD Anderson established care in person. In 2019, we began testing a Zoom real-time video application (Zoom Video Communications, Inc., San Jose, CA, USA) for conducting the initial consultation to eliminate barriers for patients who found travel to our clinic difficult. In mid-March, all in-person services were discontinued. Texas issued a telemedicine emergency rule March 14, 2020, suspending occupation code 111.005 (a)-(b) and title 22, chapter 174–6 (a) (2)-(3) thereby allowing medical professionals to establish physician-patient relationships, diagnose, order tests, and prescribe via phone and video. This presented an opportunity for a real-world examination of which modalities patients preferred and the corresponding outcomes.
2. Methods
MD Anderson Cancer Center’s Tobacco Research and Treatment Program (TRTP) was formed in 2006 with the primary mission to directly address the problem of continued tobacco use despite a diagnosis of cancer, and to expand the empirical basis for advancing the treatment of tobacco dependence among cancer patients and the general population. The TRTP operates as a center of clinical excellence and has continuously served patients, employees, and their family members since its inception, while also conducting extramurally funded clinical research with patients with cancer and community volunteers [24].
2.1. Patient recruitment
A total of 4,689 potential patients were identified. Patients who were proactively identified in the electronic health record as currently using tobacco or having recently quit made up most of the referrals (3,931; 83%). The next largest source of referrals came from provider referrals within MD Anderson (758; 16%).
Patients received a text message with brief program information and a more detailed message through their patient portal explaining the many benefits of quitting smoking for cancer patients. Tobacco treatment specialists trained in motivational interviewing made at least four initial calls to attempt to engage patients. Patients not reached were sent self-help materials, information on how to contact our program, and information related to the benefits of quitting. One final attempt to reach them by phone was made three months after the initial attempt.
2.2. Clinical Care and Follow-Up
The program offers three levels of intervention. The most comprehensive program (Level 3, in which 995 unique patients participated) provides integrated counseling and medication management. An additional 153 patients received a motivational counseling call from an experienced clinician. A motivational interaction, self-help materials, and a follow-up call (level 2) were provided to 1,421 patients. Self-help materials and a follow-up call (Level-1) were provided to 1,458 patients.
Comprehensive treatment (Level 3) involved consulting with both a counselor and medical provider to support the provision of fully integrated, evidence-based care [24]. The initial consultation (typically 45 minutes to one hour) was followed by 6–8 follow-up (typically 30 minutes) counseling sessions and a medication check with their medical provider three weeks into treatment. The sessions were flexible in number and type to meet the needs of the patient. Since the program’s inception, most follow-up appointments (counseling follow-up, medication checks, and long-term follow-up with support staff) have been conducted by phone. A pilot project in 2019 utilizing Zoom for the initial consultation was initiated to extend care to patients in their homes. Although most patients were still seen in person, we wanted to extend the option of completing the initial consultation from home for patients who found travel difficult or simply preferred it. Support staff provided check-ins prior to the appointment to ensure patients could use the ZOOM platform. Our experience with the Zoom pilot and the telemedicine emergency rule allowed us to transition seamlessly to 100% remote service in the middle of March 2020. For the entirety of the public health emergency patients have been given the option of establishing care via real-time video (Zoom) or by phone. The latitude to offer either phone or video provided information on preferences of several groups. For the initial consultation, patients self-selected their preferred method of establishing care.
2.3. Statistical Analysis
In this study, we employed bivariate statistics and logistic regression models to analyze the data collected from the TRTP during the SARS-COV-19 pandemic. The primary comparisons were made between patients who established care via phone consultations and those who opted for video consultations. For group comparisons, we used chi-square tests to analyze categorical variables and independent t-tests for continuous outcomes. To analyze the outcomes related to abstinence from smoking at three different time points (3, 6, and 9 months), we used logistic regression with models adjusted for age, gender, ethnicity/race, and the number of sessions attended. The logistic regression was conducted using Stata version 18, and we used a two-sided p-value of 0.05 for statistical significance.
3. Results
Patients smoked an average of 15 cigarettes per day for over 34 years. The most common cancer diagnoses were abdominal cancer, lung cancer, head and neck cancers, and breast cancer. Approximately 45% of our patients met criteria for one or more comorbid psychiatric diagnoses, with approximately 40% meeting criteria for more than one disorder. The descriptive statistics are summarized in Table 1. The gender distribution was similar between the phone (52.2% female) and video (55.2% female) consultation groups, with no statistically significant difference (p = 0.420). However, a significant difference was observed in race distribution between the two groups (p = 0.028). As shown in Table 1, participants in the phone group were more likely to be White (78.8%) compared to the video group (75.7%), while the video group had a higher percentage of patients categorized as other race (12.7%) compared to the phone group (7.1%). Additionally, there was a significant difference in age distribution between the groups (p = 0.001). Patients in the video group tended to be younger, with a higher percentage in the 18–34 (2.6%) and 35–49 (22.4%) age categories compared to the phone group. People who were 65 years and up were more likely to use the phone. The average number of sessions attended by patients in the phone group was significantly higher (mean = 7.7, SD = 4.1) than in the video group (mean = 6.8, SD = 3.7) (p = 0.005). The degree to which this difference is clinically meaningful since both groups received relatively high levels of tobacco treatment is unclear.
Table 1.
Patient characteristics by initial consultation groupa.
| Phone (N = 504) |
Video (N = 284) |
All (N = 788) |
P-value | |
|---|---|---|---|---|
| Gender | ||||
| Female | 263 (52.2) | 148 (55.2) | 411 (53.2) | 0.420 |
| Male | 241 (47.8) | 120 (44.8) | 361 (46.8) | |
| Race | ||||
| White | 397 (78.8) | 215 (75.7) | 612 (77.7) | 0.028 |
| Black | 71 (14.1) | 33 (11.6) | 104 (13.2) | |
| Other | 36 (7.1) | 36 (12.7) | 72 (9.1) | |
| Age category, y | ||||
| 10–34 | 6 (1.2) | 7 (2.6) | 13 (1.7) | 0.001 |
| 35–49 | 83 (16.5) | 60 (22.4) | 143 (18.5) | |
| 50–64 | 217 (43.1) | 115 (42.9) | 332 (43.0) | |
| 65 + | 198 (39.3) | 86 (32.1) | 284 (36.8) | |
| Insurance type | ) | <0.001 | ||
| Commercial | 1 (0.2) | 0 (0.0) | 1 (0.1) | |
| Embassy | 7 (1.4) | 1 (0.4) | 8 (1.0) | |
| Governmental other | 196 (38.9) | 140 (49.3) | 336 (42.6) | |
| Managed care | 6 (1.2) | 4 (1.4) | 10 (1.3) | |
| Medicaid | 2 (0.4) | 1 (0.4) | 3 (0.4 %) | |
| Medicaid managed | 10 (2.0) | 5 (1.8) | 15 (1.9) | |
| Medicare | 167 (33.1) | 82 (28.9) | 249 (31.6) | |
| Medicare managed | 86 (17.1) | 29 (10.2) | 115 (14.6) | |
| Self-pay | 29 (5.8) | 5 (1.8) | 34 (4.3) | |
| Missing | 0 (0.0) | 17 (6.0) | 17 (2.2) | |
| Number of sessions, mean (SD) | 7.7 (4.1) | 6.8 (3.7) | 7.4 (4.1) | 0.005 |
Values in table are number of patients (percentage) unless otherwise indicated.
Figure 1A and 1B show the utilization rates and the number of sessions by consultation modality, with chi-square test results indicating significant differences. Figure 1C and 1D illustrate the distribution of patients by age and gender across different consultation modalities, with significant differences identified through chi-square tests.
Fig. 1.
A: Percent of patients with phone vs video consultation utilization. B: Number of sessions by group. C: Percentages of patients who preferred video consultation, by age group. D: Percentage who preferred video consultation, by and gender (B).
Table 2 presents the abstinence rates by group, outcome, and time-point for self-reported 7-day point prevalence abstinence at the 3-month (End of Treatment-EOT), 6-month, and 9-month follow-ups. In the respondent-only rates, at the 3-month (EOT) follow-up, 41.19% (201 out of 488) of the phone group reported abstinence compared to 44.20% (122 out of 276) of the video group. At the 6-month follow-up, 46.63% (180 out of 386) of the phone group reported abstinence compared to 43.72% (94 out of 215) of the video group. At the 9-month follow-up, 37.50% (144 out of 384) of the phone group reported abstinence compared to 37.85% (81 out of 214) of the video group. In the intention-to-treat analysis, at the 3-month (EOT) follow-up, 36.71% (187 out of 504) of the phone group reported abstinence compared to 41.55% (118 out of 284) of the video group. At the 6-month follow-up, 33.53% (169 out of 504) of the phone group reported abstinence compared to 32.39% (92 out of 284) of the video group. At the 9-month follow-up, 31.55% (159 out of 504) of the phone group reported abstinence compared to 33.45% (95 out of 284) of the video group. None of these bivariate comparisons were significant. The logistic regression models (Table 3), adjusted for age, gender, ethnicity/race, and the number of sessions, showed no significant differences in abstinence outcomes at 3, 6, and 9 months between the phone and video consultation groups. As the 3 months odds ratio (OR) of abstinence between phone and video was 1.11 (95% CI: 0.80–1.54, p = 0.525). At 6 months, the OR was 0.88 (95% CI: 0.62–1.26, p = 0.482). At 9 months, the OR was 1.03 (95% CI: 0.73–1.45, p = 0.879).
Table 2.
Abstinence rates by group, outcome type, and time point for self-reported 7-day point prevalence abstinence at the 3-month (end of treatment), 6-month, and 9-month follow-ups.
| Phone | Video | |
|---|---|---|
| Self-report 7-day point prevalence abstinence | Abstinent/total (%) | Abstinent/total (%) |
| Respondent-only | ||
| 3 months | 201/488 (41.19) | 122/276 (44.20) |
| 6 months | 180/386 (46.63) | 94/215 (43.72) |
| 9 months | 144/384 (37.50) | 81/214 (37.85) |
| Intention-to-treat | ||
| 3 months | 187/504 (36.71) | 118/284 (41.55) |
| 6 months | 169/504 (33.53) | 92/284 (32.39) |
| 9 months | 159/504 (31.55) | 95/284 (33.45) |
Table 3.
Effects of group on abstinence at 3 time points (reference group=phone).
| Sensitivity analysis for unobserved confounding | |||||
|---|---|---|---|---|---|
| Abstinence | OR | 95 % CI | P-Value | OR | 95 % CI |
| Respondent-Only | |||||
| 3 months | 1.10 | [0.79, 1.53] | 0.568 | 0.98 | [0.7, 1.36] |
| 6 months | 0.89 | [0.62, 1.28] | 0.535 | 0.79 | [0.55, 1.14] |
| 9 months | 1.01 | [0.71, 1.43] | 0.952 | 0.9 | [0.63, 1.27] |
| Intention-To-Treat | |||||
| 3 months | 1.12 | [0.82, 1.54] | 0.467 | 1 | [0.73, 1.37] |
| 6 months | 0.94 | [0.68, 1.30] | 0.720 | 0.84 | [0.6, 1.16] |
| 9 months | 1.03 | [0.74, 1.42] | 0.878 | 0.92 | [0.66, 1.26] |
Note: models are adjusted for age, gender, race, no. of sessions, and insurance.
In the intention-to-treat analysis, the results were similar. At 3 months, the OR for abstinence was 1.14 (95% CI: 0.84–1.56, p = 0.394). At 6 months, the OR was 0.95 (95% CI: 0.69–1.30, p = 0.742). At 9 months, the OR was 1.03 (95% CI: 0.75–1.43, p = 0.841). This suggests that the modality of initial consultation (phone versus video) does not significantly impact abstinence outcomes, engagement, or patient demographics, except for some differences in age and race distributions.
4. Discussion
The SARS-CoV-19 pandemic ushered in the relaxation of multiple requirements for the delivery of care across multiple disciplines. The most notable was the expansion of telehealth care delivered directly to patients in their homes. The most pressing concern was how much this change would affect the service’s quality and ultimately the outcomes for patients. Our analysis of data collected in a naturalistic design found no difference in abstinence for patients whose treatment was delivered completely over the phone vs. those who received their consultation via video and follow ups over the phone. There was also no meaningful clinical difference in the degree of engagement between groups as evidence but comparable number of sessions between the groups.
Patients could select the initial consultation modality (phone or video). Almost all patients used the phone exclusively for follow ups, which was consistent with our practice prior to the pandemic. Older patients were more likely to request that all services be provided by phone, most likely due to ease of its use. This is consistent with studies of Medicare beneficiaries that found that older individuals had higher rates of audio only telehealth usage during the pandemic [25]. Older patients interested in video may need support staff assistance and/or family member assistance to support the set up and use of this newer medium of communication.
Our findings regarding the comparable efficacy of tobacco treatment delivered by phone exclusively vs video and phone are limited by the fact that this was not a randomly controlled trial. On the other hand, the naturalistic aspect of our data from a real-life setting offers a unique demonstration of what is possible to do, and the likely results. The complexity of factors affecting patients during the pandemic undoubtedly introduced additional variables that may have affected outcomes. Since our study ended in April of 2021, many patients have grown more comfortable with utilizing video formats. Our findings might not generalize to other geographical regions or to other less resourced cancer centers. Also, we only looked at telehealth for the initial consultation rather than the full course of treatment. Our follow-ups have always been conducted mostly by phone.
Despite this, our findings are consistent with the congressionally mandated report of telehealth during the public health emergency that ended on May 11, 2023, which showed little change in quality, improved access, and slight increases of cost to the Medicare system [25]. This conclusion was based on the review of services provided remotely across multiple disciplines and did not examine the difference between services delivered exclusively by phone vs video. Other reviews of telehealth found that in general telehealth exposure in primary care posed little risk to quality and may have improved care in the treatment of chronic disease management and preventative care such as tobacco counseling and medication intervention [26]. These broader based reviews of the efficacy of telehealth during the pandemic further support reviews of tobacco treatment via phone which found no difference in the efficacy of phone-based vs video-based tobacco treatment [23].
Perhaps the most important takeaway from the review of patient experiences during the pandemic is the fact that patients enjoyed expanded access to care without diminishing the quality of that care. This was true for our patients regardless of whether they established care via phone or via video. Establishment of care in our program included consultation with a physician or physician’s assistant and the provision of tobacco treatment medications. While telehealth may not be preferable when a physical exam is required, our findings suggest phone and video telehealth are appropriate and effective for the treatment of tobacco use disorder.
Our results do not diminish the preference many clinicians and patients may have for video visits over phone. When feasible, this modality more closely mirrors the in-person experience and has been shown to contribute to higher patients’ satisfaction [19]. The concern relates to disparities which can result from limiting access to care through modalities that some groups find challenging or complex [15]. Specifically, older adults, individuals with lower socioeconomic status and persons with severe mental health challenges may struggle to access needed care [27].
The pandemic revealed the many benefits and potential difficulties inherent to the provision of remote care. Both clinicians and patients reported a desire for continued access after the public health emergency [25]. The efficacy of tobacco treatment through telehealth is well established and the quality of both phone and video modalities for the provision of care has also been well established. Retaining clinicians’ ability to establish care for tobacco treatment whether by phone or video would ensure almost universal access to this essential medical service.
Acknowledgements:
The authors wish to acknowledge the contributions of several individuals in the MD Anderson Tobacco Research and Treatment Program, (TRTP) including Jennifer Ferguson, MSW, Leanne Witmer, LPCS, Nancy Huang, LPCS, Melissa Macomber, LPC, James Staley, LPCS, Elham Babaie, LPCS, Ludivina Velazco-Gutierrez, LPC, Christy Rose, LMSW, Tory Krieger, LCSW, Stephanie Orozco, LPC, Daniel Green, LPC, Larissa Farah, LPC Rudel Rymer, BS, Sheila Kitaka, PA and Aleah Waxali, PA, Monica Tortolero, BA, MHA, Erika Valenciana-Ruiz MBA, Marcia Lopez, BS, Rory Crossin, BS, Amanda Mendoza, BS, Ashleigh James, and Joy Neal for their contributions to the TRTP administration, patient care, coordination, clinical assessments, patient management, and data collection and management.
Funding Sources:
The Tobacco Research and Treatment Program at MD Anderson Cancer Center is supported by the State of Texas Permanent Health Funds awarded to the University of Texas MD Anderson Cancer Center. Dr. Cinciripini is partially supported by the Margaret & Ben Love Chair in Clinical Cancer Care in honor of Dr. Charles A. LeMaistre and the National Cancer Support Grant P30CA016672 to MD Anderson. Funders had no role in the conduct, design, analysis, or interpretation of this study. No outside compensation was received.
Conflicts of Interest:
PMC has received product support from Pfizer for NIH and CPRIT sponsored clinical trials. All other authors have no relevant conflicts of interest to disclose.
Footnotes
Informed Consent: This research was approved by the MD Anderson Institutional Review Board, Houston, Texas, as a database protocol with waiver of informed consent.
Human Rights: This research was approved by the MD Anderson Institutional Review Board, Houston, Texas, as a database protocol with waiver of informed consent.
Welfare of Animals: This article does not contain any studies with animals.
Data Availability:
Patient data collected from electronic health records will not be publicly available. Individual requests for anonymized data will be considered on a case-by-case basis with institutional approval.
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Associated Data
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Data Availability Statement
Patient data collected from electronic health records will not be publicly available. Individual requests for anonymized data will be considered on a case-by-case basis with institutional approval.