Evaluation of the Healthy Eating and Recovery Together (HEART) digital health intervention to support head and neck cancer caregivers and survivors

Introduction

The number of head and neck cancer (HNC) survivors with cancers of the larynx, oral cavity and pharynx is rapidly growing, with >500,000 survivors living in the United States currently (1,2). HNC survivors face numerous challenges after completing treatments, often including some combination of surgery, radiation and chemotherapy (3). HNC survivors routinely face significant treatment-related toxicities including xerostomia, dysphagia and mucositis plus challenges with speech, dental health, upper body mobility, body image and psychological distress (4-10). HNC caregivers, the informal, unpaid family members or friends of survivors (11), provide vital support and often shoulder—with minimal training and experience—complex and time-consuming responsibilities unique to HNC such as feeding tube management, food preparation, and communication assistance in addition to helping with emotional and practical concerns (12,13). Unfortunately, HNC caregivers experience significant unmet needs (13-15) and higher levels of distress when compared to both HNC survivors and population norms (16,17).

Interventions are critically needed at the end of treatment to support the vast and dynamic needs of HNC survivor-caregiver dyads (14,18,19); yet, barriers to meeting caregiver needs include cost, time constraints, inaccessibility of standard supportive care services, and low organizational support (20,21). To address the unmet needs of both HNC survivors and caregivers and address barriers to reaching caregivers specifically, our team turned to technology. Technology-focused HNC interventions have shown benefits in survivor recovery (22-27) and have shown promise in cancer caregivers yet have not been adequately tested in caregivers of survivors with HNC (28,29).

Guided by interdependence theory (30) and self-management principles (31,32) along with formative research with HNC survivors, caregivers and clinicians, we developed and piloted a digital health survivorship care planning intervention (33,34) that assesses needs and evaluates concerns of HNC survivors and caregivers during a routine follow-up visit after treatment completion. Information from the electronic needs assessment then guides the generation of personalized care plans to support dyads during post-treatment recovery. The intervention has high acceptability and feasibility, efficiently collects data from both HNC survivors and caregivers and effectively addresses HNC clinical and caregiving needs by generating algorithm-driven plans (33). However, despite high potential, caregivers reported that they prefer the intervention right at the end of treatment, and they desired additional information and resources specifically related to nutritional support. We therefore capitalized on mobile health technology and modified the digital care planning system to add a mobile support application (App) for caregivers to use as they transition home in the high-need recovery period. The new Healthy Eating and Recovery Together (HEART) intervention includes a digital health needs assessment that auto-generates a tailored care plan for dyads and an App for HNC caregivers. The goals of the HEART intervention are to support HNC caregivers’ roles in survivors’ recovery and improve both caregiver and survivor outcomes. The objectives of the current clinical trial were to evaluate the feasibility, acceptability, and short-term effects of HEART on our primary outcomes of unmet needs and depression and several secondary outcomes in HNC survivors and caregivers. We present this article in accordance with the TREND reporting checklist (35) (available at https://mhealth.amegroups.com/article/view/10.21037/mhealth-25-53/rc).

Methods

Study design

We used a single arm clinical trial design for this study. HNC survivors and caregivers completed a baseline survey followed by an in-person or virtual HEART intervention session and then caregivers used the App for 4 weeks. Survivors and caregivers completed a follow-up survey 6 weeks after the HEART intervention session. The study protocol was registered at ClinicalTrials.gov (NCT04552587). The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Institutional Review Board of the Medical University of South Carolina (No. Pro00066211). All participants signed informed consent forms in person or over videoconference platform.

Study participants

Survivors were recruited near the end of radiation therapy at a southeastern National Cancer Institute-designated cancer center using a mailed invitation letter followed by a call. These participants included individuals with stage I–IVB HNC (larynx, lip/oral cavity, pharynx, salivary gland, nasal/paranasal sinus, cutaneous) who received radiation therapy with or without surgery and/or chemotherapy; experiencing nutritional or intake challenges as measured by a 6-item screener; and co-habiting with nominated caregivers who provided “hands-on” care during treatment. Participants were recruited between 2 weeks before completing radiation and up to 2 months after completing radiation. For both survivors and caregivers, individuals were excluded when they had cognitive challenges, did not have a smartphone or did not speak English. Potential survivors were mailed a study introduction letter, completed screening by telephone and nominated their primary caregiver. Survivors and caregivers each completed questionnaires online; gift cards were received after completing surveys and the HEART session. Data were collected from December 2020 to August 2021.

HEART intervention

Overview

The HEART intervention (33,34) (see Figure 1) was planned to include a one-time in-person dyadic session with survivors and caregivers that includes an electronic needs assessment for each dyad member followed by education about survivorship and the delivery of a written care plan tailored based on the concerns endorsed by survivors and caregivers. Finally, caregivers received training on the HEART App in this in-person session and used the App for 4 weeks at home. The COVID-19 pandemic disrupted the planned in-person digital health clinic study procedures, so we developed the option of a virtual version offered over telehealth; all in-person intervention content including the electronic needs assessment, tailored care plan, education and App training, was maintained and remained consistent in the virtual option.

Figure 1 HEART mobile App components. A mobile App includes educational tips and encouragement, recipes, a nutrition tracker, videos and bi-weekly text notifications with check-ins and resources about well-being and nutrition. App, application; HEART, Healthy Eating and Recovery Together.

Technology

The HEART system platform is an enterprise data management system that is a HIPAA-compliant care planning system with an administrative interface to build needs assessment surveys, resource libraries and logic lines, a personalized care plan generation tool and an Android or iPhone compatible App. A proprietary web-based content management system (CMS) provides a secure interface to develop and manage content, validate data entry, use import/export procedures, build surveys and care plans with branching logic and run reports. A touchscreen tablet device provides a web-based interface for data collection with customized font, and images. Based on administrator-designated logic, the system generates a care plan with a tailored summary of diagnosis, treatment and care team details, followed by tailored messages, referrals and educational materials mapped to the endorsed concerns of survivors and caregivers. The HEART system’s logic was built in the HEART planning phase with our team of researchers and clinicians and this logic for each needs assessment item guides tailored content for each care plan. For example, if a survivor reports concern about cancer recurrence, the care plan will include messages, educational materials and a referral to support these concerns with messages for both survivors and caregivers about cancer recurrence uncertainty.

Needs assessment

To guide the content of a tailored care plan, the electronic needs assessments were completed by tablet computer in the clinic or online in the virtual session. The needs assessments (34) involved asking survivors and caregivers about their unmet needs, distress, symptom management, fear of cancer recurrence, nutritional challenges, smoking status and alcohol intake. We also assessed symptom severity and weight change over the past two weeks in survivors and concern about caregiving tasks and burden in caregivers (34).

Tailored care plan

Based on algorithms designed by our clinical advisory board in previous research (34), the needs assessments drove automated, tailored, printed care plans based on the concerns endorsed in dyads. A printed binder was assembled with the care plan comprised of personalized messages and tips, educational materials and recommended referrals. Messages included educational tips and encouragement around each concern endorsed. For example, if a survivor endorsed dry mouth, the care plan provided messages for both the survivor and caregiver around management of dry mouth and tips for supporting a loved one with dry mouth. After the needs assessments were completed, a master’s level interventionist provided in person or virtual education about the transition from treatment to the post-treatment period, the importance of teamwork in dyads and the importance of follow-up care and communication with clinicians. Next, a nurse spoke with survivors and caregivers in person or virtually about their clinical concerns and recommended referrals. After encouraging referral uptake, then nurse made those referrals that the participants accepted. The last part of the session was just for caregivers and included a video about nutritional support and App training delivered in person or virtually. The printed binder was provided to the participants in the clinic after the session or mailed to those participating virtually.

Caregiver mobile App

The App provided resources in five broad areas, including nutritional support, nutrition tracker, caregiver toolkit, support videos from other HNC dyads and clinicians and a My Resources section to store an electronic version of the care plan and other personalized resources (Figure 1). Finally, the App was designed to provide twice weekly check-in notifications for caregivers with one question to assess their primary concern about their own well-being for the first check-in and one question to assess their primary concern about their loved one’s nutrition for the second check-in. Four options were provided for each question and real-time resources, including messages, videos, recipes and resources, were provided matched to the response.

Measures

Feasibility

The study interventionist completed logs for each session about the HEART intervention delivery, including protocol steps completed, number of minutes in length for each component (i.e., needs assessments, meeting with nurse, and App training), number of messages and educational materials generated on care plan, and number and types of referrals flagged with referral status outcomes (declined or accepted). App use monitoring included data analytics about the number of times logged into the App, which App menu sections and sub-sections were visited and response to bi-weekly notifications.

Acceptability

Immediately after the HEART session, nurses reported on their perception of whether the survivor and caregiver were engaged in the session, understood the care plan and were prepared for next steps in cancer care (1= not at all to 4= very much). Also, in the follow-up survey at 6 weeks, survivors and caregivers reported their beliefs about the extent to which (I) the information provided was practical and helpful to them emotionally (1= strongly disagree to 6= strongly agree) and (II) the session made them feel prepared for the follow-up period. Participants also rated the session timing (preferred earlier, just right or preferred later). In addition, participants reported whether they reviewed the binder later or shared them with others. Finally, App acceptability was measured using the System Usability Scale (SUS) (36) with 10 total items about ease of use, complexity, integration and interest. The SUS is a validated measure with summary scores ranging from 0 to 100, with higher scores reflecting higher acceptability (36). App acceptability was also assessed using 3 items to evaluate whether the App helped caregivers provide care to their loved one, helped their emotional well-being and provided practical tips, and 1 item to evaluate whether the amount of information provided in the App was appropriate (1= strongly disagree to 6= strongly agree).

Primary outcomes

Unmet needs were assessed in survivors and caregivers at baseline and follow-up using an adapted version of the Cancer Survivors/Partners Unmet Needs instruments (37,38). Respondents rated 30 items concerning whether they currently needed help with information, quality of life, existential survivorship and relationship issues (yes or no). The total number of unmet needs was calculated.

Depression was assessed in survivors and caregivers at baseline and follow-up using the Patient-Reported Outcomes Measure Information System (PROMIS) short-form 8a instrument (39,40). Participants rated the extent to which they were feeling hopeless, helpless, depressed and worthless in the past 7 days from 1= never to 5= always. Total raw scores for each participant were translated into standardized t-scores with higher scores reflecting higher depression. Cronbach’s alphas in the current study sample were 0.94 for survivors and 0.93 for caregivers at baseline.

Secondary outcomes

Caregiver burden was evaluated at baseline and follow-up using a 4-item screening version of the Zarit Burden Inventory (41). Scores range from 0 to 16; higher scores represent greater burden. Cronbach’s alpha in the current study sample was 0.80 at baseline.

Dyadic coping was assessed at baseline and follow-up using a 5-item modified cancer-specific version of the dyadic coping subscale of the Dyadic Coping Inventory (42). Participants reported the frequency (1= never to 5= always) with which they engaged in dyadic coping efforts (e.g., engaged in serious discussions about cancer, tried to cope with problems related to cancer together). Cronbach’s alphas in the current study sample were 0.93 for survivors and 0.98 for caregivers at baseline.

Nutritional status satisfaction was assessed at baseline and follow-up using a single item evaluating survivor and caregiver satisfaction with their/their loved one’s nutritional status. The response set ranged from 1= extremely satisfied to 5= not at all satisfied. Higher scores reflected lower satisfaction.

Symptom severity was assessed in survivors at baseline and follow-up using the MD Anderson Symptom Inventory (MDASI) (43,44). The MDASI includes 13 cancer-specific symptoms and 9 HNC-specific symptoms rated on a scale from 0= not at all to 10= as bad as you can imagine. The 22 items were averaged and the Cronbach’s alpha at baseline was 0.89.

Symptom distress was assessed using a single item in survivors and caregivers at baseline and follow-up to evaluate how distressing one’s/loved one’s symptoms are. The response set ranged from 0= not at all distressing to 10= extremely distressing.

Sociodemographic, caregiving and clinical characteristics

We assessed participants’ age, sex, race, ethnicity, and years of education. Caregivers reported relationship type and days per week and hours per day providing care. We assessed survivors’ cancer site, cancer stage and treatment type using chart review.

Statistical analysis

Participant characteristics were summarized using descriptive statistics as were feasibility and acceptability. To examine whether the change in primary outcomes (unmet needs, depression) and secondary outcomes (caregiver burden, dyadic coping, nutritional status satisfaction, symptom burden, symptom distress) from baseline to 6-week follow-up was different from zero , average scores and 95% confidence intervals (CI) were calculated at each time point and we used paired t-tests or Wilcoxon signed-rank tests to test for differences. Finally, descriptive statistics were used to explore participant use of and satisfaction with the intervention. R for Statistical Computing was used for all data analyses (45).

Results

Participant characteristics

As shown in Figure 2, we mailed letters to 122 survivors approaching the end of radiation. Eighty-nine (73%) were reached for screening and 22 (25%) of those screened were ineligible with the most common reasons being having no caregiver (n=5), having no smartphone or computer for study activities (n=5), a clinical reason (n=5) or having limited nutritional challenges (n=5). Of the 67 survivors who were eligible, 12 (18%) declined due being too ill or overwhelmed, 29 (43%) declined because they were not interested, and 26 (39%) enrolled. Twenty-three dyads (88%) completed the study.

Figure 2 CONSORT diagram.

As reported in Table 1, the average age for survivors was 63 and 70% were male. Most survivors were white (83%) with some college education or more (82%). A wide array of cancer types were represented with the most common being human papilloma virus (HPV)-positive oropharynx (30%) and oral cavity (20%) cancers. All participants had radiation therapy with 70% also having surgery and 48% also having chemotherapy. The majority (74%) of nominated caregivers were partners, 78% were female and the average age was 59 years. Eighty-three percent of caregivers reported providing care every day with more than half (56%) providing 1–4 h of care per day.

HEART feasibility and acceptability

Feasibility

As shown in Table 2, 100% of dyads completed the HEART session (average length =51 min) and most participants (78% of dyads) completed the session virtually. While most session elements were completed for all sessions, the nurse care plan discussion was missed for 4 (17%) dyads. Missed nurse sessions were all in the context of virtual sessions (22% of virtual sessions). Generated care plans included an average of 34 tailored messages with the most common messages (≥70% of care plans) addressing sleep, dry mouth, mucus, sense of taste, identity after treatment, recurrence worry, making time for self, nutritional satisfaction, maintaining weight and monitoring symptoms (data not shown). Top referrals recommended in the session included behavioral medicine (100%), nutrition (96%), speech (57%) and maxillofacial prosthodontics (39%). Some referrals were not relevant because the participant was already seeing a provider for maxillofacial prosthodontics (67%), speech (54%), physical therapy (40%) and nutrition (36%). Referral acceptance rates ranged from 0% (speech, maxillofacial prosthodontics, social work) to 34% (physical therapy), 35% (behavioral medicine), 36% (nutrition), 50% (financial counseling) to 67% (chaplain and smoking cessation; Table 2). The most common reason for declining a referral behavioral medicine was disinterest.

App use varied widely across participants (Table 3). Caregivers logged into the App an average of 20 times in 4 weeks and 17% continued using the App after completing the final 6 week survey. The nutritional support and caregiver toolkit sections were visited most. Fewer than half (48%) used the nutrition trackers and use of the three different tracker types varied. In those using the nutritional support section (91%), the majority used the recipes (65%) and tips for common issues (57%). In those using the caregiver toolkit (83%), over half used the caregiving tips information (52%) and the relaxation techniques (57%). Videos were watched by nearly half (48%) of caregivers, but small numbers visited each of the 10 videos. Finally, the majority (57%) reviewed their clinic care plan in the My Resources section.

Caregivers responded to notification prompts by answering the prompt question for 62% (114/184) of the check-ins. Response rates varied over time with missed prompts for well-being support spanning 30–48% across weeks and missed prompts for nutritional support spanning 17–61% across weeks. As shown in Figure 3A, in those responding to notifications, caregivers varied in their endorsement of well-being concerns over the 4-week prompting period, with emotional well-being most commonly endorsed at week 1 and rates of endorsement declining over time. Modest levels of concern (13–17%) about managing caregiving tasks, taking care of their own health and working together with their loved one were found at week 1, with only concern about working together increasing over time. As shown in Figure 3B, responses to primary nutrition concerns at weekly check-ins also varied with pain and discomfort being most highly endorsed at week 1 and rates of endorsement decreasing over time. Taste and smell concerns were endorsed by 26% of respondents at week 1 and remained fairly stable over time. Weight loss and feeding tube challenges were endorsed least commonly and also varied across time.

Figure 3 Caregiver primary concerns at weekly check-in. (A) Concerns about well-being. (B) Concerns about nutrition.

Acceptability

Dyads were in moderate to strong agreement that the care plan made them feel prepared for next steps in cancer care (78% survivors, 78% caregivers), that the information was helpful to their emotional well-being (74% survivors, 68% caregivers) and that the amount of information was appropriate (78% survivors, 87% caregivers). The majority of survivors (74%) and caregivers (87%) used the care plan and binder after the session, but few shared the care plan and binder with family or providers (30% survivors, 17% caregivers). While 57% of survivors reported that the session timing in their cancer care was just right, 43% preferred earlier intervention. Caregivers varied in their opinions about timing with 39% reporting the timing was just right, 48% preferring earlier and 13% preferring later.

Nurses also reported high acceptability, rating the sessions favorably (% quite a bit or very much) for the appropriateness of the session length (94%), caregivers’ engagement (94%) and survivors’ engagement (92%). Nurse ratings were also high (% quite a bit or very much) for dyads’ understanding of the care plan (100%) and whether the care plan would help them be prepared for next steps in cancer care (95%).

The App was also rated highly in follow-up surveys. Caregiver reported an average system usability of 75.3 (range, 20–98, on a scale from 0-100 with higher scores indicating higher satisfaction). Caregivers reported agreement that the support received through the App helped them provide care to their loved one (86%), was helpful to their emotional well-being (78%), provided practical tips (91%) and provided the appropriate amount of information (82%).

Outcomes

For primary outcomes, as highlighted in Table 4, unmet needs remained stable from baseline to 6-week follow-up in both survivors (P=0.49) and caregivers (P=0.30). Depressive symptoms decreased over time in survivors (P=0.03) but remained stable over time in caregivers. For secondary outcomes, caregiver burden in caregivers (P=0.23) and dyadic coping in caregivers (P=0.71) or survivors (P=0.26) did not change over time. Nutritional status satisfaction increased over time in caregivers (P=0.02) and marginally in survivors (P=0.07), symptom severity decreased in survivors (P=0.005) and symptom distress did not change over time in survivors or caregivers.

Discussion

The growing population of HNC survivors (1,2) face significant challenges at the end of treatment including challenges such as speech, dental health, neck and shoulder mobility, body image and psychological distress (5,7,9,10,46) and their caregivers therefore have a unique composition of caregiving tasks and a high degree of caregiver burden (12,14,17). There are multiple barriers to addressing survivor and caregiver unmet needs at the end of treatment as care patterns change (3), dyads experience multiple stressors, survivors have ongoing and complex needs and resources to meet their needs may be limited (12,21,47,48). Other barriers can include time constraints, access to supportive care services, and other costs (20,21). Technology-enabled interventions (49-52) hold promise for overcoming some of these barriers to reach HNC dyads and provide them with needed resources and tools to promote a positive recovery.

To address documented gaps in care planning at the end of treatment, we developed the HEART intervention with an emphasis on using electronic needs assessments in both HNC survivors and their caregivers to drive tailored educational support, referrals to supportive care services for dyads and an App to use at home for caregivers. The HEART intervention provided an array of print, electronic, and mobile App components, plus an in-person or virtual session with a nurse. The intervention was developed to assess and address multiple unmet needs from both survivor and caregiver perspectives (e.g., symptom severity and caregiver strain, respectively). This study primarily aimed to evaluate HNC survivors and caregivers’ perceptions and uptake of the HEART intervention, and we found strong evidence of its feasibility and acceptability among both HNC dyads and nursing staff.

Feasibility was demonstrated by high adherence to care planning sessions with 100% of both survivors and caregivers attending the session and completing most of its components (i.e., needs assessment, discussion of recovery and challenges, nutrition video, and App training). Reflecting the literature suggesting a high level of unmet need and challenges among HNC survivors and their caregivers (3,12,14,53), a substantial number of referrals were recommended based on the needs assessments. However, the nurse-led discussion of these personalized referrals was missed for 17% of sessions, likely due to the challenge of delivering this component online. Importantly, as the coordination of referrals to link dyads to care is critical for supporting timely recovery, this HEART element may be better suited to in-person delivery in the context of routine follow-up care, as we initially planned. Consistent with other intervention research studies during the pandemic (54,55), our protocol was modified and nursing staff frequently joined the session remotely, and challenges with timing sometimes arose as nurses had to manage competing demands within the clinic.

Feasibility was also demonstrated by the length of the care planning session and the content of care plans as the overall sessions lasted on average under one hour and the messages, materials and referrals matched typical post-treatment challenges in HNC dyads (3,12,14,53). While participants were already commonly seeing a specialist for some referrals, including maxillofacial prosthodontics, speech, physical therapy and nutrition, nurses were able to reinforce the value of the recommended services for these participants and encourage care adherence and this could be beneficial as survivorship care can be fragmented (56). In the current study, Behavioral Medicine was declined for 50% of the referrals due to disinterest. This finding is consistent with literature highlighting multi-level barriers to depression treatment referral uptake such as stigma, transportation, lack of understanding about what treatment is and how it can help (57-63); these barriers may need to be proactively addressed when making a referral to Behavioral Medicine in future iterations of the HEART intervention.

Also pertinent to feasibility, the average use of the App was approximately 20 times in the 4-week use period with survivors commonly visiting the sections with content matching the most prevalent early post-treatment recovery concerns (i.e., nutrition) (8,64-66). Caregivers most commonly visited the caregiver toolkit with caregiving tips and resources related to their own well-being. This is promising as cancer caregivers often overlook their own health when serving as caregivers (11,15,16), and the well-being of caregivers can impact not only the quality of care they provide but their experience of burnout. However, because only half of caregivers used the peer and clinician videos and only close to two-thirds responded to the twice weekly notifications, caregivers may need additional reminders to support the use of these features. Aligned with previous studies finding suboptimal engagement with digital health interventions, our study showed some positive and some negative engagement metrics, so more research is needed to design more active strategies for engagement (67-69) with the HEART App such as setting use goals, earning “badges” for meeting those goals, and pushing different types of reminders when goals are unmet.

High acceptability was reported by survivors, caregivers and nurses for the HEART intervention. The majority of survivors and caregivers perceived that the care plan helped prepare them for next steps in their cancer care, provided sufficient information and was helpful to their emotional well-being. Nursing staff also reported that dyads showed good understanding of the care plan and demonstrated high engagement in the session. While the majority of survivors thought the timing of the HEART session in their cancer care was just right, more caregivers preferred earlier intervention. This suggests that many caregivers faced challenges before accessing the intervention that were perceived to have been better addressed with the assistance of the App. As caregivers often report feeling unprepared for their roles and challenged by care transitions (11,14), they may need earlier intervention that is focused on preventing and managing common problems while survivors may benefit from additional intervention later where they, along with their caregivers, learn how to cope with newer or persistent concerns. Caregivers also rated the App favorably, reporting that the App helped them provide care for their loved one.

Finally, to guide next steps in intervention development, we monitored change in a set of outcomes in dyads over a brief follow-up period. While we were not powered to detect differences, none of the outcomes we evaluated worsened in the first 6 weeks following treatment, which is what commonly occurs in HNC (19,53,70,71) and we observed declines in depression and symptom severity in survivors and improved nutritional satisfaction in both survivors and caregivers. These findings merit additional research in a larger evaluation of the HEART system.

This study has multiple limitations. This study included only one site at an academic medical center and our sample size was modest. Like many dyadic studies, recruitment can be challenging and over half of those who screened eligible for this study indicated they were not interested or were too ill or overwhelmed to participate. While these decline rates are comparable to other dyadic intervention clinical trials (72,73), the COVID pandemic also further challenged recruitment. While our final sample demonstrated diversity in clinical characteristics, it was comprised mostly of participants who were white with some college education and caregivers were co-habiting and required to have a smartphone, so HEART should undergo testing with a more diverse sample in the future. Also, our follow-up timepoint was brief, potentially limiting our ability to observe effects on outcomes. Despite these limitations, we developed and tested a multi-component intervention, used validated instruments and examined multiple domains of acceptability, feasibility and short-term effects of HEART.

Conclusions

In summary, the HEART intervention demonstrated favorable feasibility and acceptability in this study. Interventions for HNC dyads are critically needed to address dynamic recovery and caregiving challenges and with further enhancements to streamline the HEART multi-component intervention and its delivery timing and engagement strategies, the HEART intervention merits further study in a larger randomized controlled trial.

Acknowledgments

The authors wish to acknowledge Jama Olsen’s efforts in recruitment and data collection for this study.

Footnote

Reporting Checklist: The authors have completed the TREND reporting checklist. Available at https://mhealth.amegroups.com/article/view/10.21037/mhealth-25-53/rc

Data Sharing Statement: Available at https://mhealth.amegroups.com/article/view/10.21037/mhealth-25-53/dss

Peer Review File: Available at https://mhealth.amegroups.com/article/view/10.21037/mhealth-25-53/prf

Funding: This work was supported by the National Cancer Institute (grant No. R21 CA173271) with support from the South Carolina Clinical and Translational Research Institute (UL1 TR000062) and the Biostatistics Shared Resource of the Hollings Cancer Center (P30 CA138313).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://mhealth.amegroups.com/article/view/10.21037/mhealth-25-53/coif). K.R.S. was Principal Investigator for a 2-year grant of the National Cancer Institute funded to the Medical University of South Carolina. And this grant funded the study for this manuscript. B.T. reports that he testifies on behalf of plaintiffs who have filed litigation against the tobacco industry. E.M.G. reports having received research support and personal fees from Castle Biosciences; research support and travel from Stryker; and consulting and travel for Merck, all outside of the submitted work. The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Institutional Review Board of the Medical University of South Carolina (No. Pro00066211). All participants signed informed consent forms in person or over videoconference platform.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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