Because cancer disrupts their physical, emotional, and social development during a critical period in their life, young adult cancer survivors (YACS) are particularly vulnerable to treatment late effects, including insomnia [1-8]. Insomnia is commonly mistakenly viewed by patients and providers “as a temporary reaction to the cancer diagnosis or treatment” [9], with few long-term consequences. However, insomnia frequently develops into a debilitating chronic condition. As many as 1 in 4 YACS experience significant insomnia many years after cancer treatment has ended [5-7,10]. Chronic insomnia is associated with significant health problems in the general population, including heart disease, obesity, hypertension, diabetes, depression, and anxiety [11-20]. Because of their medical history, YACS are already vulnerable to many of these health conditions, making access to effective insomnia treatment critically important to their overall health [21-23].

Cognitive behavioral therapy for insomnia (CBTI) is a well-established and empirically supported treatment. CBTI is the recommended first-line treatment by the American Academy of Sleep Medicine and American Colleges of Physicians for insomnia disorder in adults [24,25]. Multiple randomized trials have demonstrated CBTI is the most effective long-term insomnia treatment, even compared with pharmacotherapy [26-28]. A review of CBTI for cancer survivors similarly concluded it “provides significant, lasting improvement” [29].

Unfortunately, CBTI is largely unavailable to the growing population of YACS who need it [30,31]. To make CBTI widely available to YACS, several barriers need to be resolved, including the shortage of trained CBTI providers [32,33], the patient burden of standard CBTI regimens [34-36], and the lack of CBTI interventions specifically targeting the needs of YACS. Moreover, as YACS’ access to effective insomnia care is limited by geography and other factors [30,31,33,37-39], it is imperative CBTI be made more accessible to them in their communities.

To address these challenges and deliver effective insomnia treatment to YACS, we developed the Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA). STEP-YA is a brief, low-intensity intervention presenting core elements of CBTI in an online educational format. Delivered in a 90-minute, 1-on-1, instructor-led session, STEP-YA educates YACS about causes of insomnia after cancer, including developmental, social, and health factors affecting YACS, and introduces them to CBTI principles and methods. During the synchronous (live) online session, survivors review their current sleep habits and consider alternative strategies consistent with CBTI recommendations. The standard elements of CBTI are presented in STEP-YA but with modifications previously shown to maintain efficacy while reducing treatment demands [40]. Additionally, information particularly salient to the experience of YACS was added, including information about how cancer diagnosis and treatment impact sleep and how to deal with young adult stressors (ie, fear of missing out, disconnecting). Following a self-management approach, the instructor provides guided behavioral planning, encouraging survivors to develop an individualized sleep action plan they will implement after the session.

The STEP-YA intervention is designed to address barriers to insomnia treatment for YACS because it is brief, low-cost, low-burden, and targets their specific needs and experiences. Delivered virtually, STEP-YA is available to YACS when and where they need it, without requiring travel to a specialized insomnia treatment site. As a self-management intervention, STEP-YA supports YACS’ autonomy by helping them make informed choices to manage their own insomnia [41], without taking the prescriptive stance commonly found in behavioral therapies. The efficacy of STEP-YA is currently being evaluated in a clinical trial described here. The primary aims of the study are to (1) test the hypothesis that STEP-YA improves insomnia symptoms (primary outcome) and mood (secondary outcome) in YACS and (2) determine if improvement in these outcomes is superior in the coaching condition compared with the noncoaching condition. A secondary aim of the study is to explore participant variables associated with clinically significant response to the STEP-YA intervention.

Guided by the Obesity-Related Behavioral Intervention Trials (ORBIT) model for development and early testing of behavioral interventions [42-44], the STEP-YA intervention is being evaluated in an early-stage (phase 2A) randomized clinical trial. Participants are randomized (1:1) to receive the STEP-YA intervention either (1) alone (noncoaching condition) or (2) with the addition of 2 remote coaching sessions (coaching condition). STEP-YA sessions are delivered online via live videoconference. Outcomes are assessed at baseline and again 4 weeks and 8 weeks postbaseline. Participants are off-treatment YACS recruited from treatment centers, advocacy groups, and social media and will complete all study activities remotely.

Prior to study activation and participant enrollment, the study protocol was approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board (Protocol 21-613).

Participants will be 74 off-treatment YACS aged 20 years to 39 years. To be eligible for enrollment, YACS were diagnosed with cancer (excluding nonmelanoma skin cancer) at least 1 year prior, have received no cancer therapy (excluding chemoprevention) in the prior 4 months, and have no additional cancer therapy planned. Additionally, participants must be able to read and write in English and have significant insomnia as evidenced by an Insomnia Severity Index (ISI) ≥12 [45]. YACS who have specific conditions, medications, or past insomnia treatments that may affect their sleep or response to STEP-YA are excluded; these inclusion and exclusion criteria are detailed in Table 1.

Recruitment materials and procedures are designed to allow YACS to self-refer to the study. These materials include a brief informational video, study information sheet, outreach letters and emails, informational postcards, and brief study descriptions suitable for posting on patient-facing materials distributed by patient support and advocacy groups. All materials provide phone, email, and web contact information for YACS interested in learning more about the study. Examples of these can be seen on the study website [46].

To distribute these materials to potentially eligible YACS, several methods are used. At our cancer center, recruitment postcards are placed in patient waiting areas, and study information appears on hospital screens presenting information and notices to patients. Clinical providers are informed of the study and given recruitment information and materials. In several cases, providers have granted permission to send recruitment letters directly to their eligible patients. Programs that serve supportive care needs at the center are also asked to include study information in their newsletters, emails, or social media posts. Following similar procedures, recruitment information and materials have been shared with providers at several other cancer centers in the United States. Outside of cancer centers, these materials are also posted on research portals, posted on social media sites (ie, Facebook, Instagram, Reddit), and provided to patient advocacy and support groups (regionally and nationally) for distribution to their members.

Outcomes for the trial are change in insomnia symptoms as measured by the ISI (primary) and change in mood symptoms as measured by the Profile of Mood States Short form (POMS-SF; secondary) [64]. In addition to these scales, measures of demographic and health variables are included, as are measures of participant experience and satisfaction with the intervention. Details of all measures and time points they are given are included in Table 2.

Aim 1 of the study will be addressed using a within-subjects analysis including all participants to determine if the STEP-YA intervention is associated with significant changes in outcome measures (insomnia and mood) over time. Aim 2 will be addressed using 2-way analysis of variance with 1 between-subjects factor (coaching vs noncoaching) and 1 within-subjects factor (time) and an interaction term.

To address the secondary exploratory aim, logistic regression analysis will be used to identify participant factors associated with a clinically significant response to the STEP-YA intervention. Analyses will attempt to identify demographic and sleep factors (eg, age, severity of insomnia symptoms) associated with a reduction of ISI scores ≥6 points at 8 weeks. Variables identified in univariate analysis (P<.10) will be entered into a multivariable model estimating STEP-YA response from baseline variables. Analyses will explore these relationships separately in the 2 study arms; pooled analyses including participants across arms will be conducted if univariate analyses indicate the relationships of predictors and outcome are consistent.

To meet study aims, we require 64 participants with evaluable data but will enroll 74 as a hedge against attrition. Our prior single-session educational interventions have demonstrated large effects on insomnia symptoms of d≥1.00; the study is conservatively powered to detect an effect size of .52 (primary aim). With sample size of 64 (32 per arm), the study will have 80% power to detect an effect of this size within each arm (α=.05). To compare the relative improvement in the primary endpoint between arms, 64 subjects will have 80% power to detect a difference of d=0.62 between arms (α=.05, 1-sided).

Enrollment began in November 2022. As of September 2023, 30 participants had been enrolled. We anticipate recruitment will be completed in 2024.

STEP-YA was developed to meet YACS’ need for effective behavioral insomnia treatment by addressing the low completion rates and lack of access to care common to standard CBTI treatment [30,37,65] and by targeting developmental, social, and health factors that affect their sleep. As a low-intensity intervention, STEP-YA is not intended to completely replace intensive CBTI treatment, which some YACS likely require. Rather, by meeting the needs of the majority of YACS for whom standard insomnia treatments are not appealing, not needed, or currently not available, STEP-YA aims to reduce treatment barriers and avoid potential overtreatment. Though adapted from 2 previously tested brief behavioral interventions for insomnia with cancer survivors [40,66], STEP-YA is a novel intervention as yet unsupported by clinical testing. As recommended in the ORBIT model for development and testing of novel behavioral interventions [42-44], this trial will provide the first empirical evidence evaluating the efficacy of STEP-YA. Study results will help determine whether evidence of efficacy is sufficient to warrant future trials of the existing STEP-YA intervention and aid in the design of future trials investigating its clinical effectiveness in clinical practice. Additionally, results will help to identify subgroups of YACS most likely to benefit from STEP-YA and help to determine whether individualized coaching or other efforts to further optimize the intervention are warranted. We anticipate that data supporting the efficacy of STEP-YA would lead to Phase 3 efficacy trials of STEP-YA in larger and more diverse populations. In addition, positive trial results would also support implementation research into the potential to deliver STEP-YA in small groups and in collaboration with existing survivor advocacy and support groups, which could increase access to insomnia treatment for YACS.

Conceptualized within the ORBIT model, this early (stage IIa) trial is designed with a limited scope; it is not intended to conclusively evaluate the efficacy of STEP-YA but to determine if preliminary evidence supporting “proof of concept” for STEP-YA is sufficient to warrant continued efficacy research. As such, the trial design has several notable limitations. Without a control group, study results cannot evaluate how much the observed trial effects are due to natural changes over time or nonspecific effects associated with trial participation. With a modest sample size of English-speaking participants, data on how demographic, cultural, and other participant variables moderate the effects of the intervention will be limited. Similarly, the study will not be able to shed light on any long-term effects of the intervention for participants beyond the 8 and 16-week time points.

Despite these limitations, the trial is well-positioned to provide new and clinically relevant information regarding insomnia interventions for YACS. STEP-YA represents a significant innovation in behavioral insomnia treatment for YACS by delivering a self-management intervention that is less demanding than standard CBTI and attends to YACS specific concerns. In addition, by using nonclinician interventionists to deliver the intervention synchronously online, it aims to overcome logistical barriers and increase access while avoiding uptake and adherence challenges common to asynchronous insomnia interventions [38,67-70]. Investigating the efficacy of this approach is critical for evaluating the potential utility of the STEP-YA intervention and for the potential of applying these intervention methods to address other behavioral needs in this vulnerable population.

It is well known that behavioral treatment significantly reduces insomnia symptoms but only for those who can access it, which most YACS cannot [30,31]. Our work aims to provide YACS access to empirically supported behavioral insomnia treatment by developing and testing a brief, low-intensity intervention that addresses their needs and interests and can be delivered to them wherever they have internet access. If shown to be effective, this approach has the potential to greatly improve access to the growing population of YACS whose health and quality-of-life are affected by insomnia.

The data sets generated and analyzed during this trial will be available from the corresponding author on reasonable request following completion of the trial and publication of the main outcomes.