Caregivers' Internet-Delivered Insomnia Intervention Engagement and Benefit: SHUTi-CARE Trial Primary Quantitative Analysis.

BACKGROUND: Delivering insomnia treatment by the Internet holds promise for increasing care access to family caregivers, but their ability to adhere to and benefit from such fully-automated programs has not been rigorously tested. PURPOSE: This fully-powered, single-group trial tested whether characteristics of the caregiving context influence high-intensity caregivers' engagement with and benefit from an empirically validated Internet intervention for insomnia. METHODS: At baseline, caregivers providing unpaid time- and responsibility-intensive care who reported insomnia (N = 100; age M = 52.82 [SD = 13.10], 75% non-Hispanic white, 66% ≥college degree) completed questionnaires about caregiving context and sleep, then 10 prospectively-collected online daily sleep diaries. Caregivers then received access to SHUTi (Sleep Healthy Using the Internet), which has no caregiver-specific content, for 9 weeks, followed by post-assessment (questionnaires, diaries). Engagement was tracked by the SHUTi delivery system. RESULTS: Sixty caregivers completed SHUTi, 22 initiated but did not complete SHUTi, and 18 did not initiate SHUTi. Caregivers were more likely to use SHUTi (than not use SHUTi) when their care recipient (CR) had worse functioning, and were more likely to complete SHUTi when supporting more CR activities of daily living (ADL; ps < .03). Higher caregiver guilt, more CR problem behaviors, and being bedpartners with the CR related to more improved sleep outcomes, whereas supporting more CR instrumental ADL related to less improvement (ps < .05). CONCLUSIONS: Factors associated with greater caregiving burden, including greater CR impairment and caregiving guilt, were generally associated with better engagement and outcomes. Caregivers with substantial burdens can adhere to and benefit from a fully automated insomnia program without caregiver-specific tailoring.

This study examined how family caregivers, who often have trouble sleeping due to their responsibilities, used an online insomnia treatment program. The goal was to determine if certain aspects of caregiving would influence how caregivers engage with or benefit from the program. Researchers surveyed 100 caregivers with insomnia about their caregiving situation and sleep, and caregivers also kept online sleep diaries for 10 days. Afterward, caregivers used an online insomnia program with no caregiver-specific content called Sleep Healthy Using the Internet (SHUTi) for 9 weeks. Caregivers' usage was monitored, and they repeated measures of sleep outcomes and 10 online sleep diaries. Sixty caregivers completed SHUTi, 22 partially completed the program, and 18 did not initiate the program. Caregivers who cared for individuals with more severe functional limitations were more likely to use and complete SHUTi. Additionally, caregivers experiencing more guilt and those who managed more challenging behaviors from the person they cared for tended to report greater improvements in their sleep. This study suggests that caregivers, even those with significant care responsibilities, can use and benefit from an online insomnia treatment program like SHUTi, even when it has not been specifically tailored for caregivers.

Caregiver Experiences With an Internet-Delivered Insomnia Intervention: SHUTi-CARE Trial Primary Qualitative Analysis.

BACKGROUND: Digital health interventions show potential to increase caregivers' access to psychosocial care; however, it is unclear to what extent existing interventions may need to be tailored to meet caregivers' unique needs. PURPOSE: This study aimed to determine whether-and if so, how-an efficacious Internet-delivered insomnia program should be modified for caregivers. The generalizability of these findings beyond the tested program was also examined. METHODS: Higher-intensity family caregivers (N = 100; age M = 52.82 [SD = 13.10], 75% non-Hispanic White, 66% ≥college degree) received access to an Internet-based cognitive-behavioral therapy for insomnia (CBT-I) program. Participants who completed one or more intervention "Cores" provided open-ended feedback on their experience; nonusers (completed no Cores) shared their barriers. RESULTS: Most caregivers who used the program (n = 82, 82%) found it feasible, citing its user-friendly, fully automated online format. Many reported that CBT-I strategies were helpful, although some faced challenges in implementing these strategies due to the unpredictability of their caregiving responsibilities. Opinions were divided on the utility of tailoring the program for caregivers. Nonusers (n = 18, 18%) primarily cited concerns about time burden and lifestyle compatibility as usage barriers. CONCLUSIONS: Delivering fully automated behavioral interventions through the Internet appears suitable for many caregivers. Extensive tailoring may not be required for most caregivers to benefit from an existing online CBT-I program, although additional guidance on integrating CBT-I strategies in the context of challenging sleep schedules and environments may help a subset of caregivers. Future research should explore how such tailoring may enhance digital health intervention uptake and effectiveness for caregivers.

This study examined family caregivers' experiences using an online cognitive-behavioral therapy for insomnia program. The aim was to determine if the program needed changes to better fit caregivers' needs. Researchers gave 100 caregivers with insomnia access to Sleep Healthy Using the Internet (SHUTi), an online insomnia program that had no caregiver-specific tailoring. Of the 82 caregivers who used the program, most found the program easy to use and helpful, although some struggled with behavioral strategies because of their unpredictable caregiving duties. There was no clear consensus among caregivers on whether tailoring would be helpful. The 18 caregivers who did not use the program most commonly said that they did not have enough time to use the program or that they felt it would not work well with their lifestyle. Overall, findings suggest that providing interventions via the Internet is a good fit for many caregivers. Many caregivers benefitted from an online insomnia program without being tailored specifically for caregivers, although some additional guidance on how to follow behavioral strategies may be helpful to some caregivers.

Family Cancer Caregiver Use of and Benefit from an Internet-delivered Insomnia Intervention: Results from a Single-Group Feasibility Trial.

Background: Cancer caregivers are more likely to report clinically significant symptoms of insomnia than cancer patients and the general population, yet research has been limited regarding cognitive-behavioral therapy for insomnia (CBT-I) among this population. Methods: To better understand cancer caregivers' engagement with and benefit from CBT-I, cancer caregivers were enrolled in a nonrandomized pilot feasibility trial of an evidence-based Internet-delivered insomnia program. Thirteen caregivers completed mixed-methods assessments prior to receiving the insomnia program and after the nine-week intervention period. Results: Compared to the five caregivers who did not complete any intervention Cores, the eight caregivers who completed at least one of the intervention Cores tended to report more sleep impairment (insomnia symptom severity; minutes of sleep onset latency and wake after sleep onset), less physical and emotional strain from caregiving, and less maladaptive sleep beliefs at the baseline assessment. These caregivers who used the program also showed large improvements in their insomnia symptoms. Caregivers' qualitative feedback about their experience with the program identified potential areas that might be modified to improve caregivers' engagement with and benefit from Internet-delivered insomnia programs. Conclusions: Findings suggest that family cancer caregivers can use and benefit from a fully-automated Internet-delivered CBT-I program, even without caregiving-specific tailoring. Further rigorous research is needed to better understand whether and how program modifications may allow more caregivers to initiate and engage with this program.

Associations between context and affect within the daily lives of cancer caregivers.

PURPOSE: This study used ecological momentary assessment (EMA) to test the association between activity, location, and social company contexts with cancer caregivers' in-the-moment affect to identify precisely when and where to deliver psychological interventions for caregivers. METHODS: Current cancer caregivers (N = 25) received 8 EMA prompts per day for 7 consecutive days. At each prompt, caregivers reported their current positive affect and negative affect, as well as what they were doing, where they were located, and who they were with. Multilevel logistic regressions tested the associations between caregivers' contexts with their own person-mean-centered state (concurrent momentary level) and trait (overall weekly average) positive or negative affect. RESULTS: Caregivers reported lower state negative affect, as well as higher state positive affect, when socializing (ps < .001), when at a public location (ps < .03), and when around their friends, family, spouse/partner, or care recipient (i.e., person with cancer, ps < .02), relative to when not endorsing the context. Caregivers also reported lower state negative affect when eating/drinking or engaging in leisure (ps < .01; but no parallel effects for state positive affect). Caregivers reported higher state negative affect while working, when at their workplace, or when around work colleagues (ps < .001) and lower state positive affect when at home or alone (ps < .03). CONCLUSIONS: Results suggest the pertinence of a behavioral activation framework to mitigate the emotional strain of caregiving. Interventions that facilitate caregivers' ability to socialize with a range of friends and family, including their loved one with cancer, outside of the home may have the strongest positive emotional impact.

Digital health and telehealth in cancer care: a scoping review of reviews.

The COVID-19 pandemic necessitated remote cancer care delivery via the internet and telephone, rapidly accelerating an already growing care delivery model and associated research. This scoping review of reviews characterised the peer-reviewed literature reviews on digital health and telehealth interventions in cancer published from database inception up to May 1, 2022, from PubMed, Cumulated Index to Nursing and Allied Health Literature, PsycINFO, Cochrane Reviews, and Web of Science. Eligible reviews conducted a systematic literature search. Data were extracted in duplicate via a pre-defined online survey. Following screening, 134 reviews met the eligibility criteria. 77 of those reviews were published since 2020. 128 reviews summarised interventions intended for patients, 18 addressed family caregivers, and five addressed health-care providers. 56 reviews did not target a specific phase of the cancer continuum, whereas 48 reviews tended to address the active treatment phase. 29 reviews included a meta-analysis, with results showing positive effects on quality of life, psychological outcomes, and screening behaviours. 83 reviews did not report intervention implementation outcomes but when reported, 36 reported acceptability, 32 feasibility, and 29 fidelity outcomes. Several notable gaps were identified in these literature reviews on digital health and telehealth in cancer care. No reviews specifically addressed older adults, bereavement, or sustainability of interventions and only two reviews focused on comparing telehealth to in-person interventions. Addressing these gaps with rigorous systematic reviews might help guide continued innovation in remote cancer care, particularly for older adults and bereaved families, and integrate and sustain these interventions within oncology.

Effects of an internet-delivered insomnia intervention for older adults: A secondary analysis on symptoms of depression and anxiety.

OBJECTIVE: To test whether an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) program for older adults attenuates symptoms of depression and anxiety. METHODS: Adults aged ≥ 55 with insomnia were randomized to SHUTi-OASIS (Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness; N = 207) or Patient Education (PE; N = 104). Depression and anxiety were assessed (HADS-D and HADS-A, respectively) at baseline, post-assessment, and 6- and 12-month follow-ups. RESULTS: Multilevel modeling of HADS-D showed a condition by time interaction (F[3,779] = 3.23, p = .02): SHUTi-OASIS participants reported lower symptoms than PE at post-assessment. There was no such interaction effect for HADS-A (F[3,779] = 2.12, p = .10). Generalized linear modeling showed no moderation of effects by baseline symptom severity. CONCLUSIONS: Participants randomized to Internet-delivered CBT-I showed stable depression and anxiety across time, while control participants' depressive symptoms briefly increased. CBT-I may help prevent development or worsening of psychological distress among older adults with insomnia. TRIAL REGISTRATION: [Registered at ClinicalTrials.gov; identifier removed for anonymity].

Including partners in discussions of sexual side effects from breast cancer: a qualitative study of survivors, partners, and providers.

PURPOSE: Ensuring there are clear standards for addressing cancer-related sexual side effects is important. Currently, there are differences in two leading sets of clinical guidelines regarding the inclusion of survivors' romantic partners into clinical discussions between survivors and their providers about this issue. To help refine guidelines, we examine breast cancer survivor, partner, and oncology provider perspectives about including partners in discussions about cancer-related sexual side effects in a secondary analysis of a broader qualitative study. METHODS: Partnered female breast cancer survivors (N = 29) completed online surveys, and intimate partners of breast cancer survivors (N = 12) and breast oncology providers (N = 8) completed semi-structured interviews. Themes were derived from thematic content analysis. RESULTS: Among survivors who reported a discussion with their provider, fewer than half indicated their partner had been present, despite most survivors expressing it was - or would have been - helpful to include their partner. Partners also largely indicated being included was or would have been helpful, when welcomed by the survivor. Providers similarly emphasized the importance of survivors' autonomy in deciding whether to discuss sexual concerns in the presence of a partner. CONCLUSIONS: Partners were infrequently included in conversations about cancer-related sexual side effects, even though survivors, partners, and providers alike expressed value in these discussions occurring with the couple together - when that is the survivor's preference. Findings suggest future clinical guidelines should emphasize that incorporating partners into clinical discussions about sexual concerns is important for many breast cancer patients. Soliciting and enacting patients' preferences is essential for truly patient-centered care.

Single-Group Trial of an Internet-Delivered Insomnia Intervention Among Higher-Intensity Family Caregivers: Rationale and Protocol for a Mixed Methods Study.

BACKGROUND: Family caregivers are more likely to experience insomnia relative to noncaregivers but have significant barriers to accessing gold standard cognitive behavioral therapy for insomnia treatment. Delivering interventions to caregivers through the internet may help increase access to care, particularly among higher-intensity caregivers who provide assistance with multiple care tasks over many hours per week. Although there are existing internet interventions that have been thoroughly studied and demonstrated as effective in the general population, the extent to which these interventions may be effective for caregivers without tailoring to address this population's unique psychosocial needs has not been studied. OBJECTIVE: The goal of this trial is to determine what tailoring may be necessary for which caregivers to ensure they receive optimal benefit from an existing evidence-based, internet-delivered cognitive behavioral therapy for insomnia program named Sleep Healthy Using the Internet (SHUTi). Specifically, we will test the association between caregivers' engagement with SHUTi and their caregiving context characteristics (ie, caregiving strain, self-efficacy, and guilt) and environment (ie, proximity to care recipient; functional status, cognitive status, and problem behavior of care recipient; and type of care provided). Among caregivers using the program, we will also test the associations between change in known treatment mechanisms (sleep beliefs and sleep locus of control) and caregiving context factors. METHODS: A total of 100 higher-intensity caregivers with significant insomnia symptoms will be recruited from across the United States to receive access to SHUTi in an open-label trial with mixed methods preassessments and postassessments. At postassessment (9 weeks following preassessment completion), participants will be categorized according to their engagement with the program (nonusers, incomplete users, or complete users). Study analyses will address 3 specific aims: to examine the association between caregivers' engagement with SHUTi and their caregiving context (aim 1a); to describe caregivers' barriers to and motivations for SHUTi engagement from open-ended survey responses (aim 1b); and among caregivers using SHUTi, to determine whether cognitive mechanisms of change targeted by SHUTi are associated with differences in caregiving context (aim 2). RESULTS: Institutional review board approvals have been received. Data collection is anticipated to begin in December 2021 and is expected to be completed in 2023. CONCLUSIONS: Findings will inform the next research steps for tailoring and testing SHUTi for optimal impact and reach among caregivers. Beyond implication to the SHUTi program, the findings will be translatable across intervention programs and will hold significant promise to reduce inefficiencies in developing digital health interventions for caregivers while also increasing their impact and reach for this underserved population. TRIAL REGISTRATION: ClinicalTrials.gov; NCT04986904; https://clinicaltrials.gov/ct2/show/NCT04986904?term=NCT04986904. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/34792.

Addressing sexual concerns of female breast cancer survivors and partners: a qualitative study of survivors, partners, and oncology providers about Internet intervention preferences.

PURPOSE: Sexual side effects after breast cancer treatment are common and distressing to both survivors and their intimate partners, yet few receive interventions to address cancer-related sexual concerns. To direct intervention development, this qualitative study assessed the perceptions of female breast cancer survivors, intimate partners of breast cancer survivors, and breast cancer oncology providers about how an Internet intervention for couples may address breast cancer-related sexual concerns. METHODS: Survivors (N = 20) responded to online open-ended surveys. Partners (N = 12) and providers (N = 8) completed individual semi-structured interviews. Data were inductively coded using thematic content analysis. RESULTS: Three primary intervention content areas were identified by the key stakeholder groups: (1) information about and strategies to manage physical and psychological effects of cancer treatment on sexual health, (2) relationship and communication support, and (3) addressing bodily changes and self-image after treatment. Survivors and partners tended to express interest in some individualized intervention private from their partner, although they also emphasized the importance of opening communication about sexual concerns within the couple. Survivors and partners expressed interest in an intervention that addresses changing needs across the cancer trajectory, available from the time of diagnosis and through survivorship. CONCLUSION: Internet intervention for couples to address cancer-related sexual concerns, particularly one that provides basic education about treatment side effects and that evolves with couples' changing needs across the cancer trajectory, was perceived as a valuable addition to breast cancer care by survivors, partners, and providers.

Liar! Liar! Identifying eligibility fraud by applicants in digital health research.

Online studies enable researchers to recruit large, diverse samples, but the nature of these studies provides an opportunity for applicants to misrepresent themselves to increase the likelihood of meeting eligibility criteria for a trial, particularly those that provide financial incentives. This study describes rates of fraudulent applications to an online intervention trial of an Internet intervention for insomnia among older adults (ages ≥55). Applicants were recruited using traditional (e.g., flyers, health providers), online (e.g., Craigslist, Internet searches), and social media (e.g., Facebook) recruitment methods. Applicants first submitted an interest form that included identifying information (name, date of birth, address). This data was then queried against a national database (TransUnion's TLOxp) to determine the application's verification status. Applications were determined to be verified (i.e., information from interest form matched TLOxp report), potentially fraudulent (i.e., potential discrepancy in provided information on interest form versus TLOxp report), or fraudulent (i.e., confirmed discrepancy). Of 1766 total interest forms received, 125 (7.08%) were determined to be fraudulent. Enrollment attempts that were fraudulent were detected among 12.22% of applicants who reported learning of the study through online, 7.04% through social media, 4.58% through traditional, and 4.27% through other methods. Researchers conducting online trials should take precautions, as applicants may provide fraudulent information to gain access to their studies. Reviewing all applications and verifying the identities and eligibility of participants is critical to the integrity of online research trials.

Feasibility of ecological momentary assessment to study depressive symptoms among cancer caregivers.

OBJECTIVE: Ecological momentary assessment (EMA) may help with the development of more targeted interventions for caregivers' depression, yet the use of this method has been limited among cancer caregivers. This study aimed to demonstrate the feasibility of EMA among cancer caregivers and the use of EMA data to understand affective correlates of caregiver depressive symptoms. METHODS: Caregivers (N = 25) completed a depressive symptom assessment (Patient Health Questionnaire-8) and then received eight EMA survey prompts per day for 7 days. EMA surveys assessed affect on the orthogonal dimensions of valence and arousal. Participants completed feedback surveys regarding the EMA protocol at the conclusion of the week-long study. RESULTS: Of 32 caregivers approached, 25 enrolled and participated (78%), which exceeded the a priori feasibility cutoff of 55%. The prompt completion rate (59%, or 762 of 1,286 issued) did not exceed the a priori cutoff of 65%, although completion was not related to caregivers' age, employment status, physical health quality of life, caregiving stress, or depressive symptoms or the patients' care needs (ps > 0.22). Caregivers' feedback about their study experience was generally positive. Mixed-effects location scale modeling showed caregivers' higher depressive symptoms were related to overall higher reported negative affect and lower positive affect, but not to affective variability. CONCLUSIONS: Findings from this feasibility study refute potential concerns that an EMA design is too burdensome for distressed caregivers. Clinically, findings suggest the potential importance of not only strategies to reduce overall levels of negative affect, but also to increase opportunities for positive affect.