A Randomized Pilot Trial of the Donor Conception Tool to Empower Parental Telling and Talking (TELL Tool) with Their Children About Their Genetic Origins.

INTRODUCTION: Parents who use donated gametes or embryos to form their families struggle with telling their children about their genetic origins. We developed the Tool to Empower Parental Telling and Talking (TELL Tool) to support parents in disclosure to their children and an eBook attention control. METHOD: A randomized parallel, two-group, attention-controlled clinical pilot trial was conducted online during COVID-19. Feasibility, acceptability, and preliminary effects among parents with children aged 1-16 years were examined. RESULTS: Over 10 months, our target of 75 parents were enrolled (85% of eligible [95% confidence interval (CI), 76% to 91%]), and 68% (95% CI: 57% to 78%) were retained at 12 weeks. At 4 and 12 weeks, positive trends were found for parental disclosure, telling confidence, and anxiety compared with attention controls. DISCUSSION: The study protocol is feasible, and the TELL Tool is acceptable to parents and demonstrates a positive effect on parents' ability to tell their children. The results support the implementation of a large efficacy trial.

Act or Wait? Presentation Delay in Symptomatic Breast Cancer in China.

BACKGROUND: In Western countries, factors contributing to breast cancer presentation delay have been identified, but little is known about presentation delay in China, where culture and healthcare systems are quite different. OBJECTIVE: To describe the delay interval among newly diagnosed breast cancer patients in China and to identify factors influencing delay, including the COVID-19 pandemic. METHODS: Using a cross-sectional design, we recruited 154 participants within 3 months of pathological diagnosis of breast cancer. Data were collected using standardized scales and open-ended questions. RESULTS: We found 44.8% of participants delayed ≥1 month, and 24.7% delayed ≥3 months before presentation, after self-discovery of symptoms. Logistic regression analysis showed that factors associated with longer delay (≥1 month) included preferring female physicians for breast examination, fewer negative emotions (afraid, anxious, distressed) regarding breast symptoms, more competing priorities, believing folk therapy can help treat lumps, and visiting a secondary or tertiary hospital instead of primary healthcare providers (P < .05 for all). Interaction tests showed perceived seriousness of symptoms significantly predicted delay of ≥1 month only when perceived healthcare access or trust in physicians was low. Patients (14%) reported delaying due to fear of COVID-19 infection and inability to leave home. CONCLUSIONS: Presentation delays were substantial and multilevel barriers to timely presentation were identified, which would be expected to contribute to later-stage cancer at diagnosis. IMPLICATIONS FOR PRACTICE: Findings suggest that nursing interventions and improved health policies are urgently needed in China, including breast cancer education to increase awareness.

Role of Pain Catastrophizing in the Effects of Cognitive Behavioral Therapy for Chronic Pain in Different Subgroups: An Exploratory Secondary Data Analysis Using Finite Mixture Models.

INTRODUCTION: Providing effective treatment for debilitating chronic pain is a challenge among many populations including military service members. Cognitive behavioral therapy for chronic pain (CBT-CP) is a leading psychological pain treatment. Pain catastrophizing is a pivotal mediator of pain-related outcomes. The purpose of this study was (1) to identify patient subgroups who differ in response to CBT-CP and (2) to explore the characteristics that define these patient subgroups. The overall goal was to obtain a better understanding of factors that may influence response to CBT-CP. MATERIALS AND METHODS: This study was a secondary analysis of data from a clinical trial of 149 U.S. active duty service members with chronic pain. Participants underwent group-based CBT-CP for 6 weeks and completed pre- and posttreatment assessments. Finite mixture models were employed to identify subgroups in treatment response, with pain impact score as the primary outcome measure. RESULTS: We identified two classes of nearly equal size with distinct pain impact responses. One class reported improved pain impact scores following CBT-CP. This improvement was significantly associated with lower (better) baseline depression scores and greater improvement in posttreatment pain catastrophizing. In contrast, the other class reported slightly worse mean pain impact scores following CBT-CP treatment; this response was not related to baseline depression or change in pain catastrophizing. CONCLUSIONS: Our findings demonstrate that a sizable proportion of individuals with chronic pain may not respond to group-based CBT-CP and may require a more individualized treatment approach.

Lack of Diversity in Research on Females with Ehlers-Danlos Syndromes: Recruitment Protocol for a Quantitative Online Survey.

BACKGROUND: Ehlers-Danlos syndromes (EDS) are a group of connective tissue disorders caused by fragile lax collagen. Current EDS research lacks racial and ethnic diversity. The lack of diversity may be associated with the complexities of conducting a large international study on an underdiagnosed condition and a lack of EDS health care providers who diagnose and conduct research outside of the United States and Europe. Social media may be the key to recruiting a large diverse EDS sample. However, studies that have used social media to recruit have not been able to recruit diverse samples. OBJECTIVE: This study aims to discuss challenges, strategies, outcomes, and lessons learned from using social media to recruit a large sample of females with EDS. METHODS: Recruitment on social media for a cross-sectional survey examining dyspareunia (painful sexual intercourse) in females was examined. Inclusion criteria were (1) older than 18 years of age, (2) assigned female at birth, and (3) diagnosed with EDS. Recruitment took place on Facebook and Twitter (now X), from June 1 to June 25, 2019. RESULTS: A total of 1178 females with EDS were recruited from Facebook (n=1174) and X (n=4). On Facebook, participants were recruited via support groups. A total of 166 EDS support groups were identified, 104 permitted the principal investigator to join, 90 approved posting, and the survey was posted in 54 groups. Among them, 30 of the support groups posted in were globally focused and not tied to any specific country or region, 21 were for people in the United States, and 3 were for people outside of the United States. Recruitment materials were posted on X with the hashtag #EDS. A total of 1599 people accessed the survey and 1178 people were eligible and consented. The average age of participants was 38.6 (SD 11.7) years. Participants were predominantly White (n=1063, 93%) and non-Hispanic (n=1046, 92%). Participants were recruited from 29 countries, with 900 (79%) from the United States and 124 (11%) from Great Britain. CONCLUSIONS: Our recruitment method was successful at recruiting a large sample. The sample was predominantly White and from North America and Europe. More research needs to be conducted on how to recruit a diverse sample. Areas to investigate may include connecting with more support groups from outside the United States and Europe, researching which platforms are popular in different countries, and translating study materials into different languages. A larger obstacle to recruiting diverse samples may be the lack of health care providers that diagnose EDS outside the United States and Europe, making the pool of potential participants small. There needs to be more health care providers that diagnose and treat EDS in countries that are predominantly made up of people of color as well as research that specifically focuses on these populations. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/53646.

Exploring Preventive Health Care Utilization Among Black/African American Men.

Black/African American (BAA) men have the lowest life expectancy among other major demographic groups in the United States, with BAA male mortality rates 40% higher than their White male counterparts. Despite known benefits of preventive health care utilization, BAA men are 43% more likely to use the emergency department for usual care. Many intersecting factors like medical mistrust and religion have been identified as common barriers BAA men face in health care utilization with few studies exploring factors that impact their current preventive health care utilization. In addition, BAA men's perceptions of health and ability to identify or seek help have always been disproportionately lower than other racial groups despite higher rates of preventable diseases. Using the tenets of the Andersen Healthcare Utilization Model, this cross-sectional study of 176 BAA men explores BAA men's current preventive health care practices while examining the intersection of predisposing, enabling, and need factors on BAA men's preventive health care utilization. While it is well known that higher income levels and higher education positively influence health care utilization, the intersection of religious affiliation and higher levels of medical mistrust was associated with BAA men's decreased engagement with health care as religion posed as a buffer to health care utilization. This study demonstrated that BAA men's perception of health differed by sexual orientation, educational status, and income. However, across all groups the participants' perspective of their health was not in alignment with their current health outcomes. Future studies should evaluate the impact of masculine norms as potential enabling factors on BAA men's preventive health care utilization.

Pain Catastrophizing and Its Association with Military Medical Disability Among US Active Duty Service Members with Chronic Predominately Musculoskeletal Pain: A Retrospective Cohort Analysis.

Context: Pain catastrophizing is characterized by negative emotional and cognitive responses to pain and is a predictor of work-related disability. Its association with military medical disability has not been studied. Objective: To (1) identify the pain catastrophizing scale (PCS) score cut point most strongly associated with military medical disability, (2) measure the difference in rate of disability between service members with baseline PCS scores above versus below the cut point, and (3) determine if improvement in PCS score during pain specialty care is associated with decreased likelihood of disability. Methods: This was a retrospective cohort analysis comparing PCS scores collected from US Army active duty service members at time of initial visit to an interdisciplinary pain management center and periodically during pain treatment. Outcome was determination during the following year of a military service-disqualifying disability. Results: Receiver operating characteristic (ROC) curves determined that a PCS score of 20 was the single cut point most closely associated with subsequent disability. Kaplan-Meier curves showed significantly higher disability rate during the following year among those with baseline PCS scores ≥20 (52%) compared to those with lower scores (26%). Scheffe-adjusted contrasts showed that service members with PCS scores ≥20 whose scores improved to <20 at follow-up were significantly less likely to have a medical disability (42.6%; 95% CI, 0.07-0.58) than those whose PCS score remained ≥20 (76.3%; 95% CI, 68.0%-84.7%). Conclusion: A PCS score cut point of 20 distinguishes between high versus low likelihood of disability among service members. Those with high baseline PCS score had twice the likelihood of disability than those with low scores. Service members who decreased their PCS score from high to low during pain specialty care had lower likelihood of disability. Prospective research is needed to determine if treatments that lower pain catastrophizing yield reduced likelihood of subsequent disability.

Predictors of Sustained Response to Functional Restoration in a Military Population.

INTRODUCTION: The purpose of this study was to determine if improvement in pain impact and functional performance following a functional restoration (FR) program was sustained up to 6 months posttreatment and to identify predictors of sustained improvement. MATERIALS AND METHODS: Secondary analysis of data collected during randomized clinical trial. Study population included 108 US active duty service members who completed an FR program, as well as 3- and/or 6-month follow-up assessments. Primary outcome measure was the NIH Research Task Force (pain) impact score (PIS). Secondary outcome was a composite functional performance measure of treadmill, lifting, and carrying tolerances. Variables analyzed to determine their predictive value included demographics; treatment hours; measures of pain intensity, function, mood, sleep, social satisfaction, pain catastrophizing, kinesiophobia, self-efficacy, pain acceptance, patient activation, functional performance, and neuropathic pain. RESULTS: Mean PIS and functional performance improved significantly immediately following FR, but after 6 months, only improvement in functional performance sustained. Responder analysis showed that 6 months after FR, 42% of participants reported improvement that exceeded the minimal clinically important difference in PIS or functional performance. Predictors of sustained PIS improvement included younger age, absence of neuropathic pain features, less self-rated disability, better baseline functional performance, and worse baseline PIS. Predictors of sustained functional performance improvement included more treatment hours, lower baseline pain catastrophizing, and lower baseline functional performance. CONCLUSIONS: This study supports the investment of treatment time in FR to yield sustained clinically meaningful improvement, as observed in over 40% of this study's military participants. Pretreatment predictors of sustained response included lower pain catastrophizing and absence of neuropathic pain. Further research is needed to determine if treatments that improve pain catastrophizing and neuropathic pain will result in sustained improvement in pain impact and functional performance following FR program participation.

Monitoring and responding to signals of suicidal ideation in pragmatic clinical trials: Lessons from the GRACE trial for Chronic Sickle Cell Disease Pain.

Sickle cell disease (SCD) is a hemoglobin disorder and the most common genetic disorder that affects 100,000 Americans and millions worldwide. Adults living with SCD have pain so severe that it often requires opioids to keep it in control. Depression is a major global public health concern associated with an increased risk in chronic medical disorders, including in adults living with sickle cell disease (SCD). A strong relationship exists between suicidal ideation, suicide attempts, and depression. Researchers enrolling adults living with SCD in pragmatic clinical trials are obligated to design their methods to deliberately monitor and respond to symptoms related to depression and suicidal ideation. This will offer increased protection for their participants and help clinical investigators meet their fiduciary duties. This article presents a review of this sociotechnical milieu that highlights, analyzes, and offers recommendations to address ethical considerations in the development of protocols, procedures, and monitoring activities related to suicidality in depressed patients in a pragmatic clinical trial.

Association between sleep variability and time in range of glucose levels in patients with type 1 diabetes: Cross-sectional study.

OBJECTIVE: Sleep and circadian disturbances emerge as novel factors influencing glycemic control in type 1 diabetes (T1D). We aimed to explore the associations among sleep, behavioral circadian parameters, self-care, and glycemic parameters in T1D. METHODS: Seventy-six non-shift-working adult T1D patients participated. Blinded 7-day continuous glucose monitoring (CGM) and hemoglobin A1C (A1C) were collected. Percentages of time-in-range (glucose levels 70-180 mg/dL) and glycemic variability (measured by the coefficient of variation [%CV]) were calculated from CGM. Sleep (duration and efficiency) was recorded using 7-day actigraphy. Variability (standard deviation) of midsleep time was used to represent sleep variability. Nonparametric behavioral circadian variables were derived from actigraphy activity recordings. Self-care was measured by diabetes self-management questionnaire-revised. Multiple regression analyses were performed to identify independent predictors of glycemic parameters. RESULTS: Median (interquartile range) age was 34.0 (27.2, 43.1) years, 48 (63.2%) were female, and median (interquartile range) A1C was 6.8% (6.2, 7.4). Sleep duration, efficiency, and nonparametric behavioral circadian variables were not associated with glycemic parameters. After adjusting for age, sex, insulin delivery mode/CGM use, and ethnicity, each hour increase in sleep variability was associated with 9.64% less time-in-range (B = -9.64, 95% confidence interval [-16.29, -2.99], p ≤ .001). A higher diabetes self-management questionnaire score was an independent predictor of lower A1C (B = -0.18, 95% confidence interval [-0.32, -0.04]). CONCLUSION: Greater sleep timing variability is independently associated with less time spent in the desirable glucose range in this T1D cohort. Reducing sleep timing variability could potentially lead to improved metabolic control and should be explored in future research. DATA AVAILABILITY STATEMENT: Data are available upon a reasonable request to the corresponding author.

Distinct Dysphagia Profiles in Patients With Oral Cancer After Surgery.

OBJECTIVES: To determine distinct profiles based on symptom severity in patients undergoing surgery for oral cancer and examine whether these profiles differ by participant characteristics. SAMPLE & SETTING: 300 patients who underwent surgery for oral cancer at two outpatient clinics between June and December 2021. METHODS & VARIABLES: Symptoms were assessed using the MD Anderson Symptom Inventory-Head and Neck Cancer Module. Sociodemographic and clinical characteristics were collected. Latent profile analysis was performed. RESULTS: Five distinct dysphagia profiles were identified, which qualitatively differed regarding co-occurrence patterns of dysphagia, mucus-related symptoms, speech disturbances, and psychoneurologic symptoms. Significant differences were reported in interference to function, number of co-occurring symptoms, time since diagnosis and treatment completion, use of symptom management medications, oral cancer stage and site, and treatment completed. IMPLICATIONS FOR NURSING: Identifying distinct dysphagia profiles can improve patient outcomes and help in planning specific nursing interventions to influence nutritional and functional status in oral cancer survivors. Dysphagia and dry mouth can persist beyond one year post-treatment, so follow-up dysphagia assessments are needed.

Correction: OjiNjideka Hemphill et al. Feasibility Study of Lactobacillus Plantarum 299v Probiotic Supplementation in an Urban Academic Facility among Diverse Pregnant Individuals. Nutrients 2023, 15, 875.

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Impart: findings from a prison-based model of HIV assisted partner notification in Indonesia.

INTRODUCTION: Assisted partner notification (APN) safely and effectively increases partner awareness of HIV exposure, testing and case identification in community settings. Nonetheless, it has not been specifically developed or evaluated for use in prison settings where people with HIV often are diagnosed and may have difficulty contacting or otherwise notifying partners. We developed Impart, a prison-based APN model, and evaluated its efficacy in Indonesia to increase partner notification and HIV testing. METHODS: From January 2020 to January 2021, 55 incarcerated men with HIV were recruited as index participants from six jail and prison facilities in Jakarta in a two-group randomized trial comparing the outcomes of self-tell notification (treatment as usual) versus Impart APN in increasing partner notification and HIV testing. Participants voluntarily provided names and contact information for sex and drug-injection partners in the community with whom they had shared possible HIV exposure during the year prior to incarceration. Participants randomized to the self-tell only condition were coached in how to notify their partners by phone, mail or during an in-person visit within 6 weeks. Participants randomized to Impart APN could choose between self-tell notification or anonymous APN by a two-person team consisting of a nurse and outreach worker. We compared the proportion of partners in each group who were notified of exposure by the end of 6 weeks, subsequently tested and HIV diagnosed. RESULTS: Index participants (n = 55) selected 117 partners for notification. Compared to self-tell notification, Impart APN resulted in nearly a six-fold increase in the odds of a named partner being notified of HIV exposure. Nearly two thirds of the partners notified through Impart APN (15/24) completed HIV testing within 6 weeks post notification compared to none of those whom participants had self-notified. One-third of the partners (5/15) who completed HIV testing post notification were diagnosed as HIV positive for the first time. CONCLUSIONS: Voluntary APN can be successfully implemented with a prison population and within a prison setting despite the many barriers to HIV notification that incarceration presents. Our findings suggest that the Impart model holds considerable promise to increase partner notification, HIV testing and diagnosis among sex and drug-injecting partners of HIV-positive incarcerated men.

Symptom Cluster Experiences of Patients Operated for Oral Cancer: A Mixed Methods Study.

OBJECTIVE: This convergent mixed methods study aimed to obtain a comprehensive understanding of symptom cluster experiences in patients with oral cancer. Survey and phenomenological interviews were conducted in parallel to identify distinct patient subgroups based on symptom cluster experiences along with their predictors and explore experiences of living with symptom clusters, respectively. DATA SOURCES: A convenience sample of 300 patients with oral cancer who had completed surgery provided the quantitative data, and a maximum variation purposive subsample of 20 participants, drawn from the survey sample, provided the qualitative data. Agglomerative hierarchical cluster analysis was used to identify subgroups, multivariate analyses were done to identify predictors, and thematic analysis was used for patient narratives. CONCLUSION: Almost 94% of the survey participants had two or more co-occurring symptoms. The four most severe and prevalent symptoms were dysphagia, problems with teeth or gums, speech difficulty, and dry mouth. A distinct subgroup consisting of 61% of patients reported severe dysphagia and teeth problems, which was associated with age, oral cancer stage and site. Interviews revealed the causes and the context influencing the perception and response to these symptoms. Thus, the quantitative data provided information on severity and patient subgroups based on symptom cluster experiences, while the qualitative data validated these conclusions and additionally provided in-depth details and meaningful insight on perceived causes and contextual influences of their experiences. This comprehensive picture of symptom cluster experiences can aid in the development of patient-centered interventions for people with oral cancer. IMPLICATIONS FOR NURSING PRACTICE: An interdisciplinary approach to targeting concurrent symptoms incorporating psychological and physical interventions is necessary. Older patients treated for Stage IV cancers and for buccal mucosa tumors are at high-risk of having severe dysphagia postoperatively, and these patients should be targeted for dysphagia interventions. The contextual factors play an important role in developing patient-centered interventions.

Associations in Cigarette Smoking and Health Conditions by Race/Ethnicity Among a Diverse Sample of Patients Receiving Treatment in a Federally Qualified Health Care Setting in Chicago.

Purpose: To examine the association of cigarette use and smoking-related health conditions by race/ethnicity among diverse and low-income patients at a federally qualified health center (FQHC). Methods: Demographics, smoking status, health conditions, death, and health service use were extracted from electronic medical data for patients seen between September 1, 2018, and August 31, 2020 (n=51,670). Smoking categories included everyday/heavy smoker, someday/light smoker, former smoker, or never smoker. Results: Current and former smoking rates were 20.1% and 15.2%, respectively. Males, Black, White, non-partnered, older, and Medicaid/Medicare patients were more likely to smoke. Compared with never smokers, former and heavy smokers had higher odds for all health conditions except respiratory failure, and light smokers had higher odds of asthma, chronic obstructive pulmonary disease, emphysema, and peripheral vascular disease. All smoking categories had more emergency department visits and hospitalizations than never smokers. The associations between smoking status and health conditions differed by race/ethnicity. White patients who smoked had a greater increase in odds of stroke and other cardiovascular diseases compared with Hispanic and Black patients. Black patients who smoked had a greater increase in odds of emphysema and respiratory failure compared with Hispanic patients. Black and Hispanic patients who smoked had a greater increase in emergency care use compared with White patients. Conclusion: Smoking was associated with disease burden and emergency care and differed by race/ethnicity. Health Equity Implications: Resources to document smoking status and offer cessation services should be increased in FQHCs to promote health equity for lower income populations.

Feasibility Study of Lactobacillus Plantarum 299v Probiotic Supplementation in an Urban Academic Facility among Diverse Pregnant Individuals.

(1) Background: Despite iron intake recommendations, over a quarter of pregnant individuals have iron deficiency. Lactobacillus plantarum 299v (Lp299v®) enhances iron absorption in non-pregnant populations and may have positive effects in pregnancy among those with sufficient iron stores; however, no studies have evaluated the effect of Lp299v® on maternal and neonatal iron status among individuals at risk for iron deficiency anemia in pregnancy. Thus, this study aims to assess the feasibility and preliminary efficacy of daily oral Lp299v® maternal supplementation among diverse pregnant individuals. (2) Methods: In this double-blind placebo-controlled randomized supplementation feasibility study, participants were randomized to probiotic Lp299v® + prenatal vitamin with iron or placebo + prenatal vitamin with iron from 15-20 weeks of gestation through delivery. (3) Results: Of the 20 enrolled and randomized participants, 58% (7/12) from the Lp299v® group and 75% (6/8) from the placebo group were retained. Adherence to supplementation was 72% for Lp299v®/placebo and 73% for the prenatal vitamin. A slower decline in maternal hematological and iron parameters across pregnancy was observed in the Lp299v® group compared to placebo. (4) Conclusions: Lp299v® may be a tolerable therapy during pregnancy and has the potential to affect maternal and neonatal hematological and iron status.

Hybrid effectiveness-implementation trial of guided relaxation and acupuncture for chronic sickle cell disease pain (GRACE): A protocol.

Background: People with sickle cell disease frequently use complementary and integrative therapies to cope with their pain, yet few studies have evaluated their effectiveness. The 3-arm, 3-site pragmatic Hybrid Effectiveness-implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (GRACE) has 3 priorities: (1) evaluate guided relaxation and acupuncture to improve pain control; (2) determine the most appropriate and effective treatment sequence for any given patient based on their unique characteristics; and (3) describe the processes and structures required to implement guided relaxation and acupuncture within health care systems. Methods: Participants (N = 366) are being recruited and randomized 1:1:1 to one of 2 intervention groups or usual care. The acupuncture intervention group receives 10 sessions over approximately 5 weeks. The guided relaxation intervention group receives access to video sessions ranging from 2 to 20 min each viewed daily over 5 weeks. The usual care group receives the standard of clinical care for sickle cell disease. Participants are re-randomized at 6 weeks depending on their pain impact score. Assessments occur at 6 weeks, 12 weeks, and 24 weeks. The primary outcome is the change in pain impact score and secondary measures include opioid use, anxiety, depression, sleep, pain catastrophizing, substance use, global impression of change, constipation, and hospitalizations. The GRACE study uses the Consolidated Framework for Implementation Research to plan, execute, and evaluate the associated implementation processes. Conclusion: The results from GRACE will represent a critical step toward improving management of pain affecting patients with sickle cell disease.ClinicalTrials.gov Identifier: NCT04906447.

The Role of Psychological Factors in Chronic Pain Treatment Outcomes in the Military.

PURPOSE: Chronic pain treatment in the military includes complementary and integrative health (CIH) therapies that may affect psychological factors such as pain catastrophizing, chronic pain acceptance, pain self-efficacy, and patient activation. The unique roles that psychosocial factors play in how CIH approaches reduce pain are not clear. This study examined if a holistic pain management program improved pain outcomes through psychological mediators in service members with chronic pain. DESIGN: Secondary analysis of a clinical trial. METHODS: Active-duty service members (n = 210) were randomly assigned to a 3-week course of standard rehabilitative care or standard rehabilitative care combined with CIH therapies. Both treatments were followed by a 3-week functional restoration program. Study measures were completed pre- and post-treatment using the Military Health System's Pain Assessment Screening Tool and Outcomes Registry. Mediation analyses tested the indirect effects of the change in psychological factors before functional restoration on the change in pain impact (e.g., pain intensity, pain interference, functional status) after functional restoration. RESULTS: All psychological factors except for chronic pain acceptance were related to improved pain impact (p<.05). Furthermore, a change in psychological factors prior to functional restoration was related to the change in pain impact after functional restoration. However, the addition of CIH therapies to standard rehabilitative care did not result in changes in pain outcomes mediated by the psychological factors. CONCLUSIONS: Although psychological factors were related to pain outcomes, the effect of CIH therapies on chronic pain did not occur via a change in the four psychological factors.

On a pathway to resigned acceptance: Patients' experiences of living with symptom clusters in oral cancer.

PURPOSE: Patients treated for oral cancer experience multiple concurrent symptoms. A larger mixed-methods study was conducted among patients who were treated with surgery alone or in combination with other modalities. The aim of the qualitative strand was to explore the experiences of living with symptom clusters. METHODS: A phenomenological design was used to explore the lived experiences. Participants were recruited for the larger study from two outpatient units of a tertiary teaching hospital (N = 300). After completion of a survey, a maximum variation purposive subsample of 20 participants was drawn from the larger sample and were interviewed in-depth about their experiences. Thematic analysis was conducted. FINDINGS: All participants experienced multiple concurrent symptoms, commonly including chewing difficulties + dry mouth + speech difficulties; chewing difficulties + dry mouth + diminished taste; and chewing difficulties + dry mouth + speech difficulties + trismus. Analysis of their experiences of living with these symptom clusters revealed six themes: Acknowledged Disruptions, Inner Dialogue, Shifting Expectations, Floods of Emotions, Exercising Control over Life, and Resigned Acceptance. These themes portrayed that time and living with symptom clusters lead to what we describe as a pathway to resigned acceptance. This pathway is intermingled with disruptions, self-reflections on 'why me' and karma, negative emotions, and failed expectations regarding symptom recovery. Attempts to exercise control over their lives were also revealed through coping strategies, watchful living, future planning, and being health advocates. On realizing with time that further symptom alleviation is unlikely, and considering symptom-cluster experiences as being written in their fate, they move towards a state of resigned acceptance. However, unlike passive acceptance, their belief in fate was accompanied with resilience, evidenced by their ongoing efforts to explore pragmatic ways to live with symptom clusters. CONCLUSIONS: Findings provide key insights into patient perspectives which most often remain unexpressed in clinical settings. Further research is required to explore watchful living, fate as a coping strategy, and intertwining of faith, fate, and karma.

Sleep-Opt-In: A Randomized Controlled Pilot Study to Improve Sleep and Glycemic Variability in Adults With Type 1 Diabetes.

PURPOSE: The purpose of this study was to evaluate the feasibility and acceptability of a technology-assisted behavioral sleep intervention (Sleep-Opt-In) and to examine the effects of Sleep-Opt-In on sleep duration and regularity, glucose indices, and patient-reported outcomes. Short sleep duration and irregular sleep schedules are associated with reduced glycemic control and greater glycemic variability. METHODS: A randomized controlled parallel-arm pilot study was employed. Adults with type 1 diabetes (n = 14) were recruited from the Midwest and randomized 3:2 to the sleep-optimization (Sleep-Opt-In) or Healthy Living attention control group. Sleep-Opt-In was an 8-week, remotely delivered intervention consisting of digital lessons, sleep tracker, and weekly coaching phone calls by a trained sleep coach. Assessments of sleep (actigraphy), glucose (A1C, continuous glucose monitoring), and patient-reported outcomes (questionnaires for daytime sleepiness, fatigue, diabetes distress, and depressive mood) were completed at baseline and at completion of the intervention. RESULTS: Sleep-Opt-In was feasible and acceptable. Those in Sleep-Opt-In with objectively confirmed short or irregular sleep demonstrated an improvement in sleep regularity (25 minutes), reduced glycemic variability (3.2%), and improved time in range (6.9%) compared to the Healthy Living attention control group. Patient-reported outcomes improved only for the Sleep-Opt-In group. Fatigue and depressive mood improved compared to the control. CONCLUSIONS: Sleep-Opt-In is feasible, acceptable, and promising for further evaluation as a means to improve sleep duration or regularity in the population of people with type 1 diabetes.