Impact of a resilience-building energy management intervention for people with systemic sclerosis: a mixed methods study.

Objectives: People with SSc often experience fatigue, which significantly affects daily life functioning and quality of life. We aimed to explore participants' experiences of a peer health-coached resilience-building energy management to enhance well-being (RENEW) intervention on symptoms and well-being and to use mixed methods to compare how SSc duration influenced the experiences of participants who had clinically significant fatigue improvement vs those who did not. Methods: Semi-structured interviews were conducted with 21 participants from the parent clinical trial randomized to the RENEW intervention. Data were analysed using the rigorous and accelerated data reduction technique combined with thematic content analysis. A mixed methods approach used a joint display to identify themes related to the impact of SSc duration on fatigue improvement status. Participants were categorized into short/improvement, short/limited improvement, long/improvement, and long/limited improvement. Results: Our team generated four themes: participant and peer health-coach relationship, physical and psychological well-being improvement, need for a tailored approach and easy program access through technology. Mixed methods analysis revealed that, regardless of SSc duration, participants with improved fatigue reported increasing self-awareness of SSc-related symptoms and learning coping strategies to manage fatigue. Participants in the short/improvement group reported preferences for slower pacing of the program and pairing with a coach with similar symptom severity. Participants in the long/limited improvement group sought SSc-specific symptom management information. Conclusion: Incorporating peer health coaches and technology is beneficial for self-management interventions for people with SSc. Future tailoring of RENEW based on SSc duration and symptom severity is needed. Clinical trial registration number: clinicatrials.gov, NCT04908943.

Updating and evaluating a research best practices training course for social and behavioral research professionals.

Introduction: The clinical and translational research workforce involved in social and behavioral research (SBR) needs to keep pace with clinical research guidance and regulations. Updated information and a new module on community and stakeholder engagement were added to an existing SBR training course. This article presents evaluation findings of the updated course for the Social and Behavioral Workforce. Methods and Materials: Participants working across one university were recruited. Course completers were sent an online survey to evaluate the training. Some participants were invited to join in a focus group to discuss the application of the training to their work. We performed descriptive statistics and conducted a qualitative analysis on focus group data. Results: There were 99 participants from diverse backgrounds who completed the survey. Most reported the training was relevant to their work or that of the study teams they worked with. Almost half (46%) indicated they would work differently after participating. Respondents with community or stakeholder engaged research experience vs. those without were more likely to report that the new module was relevant to study teams they worked with (t = 5.61, p = 0.001), and that they would work differently following the training (t = 2.63, p = 0.01). Open-ended survey responses (n = 99) and focus group (n = 12) data showed how participants felt their work would be affected by the training. Conclusion: The updated course was rated highly, particularly by those whose work was related to the new course content. This course provides an up-to-date resource for the training and development for the Social and Behavioral Workforce.

Effects of a Resilience-Building Energy Management Program on Fatigue and Other Symptoms in Systemic Sclerosis: A Randomized Controlled Trial.

OBJECTIVE: Supported self-management interventions for individuals with systemic sclerosis (SSc) are needed. We examined the effects of a 12-week resilience-building energy management program (called RENEW) for fatigue and other patient-reported outcomes. METHODS: Participants, who had physician-diagnosed SSc, moderate to severe fatigue, and were ≥18 years old, were randomly assigned to RENEW or waitlist control in a 2:1 ratio. The RENEW intervention included an educational website/application plus nine virtual peer-led health coaching sessions. The primary outcome was change in the Functional Assessment of Chronic Illness Therapy-Fatigue scale. Secondary outcomes were change in Patient Reported Outcomes Measurement Information System measures of pain interference and depressive symptoms and Connor-Davidson Resilience Scale. Outcomes were assessed at baseline, 6 weeks, and 12 weeks. Multiple imputation was conducted; linear mixed models were used to assess group differences. A three-way interaction with group, time, and SSc duration was examined in each model. RESULTS: Among 173 participants (mean ± SD age 54.5 ± 11.7 years; 93% female, 85% White), 47% had diffuse cutaneous SSc; 57% were ≤5 years from diagnosis. At 12 weeks, compared to controls, RENEW participants had a clinically meaningful fatigue improvement (ß = -4.7; 95% confidence interval -6.7 to -2.7; P < 0.001) and improvement in all secondary outcomes. Among RENEW participants, individuals with shorter disease duration had greater improvements in fatigue at 12 weeks. CONCLUSION: An mHealth supported self-management intervention improved fatigue and other outcomes, particularly in newly diagnosed patients. This program may be broadly scalable for SSc symptom management.

Evaluation of an online research best practices training for community health workers and promotoras.

Introduction: Community health workers and promotoras (CHW/Ps) have a fundamental role in facilitating research with communities. However, no national standard training exists as part of the CHW/P job role. We developed and evaluated a culturally- and linguistically tailored online research best practices course for CHW/Ps to meet this gap. Methods: After the research best practices course was developed, we advertised the opportunity to CHW/Ps nationwide to complete the training online in English or Spanish. Following course completion, CHW/Ps received an online survey to rate their skills in community-engaged research and their perceptions of the course using Likert scales of agreement. A qualitative content analysis was conducted on open-ended response data. Results: 104 CHW/Ps completed the English or Spanish course (n = 52 for each language; mean age 42 years SD ± 12); 88% of individuals identified as female and 56% identified as Hispanic, Latino, or Spaniard. 96%-100% of respondents reported improvement in various skills. Nearly all CHW/Ps (97%) agreed the course was relevant to their work, and 96% felt the training was useful. Qualitative themes related to working more effectively as a result of training included enhanced skills, increased resources, and building bridges between communities and researchers. Discussion: The CHW/P research best practices course was rated as useful and relevant by CHW/Ps, particularly for communicating about research with community members. This course can be a professional development resource for CHW/Ps and could serve as the foundation for a national standardized training on their role related to research best practices.

Risk factors for reduced function in women with a history of breast cancer.

PURPOSE: People with a history of breast cancer are at risk of losing function during and after treatment. Unfortunately, little is known about the individual and additive effects of specific treatment, disease-related, and demographic factors that may contribute to functional decline. This manuscript reports the results of a multi-center study to evaluate the effects of these factors on function. METHODS: In this cross-sectional study, women with a history of breast cancer referred to physical medicine and rehabilitation cancer rehabilitation clinics were administered the PROMIS® Cancer Function Brief 3D Profile to evaluate function in the domains of physical function, fatigue, and social participation. Clinical and demographic information, including treatment history and disease status, was recorded by clinicians. Patients were analyzed in two groups: those with active disease on antineoplastic treatment, and those with no evidence of disease (NED). A multivariable model was constructed to detect associations between clinical and demographic factors. RESULTS: In patients with NED, the presence of chemotherapy-induced peripheral neuropathy (CIPN) was strongly associated with reduced function in all three domains. In those with active disease, having brain metastases was significantly associated with reduced function in all domains and CIPN with reduced physical function. Radiation was associated with improved function in both cohorts. CONCLUSIONS: Among women seeking rehabilitative care, CIPN and the presence of brain metastases were most strongly associated with a decline in function. The effects of radiation on function were unexpected and may be partially explained by the treatment's role in symptom management. Clinicians who treat breast cancer should consider a patient's functional status when providing supportive care.

Development and pilot test of a pregnancy decision making tool for women with physical disabilities.

OBJECTIVE: Design and pilot test a new decision making tool for women with physical disabilities (impairment of physical function due to chronic conditions) considering pregnancy. DATA SOURCES AND STUDY SETTING: Quantitative surveys and qualitative interviews were collected from participants living in the community. STUDY DESIGN: Clinical guidelines and survey and focus group data about pregnancy informational and decisional needs guided content development. The tool was pilot tested in a 12-week trial with participants with physical disabilities considering or actively planning a pregnancy. Feasibility outcomes were acceptability, implementation, and demand (collected at end of the trial); preliminary efficacy focused on decisional conflict and readiness (baseline, 6 weeks, and end of trial). DATA COLLECTION: Survey data were collected using an online form. One-on-one interviews were conducted to learn more about experience using the tool. PRINCIPAL FINDINGS: Thirty eight participants with mild, moderate, or severe physical disabilities participated. Feasibility outcomes indicated that the tool provided participants with information, guiding questions, and helped them to consider multiple aspects of the decision about pregnancy. Most participants responded positively to the new decision making tool, finding it easy to use and the information balanced. Feedback highlighted opportunity for improvement, such as more specific information, peer stories, and the limitations of a paper format. There was significant linear effect of time, with increased decisional certainty and readiness, values clarity, and decisional support (partial η2 [90% CI] = 0.310 [0.08, 0.46], 0.435 [0.19, 0.60], 0.134 [0, 0.29], 0.178 [0.01, 0.35], respectively). Decisional certainty and readiness had high observed power (96.7% and 99.3%, respectively) with lower observed power for clarity and support (60.6% and 75.1%, respectively). CONCLUSIONS: The new tool shows promise for supporting women with physical disabilities in navigating pregnancy decision making. Future development of complementary strategies to support health care providers will help improve shared decision making and patient-centered care.

Responsiveness and interpretation of the PROMIS Cancer Function Brief 3D Profile.

BACKGROUND: Measuring function with valid and responsive tools in patients with cancer is essential for driving clinical decision-making and for the end points of clinical trials. Current patient-reported outcome measurements of function fall short for many reasons. This study evaluates the responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS) Cancer Function Brief 3D Profile, a novel measure of function across multiple domains. METHODS: Two hundred nine participants across five geographically distinct tertiary care centers completed the assessment and pain rating at two outpatient cancer rehabilitation clinic visits. Patients and providers completed a global rating of change measure at the second visit to indicate whether the patient was improving or worsening in function. Multiple response indices and linear models measured whether the measure was responsive to self-reported and clinician-rated changes over time. Correlations between changes in function and changes in anchors (pain rating and performance status) were also calculated. RESULTS: Function as measured by the PROMIS Cancer Function Brief 3D Profile changed appropriately as both patients and clinicians rated change. Small to moderate effect sizes supported the tool's responsiveness. Function was moderately correlated with pain and more strongly correlated with performance status, and changes in function corresponded with changes in anchor variables. No floor/ceiling effect was found. CONCLUSIONS: The PROMIS Cancer Function Brief 3D Profile is sensitive to changes over time in patients with cancer. The measure may be useful in clinical practice and as an end point in clinical trials. LAY SUMMARY: We gave patients a questionnaire by which they told their physicians how well they were functioning, including how fatigued they were. This study tested that questionnaire to see whether the scores would change if patients got better or worse.

Psychometric Characteristics and Validity of the PROMIS Cancer Function Brief 3D Profile.

OBJECTIVE: To develop an item response theory (IRT)-calibrated, patient-reported outcome measure (the PROMIS Cancer Function Brief 3D Profile) of physical function, including associations with fatigue and social participation, in cancer rehabilitation patients. DESIGN: Large-scale field testing, graded response model IRT analyses, and multivariate regression analysis. SETTING: Six cancer rehabilitation clinics associated with cancer centers across the United States. PARTICIPANTS: Adults (N=616) treated in outpatient cancer rehabilitation medicine clinics. INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: The PROMIS(r) Cancer Function 3D Profile (including existing items from PROMIS(r) item banks). RESULTS: A total of 616 patients completed 21 items in the initial item pool. Nine items were removed because of comparatively lower information that they provide according to the IRT item calibrations, low item-total correlations, or bimodal distributions. The remaining items generated a 12-item short form. Regression analyses determined that the items were responsive to and representative of the patient population across trait ranges and multiple domains and subdomains of function. CONCLUSIONS: This psychometric investigation supports the use of the PROMIS Cancer Function Brief 3D Profile for evaluating function in outpatient cancer rehabilitation patients.

Development of a new pregnancy informational and decisional needs survey for women with physical disabilities.

BACKGROUND: While the literature on pregnancy and disability is growing, generating important knowledge of barriers to care and health risks, there is limited literature on pregnancy decision-making and informational needs. Such knowledge is critical for the development of interventions to mitigate the challenges women with disabilities and health care providers face in making this important decision. OBJECTIVE: /Hypothesis: Develop a survey of pregnancy decisional and informational needs of women with physical disabilities. METHODS: We developed a conceptual framework that guided item writing, defined the characteristics of the target population, engaged stakeholders with disabilities to collaborate with investigators, and tested the interpretability and relevance of items, and preferred mode of responding (online vs. telephone). A total of 123 women participated in cognitive interviews (N = 13), mode testing (N = 10), or survey data collection (N = 114). RESULTS: Instructions, three screening questions, and 156 items were tested in one round of 17 cognitive interviews; 25 items were deleted, 94 were revised, and 37 items were retained without changes. The final version of the survey included six sub-sections: the experience of making a decision; information about pregnancy and disability; things affecting a decision; knowing what is important; support for making a decision; and working with health care providers. CONCLUSIONS: The overall performance of the survey supported its content validity and utility as a useful way to gather information about the pregnancy decision-making experience and informational needs of women with physical disabilities.

Patient and Provider-Reported Satisfaction of Cancer Rehabilitation Telemedicine Visits During the COVID-19 Pandemic.

INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic has accelerated the growth of telemedicine services across the United States. In this study, we examined cancer rehabilitation patient and physician satisfaction with telemedicine visits. We also sought to evaluate the types of provider services that are given during telemedicine visits. OBJECTIVE: To assess overall patient and provider satisfaction with telemedicine visits and explore whether satisfaction varied by contact method (phone or video) and encounter type (new problem, worsening problem, stable/improving problem). DESIGN: Prospective survey study. SETTING: Cancer rehabilitation program at an academic medical center. PARTICIPANTS: Three cancer rehabilitation providers and 155 unique patients participated in the study. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Provider and patient satisfaction measured by customized surveys. RESULTS: One hundred eighty-four encounters with 169 unique patients were scheduled. Of these, 14 were new visits and 170 were follow-up visits. Eighteen encounters (9.8%) were either no shows or rescheduled, making for 166 encounters with 155 unique patients. Patient and provider responses comprised the following: 94.8% of patient responses reported "quite a bit" or "very much" for the telemedicine visit being a good experience; 63.1% of patient responses reported "quite a bit" or "very much" for interest in using telemedicine visits in the future; and 83.9% of provider responses reported "quite a bit" or "very much" for the patient's main problem being addressed by the visit. Providers were more likely to prefer an in-person visit for a new or worsening problem versus a stable/improving problem. The most common services provided were medication prescription/titration and education/counseling. The least common services provided were making of new diagnoses, ordering interventional procedures, and making referrals. CONCLUSION: Telemedicine visits were well received by both patients and providers in a cancer rehabilitation medicine clinic setting. However, in the case of a new or worsening problem, satisfaction declined. These data support that telemedicine visits should be considered essential as part of comprehensive cancer rehabilitation care, especially during a public health crisis.

The Cancer Rehabilitation Medicine Metrics Consortium: A Path to Enhanced, Multi-Site Outcome Assessment to Enhance Care and Demonstrate Value.

PURPOSE: A primary objective stated at the Cancer Rehabilitation Symposium at the National Institutes of Health was to improve outcome measurement. The purpose of this project was for the Cancer Rehabilitation Medicine Metrics Consortium (CRMMC) to develop an assessment tool to evaluate function in cancer patients via a data-driven and methodologically sound process. There is no agreed-upon measure of physical and cognitive function for cancer patients, making it difficult to demonstrate the value of rehabilitation interventions. Cancer patients are a particularly challenging population, with many tumor- and treatment-related variables impacting function. METHODS: Investigators from nine different cancer rehabilitation programs participated in a modified-Delphi process to delineate necessary aspects of an ideal patient assessment tool, including instrument type, domains evaluated, applicability across a range of patient traits, clinical feasibility, and item response characteristics. This involved numerous meetings, data review, and analysis of items involved in patient assessment. RESULTS: The CRMMC developed a 21-item patient-reported outcome measure based on item response theory. The process by which the short form was developed was documented and provides a framework for other clinicians to follow. CONCLUSION: This document provides a framework for rehabilitation providers to follow when developing an assessment tool. This process is described in a stepwise fashion for reproducibility even in different, non-cancer populations.

Longitudinal Change and Prediction of Everyday Task Competence in the Elderly.

The present study examined longitudinal change in everyday task competence in a sample of 102 community-dwelling older adults from central Pennsylvania. Subjects were assessed on cognitive abilities, intellectual control beliefs, and everyday task competence in 1979 and 1986. The results indicated significant mean level decline on everyday task competence. However, wide individual differences were apparent in the timing and rate of decline; 62% of the sample remained stable or improved in competence over this seven-year period. Structural equation analyses were conducted to examine lagged relationships among the ability, intellectual control, and everyday task competence constructs. Fluid reasoning ability was a significant longitudinal predictor of subsequent everyday task competence. Everyday task competence was a significant longitudinal predictor of subsequent self-efficacy beliefs regarding intellectual aging. The results suggest that mean level decline in everyday task competence may not represent the intraindividual developmental trajectory of many subjects. Prior level of fluid ability influences subsequent everyday task competence, and prior level of everyday task competence influences levels of self-efficacy beliefs.