Pilot and Feasibility Studies最新文献

{"title":"Cannabidiol to reduce persistent post-surgical pain following total knee arthroplasty: protocol for a multi-centre, randomized, controlled pilot trial.","authors":"Jason W Busse, Breanne Flood, Kim Madden, Vahid Ashoorion, Emmanuel Olaonipekun, Amit Atrey, Vickas Khanna, Anthony Adili","doi":"10.1186/s40814-026-01822-w","DOIUrl":"10.1186/s40814-026-01822-w","url":null,"abstract":"<p><strong>Background: </strong>Total knee arthroplasty (TKA) is commonly performed to reduce pain and improve functional limitations associated with late-stage osteoarthritis. However, 1 in 4 patients experience persistent post-surgical pain (PPSP); a complaint that is associated with higher peri-operative pain. Cannabidiol (CBD) possesses analgesic and anti-inflammatory properties that may reduce the risk of persistent pain among TKA patients. We designed a pilot trial to assess the feasibility of a definitive trial comparing CBT to placebo for reducing PPSP in patients undergoing TKA.</p><p><strong>Methods: </strong>We propose a randomized, controlled, pilot trial in which 40 patients scheduled to undergo TKA will be randomized to receive MPL-001 (an oral CBD-dominant formulation) or placebo, in addition to standard care. The feasibility outcomes of this pilot trial are as follows: (1) our ability to recruit 40 patients in 6 months, (2) achieve ≥75% treatment adherence among patients, and (3) <15% loss to follow-up. Secondary outcomes are the effects of MPL-001 relative to placebo on PPSP, opioid use, peri-operative pain interference, physical and emotional function, return to functioning, sleep, and adverse events (AEs) up to 6 months post-surgery.</p><p><strong>Discussion: </strong>The results of our pilot study will inform the feasibility of a definitive trial to establish the effectiveness of CBD to reduce PPSP after TKA. If no major changes to our protocol are required, we will treat this study as a vanguard trial and enroll our pilot patients into a definitive trial.</p><p><strong>Trial registration: </strong>We prospectively registered our trial on ClinicalTrials.gov (identifier: NCT03825965) before enrolling any patients.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13248386/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147778496","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Get Back, a person-centered digital program to promote physical activity among patients undergoing spinal stenosis surgery: a randomized feasibility study.","authors":"Christian Ernest, Rikard Hanafi, Helena Brisby, Andreas Fors, Håkan Hedman, Mike Kemani, Mari Lundberg, Jo Nijs, Hedvig Zetterberg, Emelie Karlsson","doi":"10.1186/s40814-026-01826-6","DOIUrl":"10.1186/s40814-026-01826-6","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Lumbar spinal stenosis is characterized by walking limitations that often lead to physical inactivity and potentially associated health risks. This trial aimed to examine whether a person-centered digital program targeting physical activity (Get Back feasibility) was feasible and whether it contributed to clinically meaningful improvements in intervention outcomes among patients with LSS who were undergoing surgery.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A two-arm randomized feasibility trial included physically inactive patients ≥ 18 years with central lumbar spinal stenosis scheduled for decompression surgery. The participants were randomized to Get Back or usual physical therapy. The 12-week intervention comprised person-centered support for behavioral changes in physical activity through video and telephone calls with a physical therapist. The feasibility outcomes included process feasibility, resource feasibility, and treatment fidelity, based on data from screening lists, study-specific questions, patient-reported outcome measures, and semi-structured interviews. The outcomes related to the intervention content included objectively assessed steps per day and physical activity, as well as self-reported fear of movement, pain catastrophizing, and general self-efficacy. Process and resource feasibility, as well as tentative changes in post-intervention outcomes, were assessed and reported using descriptive statistics. The temporal relationships of variables during the intervention were analyzed exploratively using cross-lagged correlations. Treatment fidelity, including treatment dose and adherence to the person-centered approach, was evaluated using descriptive statistics and a mixed-methods approach, respectively.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Of the 226 screened patients, 43% (n = 98) fulfilled the screening criteria. Of those, 67 were asked to participate, and 29 were randomized. The most common reason for declining participation was not wanting a digital intervention. The participants found the video format and outcome measures relevant and useful. The response rates were high (92-100%), except for the accelerometer follow-up (76%). The planned primary outcome for the future randomized controlled trial, steps per day, showed tentative between-group differences in favor of the intervention group. In both groups, fear of movement and pain catastrophizing decreased. The intervention participants attended four video sessions and a median of four telephone sessions (3-5). The physical therapists performed the intervention as planned, with fidelity to the person-centered approach, and behavior-change techniques were used.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Get Back was feasible for patients with lumbar spinal stenosis who were receiving decompression surgery, with some modifications to strengthen the overall study procedure and intervention before proceeding to a full-scale randomized controlled trial.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"12 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13107828/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147778502","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol for a feasibility study of a peer support program for trauma survivors.","authors":"Marina B Wasilewski, Logan Reis, Yomna H E Ahmed, Rhea Alitawi, Sander L Hitzig, Amanda L Mayo, Kelly Vogt, Amanda McFarlan, Barbara Haas, Kerry Kuluski, Crystal MacKay, Rob Fowler, Christine L Sheppard, Monica Cassin, David Guo, Lisa Di Prospero, Laurie Legere, Andrew Lawlor, Mary Jane Torrie, Paolo Polese","doi":"10.1186/s40814-026-01820-y","DOIUrl":"10.1186/s40814-026-01820-y","url":null,"abstract":"<p><strong>Background: </strong>Many survivors of traumatic injuries (serious nervous, visceral, bone, and vascular damage due to motor vehicle collisions, falls, sports injuries, electrocution, and fires) also experience mental health issues such as emotional distress, anxiety, and depression. It has been widely accepted that the integration of peers into psychosocial interventions for traumatic injury survivors would provide similar outcomes as cognitive behavioral therapy, while having the benefit of peer lived experience. However, a peer support intervention for trauma survivors has yet to be trialed for feasibility and implemented across the care continuum. Thus, we collaborated with trauma survivors, caregivers, and healthcare professionals (HCPs) to co-design a cross-continuum peer support program (PSP) that we are ready to pilot. The purpose of the study is to (1) assess the acceptability, feasibility, and satisfactoriness of the PSP; (2) evaluate the preliminary impact of the PSP on trauma patients' health and social outcomes; and (3) explore the impact of the PSP on clinical practice, administrative procedures, and patient care.</p><p><strong>Methods: </strong>Feasibility will be determined based on study recruitment, adherence, and retention. Participants will complete outcome surveys at baseline, 1-month post-intervention, and 3-month follow-up. A Repeated Measures ANOVA will be exploratorily used to assess outcome scores at each time point. Qualitative interviews will be completed after the study to explore the acceptability, satisfactoriness, and feasibility of the program. HCPs and TPSs will participate in focus groups to provide insight into the administrative, clinical, and patient care impacts of the PSP. We plan to recruit n = 8-10 Trained Peer Supporters; n = 30 trauma survivors (n = 10-25 to participate in post-intervention qualitative interviews); and n = 15 healthcare professionals (HCPs).</p><p><strong>Discussion: </strong>Based on our existing data and supporting literature, there is strong evidence for the need for a PSP that spans the care continuum and is led by individuals with injury experience. Similar studies conducted with other rehab populations have seen great success with peer support initiatives including the amelioration of psychosocial health and well-being outcomes. Our feasibility trial has the potential to demonstrate that a cross-continuum PSP for trauma survivors is not only feasible, but also successful in reducing the potential adverse psychosocial health outcomes related to traumatic injuries.</p><p><strong>Trial registration: </strong>This trial was registered with ClinicalTrials.gov, registration number NCT07275892 , on December 10th, 2025.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13348980/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147778466","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"App-based self-management program for people dealing with fatigue and trouble concentrating (DiEgO): protocol for participatory development, pilot testing, and qualitative process evaluation.","authors":"Tim Schmachtenberg, Nadja Wegner, Imke Schwalm, Karla Clasen, Katharina Vieth, Tim Riester, Nicole Schmidt, Viktoria Lampe, Zehra Bilgen, Aisha Cook, Frank Müller, Eva Maria Noack, Alexandra Dopfer-Jablonka, Christine Happle, Sandra Steffens, Georg Behrens, Eva Hummers, Andrea Stölting, Torge-Christian Wittke","doi":"10.1186/s40814-026-01821-x","DOIUrl":"10.1186/s40814-026-01821-x","url":null,"abstract":"<p><strong>Background: </strong>Fatigue is a common symptom in both post-COVID syndrome (PCS) and chronic inflammatory rheumatic conditions, associated with physical, cognitive, and mental impairments that reduce quality of life. Evidence-based management approaches remain limited. The DiEgO study addresses this gap by developing an interactive self-management and support application for people with fatigue and trouble concentrating.</p><p><strong>Methods/design: </strong>This study combines a participatory research approach with qualitative methods (content analyses, grounded theory). A development team comprising PCS individuals, occupational therapists, and academic researchers will collaboratively develop the intervention through three iterative cycles. The developed app will then be tested by 20-30 people with rheumatic-disease-related fatigue, assigned to either supported use (with occupational therapy) or independent use. Evaluation includes qualitative interviews with pilot participants to assess usability, feasibility, and acceptability. In addition, the participatory development process will be reflexively evaluated through participant observation and interviews with development team members.</p><p><strong>Discussion: </strong>The DiEgO study will develop an mHealth self-management application for people with fatigue and trouble concentrating. The participatory design involving affected individuals and occupational therapists throughout the development process enhances user-centeredness and real-world applicability. By providing flexible, low-threshold access through an open-source platform, this study may expand accessible self-management support for individuals with post-COVID syndrome and rheumatic conditions.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"12 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13101371/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147778482","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Study protocol, increasing awareness and early detection in students at risk of gynaecological cancer: feasibility of an online educational and behaviour change intervention.","authors":"Patricia Holch, Anne-Marie Bagnall, Seren Hughes, Lauren K McSorley","doi":"10.1186/s40814-026-01801-1","DOIUrl":"10.1186/s40814-026-01801-1","url":null,"abstract":"<p><strong>Background: </strong>Around 2500 teenagers and young adults (TYA) in the UK are diagnosed with cancer each year, many with melanomas or carcinomas. Almost a third are diagnosed via A&E, highlighting the need for earlier detection. Although university students recognise common cancer symptoms, they often miss less obvious ones (e.g. constipation, frequent urination, bloating) and may delay seeking help. Early exposure to cancer information during key life stages, such as university can promote lifelong body awareness and earlier help-seeking. We have created an online behaviour-change intervention for university students, including a gynaecological cancer awareness film and a volitional help sheet to support intention to seek help. The aim is to assess its feasibility and acceptability, explore barriers and enablers to engagement, and refine the intervention ahead of a full UK university rollout.</p><p><strong>Methods: </strong>We will conduct a 1:1 randomised longitudinal mixed-methods feasibility study with 86 eligible UK university participants (women or anyone at risk of gynaecological cancer, aged 18+). Participants will complete an online gynaecological cancer educational film and/or a volitional help sheet via Qualtrics™. Cancer awareness (YPCAM) and Theory of Planned Behaviour measures will be collected at baseline, 4 weeks, 3 months, and 6 months. A subset of the intervention group will take part in semi-structured interviews on barriers and enablers to uptake. Feasibility will be assessed through recruitment and attrition rates, adherence, and study completion. Mean score changes between groups across timepoints will be analysed, adjusting for baseline scores. Interview data will be analysed using reflexive thematic analysis. Progression to a full trial requires achieving at least 80% of the recruitment target.</p><p><strong>Discussion: </strong>Findings from this study will show whether the intervention can improve cancer awareness and help-seeking for gynaecological symptoms among TYA. The long-term aim is to use these insights to support wider adoption of cancer awareness initiatives in universities. Providing cancer information early in students' lives may help them establish lasting habits around body awareness and encourage them to share this knowledge with others.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov from 21/08/2025 https://clinicaltrials.gov/study/NCT07147283 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13227870/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147729468","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Living Memory Home for Dementia Care Pairs (LMH-4-DCP): study protocol for a pilot randomized trial of a web-based reminiscence intervention for family caregivers and persons with dementia.","authors":"Francesca B Falzarano, Annabelle Greenfield, Sydney C Saviano, Sindhu Kolla, Sosi Korian, Francesco Osso, Joseph Miller, Paul K Maciejewski, Heather E Whitson, Holly G Prigerson","doi":"10.1186/s40814-026-01781-2","DOIUrl":"10.1186/s40814-026-01781-2","url":null,"abstract":"<p><strong>Background: </strong>Family caregivers provide most of the emotional, physical, and logistical support for people living with Alzheimer's disease and related dementias (ADRD). As the caregiving role intensifies with advancing illness, family caregivers navigate the cognitive and functional decline of the care recipient. They also must reconcile the shift from a mutual relationship to one of a primary caregiving role. The unique nature of ADRD makes pre-death grief highly prevalent among family caregivers. Reminiscence therapy, which uses memory prompts to evoke meaningful past experiences, has shown promise in improving psychosocial outcomes for individuals with dementia. Its potential to benefit caregivers through strengthened emotional connections, shared meaning, and mutual engagement among the dyad, however, has been largely underexplored. Guided by the Interdependence Model of Communal Coping and the Micro-Sociological Theory of Adjustment to Loss, the current study aims to assess the feasibility and acceptability of Living Memory Home for Dementia Care Pairs (LMH-4-DCP), a reminiscence-based online intervention for family caregivers and their care-recipients.</p><p><strong>Methods: </strong>This multisite pilot randomized controlled trial (RCT) will evaluate the feasibility, acceptability, and preliminary efficacy of LMH-4-DCP. Seventy ADRD family caregivers will be targeted for randomization to a 1:1 ratio to the intervention (n = 35) or attention control (n = 35) conditions and will participate for 2 weeks. Recruitment will be facilitated by the project's two study sites located in urban metropolitan areas of the USA. Primary feasibility outcomes include recruitment, retention, and completion rates, website usability (e.g., perceived usefulness and ease of use), and intervention satisfaction. Exploratory analyses will be conducted to assess the preliminary efficacy of LMH-4-DCP in reducing pre-death grief and improving relationship quality. Outcomes will be measured using validated questionnaires at baseline and 2-week follow-up, along with semi-structured interviews with LMH-4-DCP participants.</p><p><strong>Discussion: </strong>This pilot trial will offer foundational evidence regarding the feasibility and acceptability of the LMH-4-DCP intervention. Study findings will guide intervention refinements and inform the design of a larger-scale, fully powered RCT to evaluate its efficacy in reducing pre-death grief and enhancing relationship quality among ADRD family caregivers.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov: NCT06225986, Registered: January 9, 2024, ClinicalTrials.gov; https://clinicaltrials.gov/study/NCT06225986?term=living%20memory%20home&rank=1.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13191886/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147675869","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"KiVa-SEND: protocol for a two-arm feasibility cluster randomised controlled trial of an adapted anti-bullying programme for special schools.","authors":"Julia R Badger, Lucy Bowes, Christina Salmivalli, Ariel Lindorff, Caitlin Murray, Richard P Hastings","doi":"10.1186/s40814-026-01813-x","DOIUrl":"10.1186/s40814-026-01813-x","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Bullying is a public health risk with rates amongst pupils in mainstream school estimated to be about 20-30%. This increases to approximately 25-69% amongst pupils with special educational needs and disabilities (SEND). Combined bullying data from two large studies of children and young people from 144 countries found that the greatest risk factor to becoming a victim of bullying was being 'different' to one's peers. These differences included factors such as physical appearance, physical disability or learning disability. Yet there are currently no evidence-based anti-bullying programmes designed specifically for pupils in special schools, and therefore no randomised controlled trials. This study adapted KiVa - an established and evidence-based Finnish anti-bullying programme of ten, 1.5 h lessons that can be embedded into a school curriculum - into KiVa-SEND, by adjusting the language, activities and teaching delivery.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A two-arm feasibility cluster interventional randomised controlled trial with a 1:1 blocked randomisation allocation ratio of schools and an embedded process evaluation. Data will be collected at baseline and at a 12-month follow-up. Eight UK special education schools will participate with between 128 and 384 pupils and between 16 and 96 teachers completing the data questionnaires. A further three to six teachers and up to 10 pupils will participate in the process evaluation interviews or Talking Mats. Talking Mats is a visual tool to support individuals who struggle with communication, to express their thoughts and emotions. Four schools will be allocated to implement KiVa-SEND across the academic year 2025/26 in addition to anti-bullying practice as usual, and four schools will continue with usual practice alone. Primary outcomes will be feasibility outcomes on the topics of recruitment and retention, adherence, staff surveys, pupil surveys and pupil attendance. Secondary outcomes will focus on pupil survey data, teacher survey data, and the differences between KiVa-SEND and the schools' current anti-bullying programmes. The process evaluation will focus on the topics of recruitment and retention, implementation and adherence of the adapted KiVa programme, engagement and acceptability of/to pupils and staff, and suitability of the outcome measures.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;This feasibility cluster randomised controlled trial with embedded process evaluation will evaluate the feasibility of delivering KiVa-SEND within a variety of UK special schools, the acceptance of the materials, and the suitability of the outcome measures, for pupils aged 7-14 with a range of primary educational needs and learning disabilities. This will inform the feasibility to later conduct a definitive randomised controlled trial of the effectiveness of KiVa-SEND.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;ISRCTN, ISRCTN15516577. Registered 31 March 2025 before any data collection,","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13188377/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147662712","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pilot study of the DeStress for Health Program: a community-engaged stress reduction and cancer prevention intervention for rural communities.","authors":"Devon Noonan, Amnazo Muhirwa, Elaine Sang, Nicole Calhoun, Ardis Crews, Kellen Peter, Henry Crews, Lucette Mercer, Lisa Macon Harrison, Shauna L Guthrie, Kathryn I Pollak","doi":"10.1186/s40814-026-01811-z","DOIUrl":"10.1186/s40814-026-01811-z","url":null,"abstract":"<p><strong>Background: </strong>Stress related to personal, social, and environmental factors has been linked to engaging in unhealthy behaviors. These behaviors may increase cancer risk. Most current prevention programs do not address stress related to social factors and related stresses that are driving unhealthy behaviors. The purpose of this study was to pilot the DeStress for Heath Program.</p><p><strong>Methods: </strong>We conducted a pilot randomized controlled trial. Community members from two rural counties were randomized to the DeStress for Health Program group or a waitlist control group. The DeStress for Health Program, developed using a community engaged approach, is a 4-class, in-person, nurse delivered evidenced-based intervention that uses both positive psychology and health behaviour goal setting to address stress reduction and cancer risk behaviours. We offered the program to the waitlist control group after completion of all assessments. Self-report surveys were completed at baseline and 30 days post-intervention in the DeStress arm to assess feasibility and acceptability and 30 days post 4-week wait time in the control. Study outcomes for feasibility included recruitment, retention, and engagement, and acceptability included positive endorsement of the intervention and changes in stress and health behaviours.</p><p><strong>Results: </strong>We recruited 29 participants in 6 months, missing our feasibility recruitment benchmark. We did not meet our feasibility benchmark of having 75% of participants attend all 4 classes, with 69% of residents attended at least 2 classes. We retained 21 of 29 (72%) participants at follow-up. Acceptability results include the DeStress group reported that the intervention reduced daily stress (n = 13, 81.3%), helped encourage better nutrition (n = 15, 93.8%) and physical activity (n = 15, 93.8%), and would recommend the program to a friend (n = 15, 93.8%). DeStress improved scores on the Perceived Stress Scale over time compared to the waitlist control.</p><p><strong>Discussion: </strong>The DeStress intervention is acceptable and demonstrates improvements in stress. Feasibility benchmarks were not all met, and suggestions for future adaptations to improve feasibility are discussed. DeStress underscores the importance of developing programs that address real community needs and linking intervention programs with community resources, particularly in rural communities where health-related resources can be scarce.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier: NCT03776890.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13188702/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147654239","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Conversation cards for pregnancy: a protocol for a multi-method study.","authors":"Angela S Alberga, Vida Forouhar, Valentina Lurye, Kristi B Adamo, Susan Avery, Geoff D C Ball, Biagina-Carla Farnesi, Laura Gaudet, Taniya S Nagpal, Helena Piccinini-Vallis, Ximena Ramos Salas, Ryan E Rhodes, Michael Vallis, Jocelynn Cook, Taryn M Graham, Karah Stanworth-Belleville, Tamara R Cohen","doi":"10.1186/s40814-026-01793-y","DOIUrl":"10.1186/s40814-026-01793-y","url":null,"abstract":"<p><strong>Background: </strong>Conversations regarding health behaviours, mental health, and socioeconomic contexts are recommended during prenatal visits to optimize maternal and fetal health outcomes. This study was designed to develop and evaluate the acceptability of a clinical dialogue tool called Conversation Cards for Pregnancy (PregnancyCards for short). PregnancyCards are being designed as a practical, person-centered clinical dialogue tool to empower pregnant individuals to talk with their prenatal care providers about potentially sensitive topics regarding health behaviours that are important to them during their prenatal visits.</p><p><strong>Methods: </strong>This two-step, 3-year, multi-method study, guided by the Obesity-Related Behavioural Interventions Trial (ORBIT) model, is grounded in the Capability, Opportunity, and Motivation (COM-B) framework for understanding behaviour. Pregnant individuals and prenatal care providers will be recruited by our partners from across Canada, in clinical and community settings. Step 1: Identify topics of interest related to health behaviours by conducting virtual semi-structured interviews with pregnant individuals (n ~ 20) and prenatal health care providers (n ~ 10-15) and by analyzing data using thematic analysis. Step 2: Topics generated in Step 1 will be used to create a prototype deck of PregnancyCards that will be evaluated in clinical settings with pregnant individuals (n ~ 40) to assess acceptability, appropriateness, and feasibility, and qualitative experiences of using the cards. Prenatal care providers (n ~ 15) will be recruited at one time point to capture their perceptions of usability, acceptability and likability of the prototype cards as well.</p><p><strong>Results: </strong>Currently, a total of 21 pregnant individuals and 14 prenatal care providers have already participated in Step 1 of this study. All participants (pregnant individuals and prenatal care providers) engaged in semi-structured interviews to determine the topics of interest related to health behaviours. Thematic analysis of interview data has been completed and the results informed the development of a prototype deck of PregnancyCards, which will be tested in Step 2.</p><p><strong>Discussion: </strong>We seek to gain a better understanding of pregnant individuals' perceived needs for conversations related to health behaviours and provide insight into the acceptability, appropriateness, and feasibility of PregnancyCards in clinical settings. PregnancyCards has the potential to serve as a practical clinical dialogue tool to help empower pregnant individuals and optimize discussions about health behaviours that matter to them during pregnancy. The two studies outlined in this protocol paper will inform future research to test the efficacy and effectiveness of PregnancyCards as a behavioural intervention aimed at improving health behaviours in pregnancy.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13188653/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147654260","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Gamified sensor-based upper extremity functional rehabilitation in individuals with spinal cord injury: a pilot clinical trial protocol.","authors":"Sunpreet Singh Hanspal, Gouree Sengar, Ankush Gera, Harvinder Singh Chhabra, Ankit Sharma","doi":"10.1186/s40814-026-01818-6","DOIUrl":"10.1186/s40814-026-01818-6","url":null,"abstract":"<p><strong>Background: </strong>Spinal cord injury (SCI) is a life-altering condition that impacts physical, functional, and psychosocial well-being. Regardless of the cause, restoring hand function is the first priority for tetraplegic people which tend to place more emphasis on independence and activity limitations in activities of daily living (ADL) in SCI. Traditional rehabilitation strategies often result in limited motor recovery, highlighting the need for adjunctive approaches. Emerging evidence suggests that gamified sensor-based interventions may augment conventional therapy by increasing patient engagement, enhancing neuroplasticity, and supporting motor relearning through task-specific, interactive training paradigms.</p><p><strong>Methods: </strong>This single-arm, single-center pilot study is primarily designed to evaluate the feasibility of delivering gamified sensor-based upper extremity rehabilitation in individuals with cervical spinal cord injury (SCI). Feasibility parameters include recruitment and retention rates, adherence to the intervention, and participant satisfaction. Twenty participants aged 18-65 years with cervical SCI (AIS A-D) will be recruited. The intervention comprises 25 sessions over 5 weeks using a gamified sensor-based rehabilitation system. Secondary, exploratory objectives will examine preliminary trends in motor and functional outcomes through descriptive statistics and effect size estimation.</p><p><strong>Discussion: </strong>Findings from this study will provide preliminary feasibility data on the implementation of gamified sensor-based upper extremity rehabilitation in individuals with SCI. Results will help refine the methodological design for a future adequately powered randomized controlled trial.</p><p><strong>Trial registration: </strong>Registered at ClinicalTrials.gov - CTRI/2025/06/088222.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13179612/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147639529","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}