Pilot and Feasibility Studies最新文献

{"title":"Developing and testing the feasibility of a theory-based brief counseling intervention to promote physical activity in breast cancer survivors enrolled in the PAC-WOMAN trial.","authors":"Sofia Franco, Eliana V Carraça, Inês Nobre, Bruno Rodrigues, Vítor Ilharco, Lea Kahlert, Marlene N Silva","doi":"10.1186/s40814-024-01587-0","DOIUrl":"10.1186/s40814-024-01587-0","url":null,"abstract":"<p><strong>Background: </strong>Despite the benefits of physical activity (PA), cancer survivors report engagement barriers, and existing interventions often lack comprehensive solutions. Theory-based interventions using evidence-based behavior change techniques (BCTs) have been shown to be effective in promoting PA for breast cancer survivors, although their feasibility and acceptability lack evidence. The PAC-WOMAN trial is a three-arm randomized controlled trial aimed at promoting short- and long-term PA and improving the quality of life of breast cancer survivors. This study describes the development of a brief counseling theory-based motivational intervention from the PAC-WOMAN trial, assessing its feasibility and acceptability.</p><p><strong>Methods: </strong>A broad search of theory-based interventions for people with chronic diseases was conducted. Key strategies from each intervention helped shape the main components and BCTs used in the eight bimonthly sessions of the PAC-WOMAN brief counseling intervention, which was based on self-determination theory principles and aimed at empowering participants to develop self-regulation resources for PA through basic psychological needs satisfaction. A toolkit and manuals for intervention facilitators and participants were developed. A feasibility study was conducted to monitor implementation fidelity, acceptability, adherence, and participants' experiences (via a focus group).</p><p><strong>Results: </strong>Twelve women (mean age 55.9 ± 6.7 years) participated. Implementation monitoring indicated that the intervention was feasible. The attrition rate was 25%. Focus-group discussion suggested that weekly sessions would increase attendance, highlighted the helpfulness of self-monitoring and the importance of role models for PA, and identified the session on safely exercising at home as key in improving PA levels.</p><p><strong>Conclusions: </strong>This research aims to enhance systematic reporting in intervention development by detailing the specific BCTs used, translating them into implementation strategies, providing comprehensive resources for facilitators/participants, and supporting the implementation, dissemination, and adoption of a theory-based intervention informed by previous research. Feasibility testing suggests that the intervention was well accepted by participants and feasible, although it could benefit from adjustments in format to increase compliance.</p><p><strong>Trial registration: </strong>NCT05860621, registered 20 April 2023 - retrospectively registered, https://clinicaltrials.gov/study/NCT05860621 . Registered 21 April 2023 - retrospectively registered, https://doi.org/10.17605/OSF.IO/ZAQ9N . UMIN000050945, registered 27 April 2023 - retrospectively registered, https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058070 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"4"},"PeriodicalIF":1.5,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724545/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142971920","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":"Japi 2.0, a gaming platform to stimulate cognitive and non-cognitive skills in early childhood: protocol for a pilot randomized controlled trial.","authors":"Jorge Gaete, Saray Ramírez, Cristian A Rojas-Barahona, Valentina Romo, Natalia Ríos, Ricardo Araya","doi":"10.1186/s40814-025-01593-w","DOIUrl":"10.1186/s40814-025-01593-w","url":null,"abstract":"<p><strong>Background: </strong>Mental health disorders are one of the leading causes of illness globally. The importance of psychosocial skills acquired in early childhood, such as executive functions, inhibitory control, emotional regulation, and social problem-solving, in preventing mental disorders has been reported. Furthermore, mental health care delivery is evolving, and mobile technology is becoming the medium for assessment and intervention. We have developed Japi 2.0, the second iteration of a gaming platform, to stimulate cognitive and non-cognitive skills in early childhood, supported by early years educators using a web-based dashboard integrated into one system. This study aims to assess the acceptability and feasibility of this gaming platform and web-based dashboards.</p><p><strong>Methods: </strong>This is a pilot randomized controlled trial, parallel-group type, where the school-based implementation of \"Japi 2.0\" training is compared to standard school curricula in control schools. A total of six schools with low socio-economic status located in the city of Santiago, Chile, are expected to be recruited and randomized with 1:1 allocation. Japi 2.0 has 24 sessions, and 2 sessions of 15 min per week are delivered for 12 weeks. Measures will be conducted using different instruments with children, parents, and early years educators to gain insight into their acceptance of the intervention and the development of cognitive and non-cognitive skills.</p><p><strong>Discussion: </strong>This is a randomized control trial to assess the acceptability and feasibility of a gaming platform called \"Japi 2.0\" among preschoolers in Chile. This platform stimulates cognitive and non-cognitive skills with the final objective of reducing emotional and behavioral problems in early childhood. Evaluating the acceptability and feasibility of this technological solution for children is expected to produce relevant information about these novel designs. It may help guide future studies, such as a randomized controlled trial on a larger scale.</p><p><strong>Trial registration: </strong>Clinical Trials NCT06420544, May 20, 2024 [ https://www.</p><p><strong>Clinicaltrials: </strong>gov/study/NCT06420544 ].</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"5"},"PeriodicalIF":1.5,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724557/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142971922","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":"Cognitive Behavioural Therapy to Optimize Post-Operative Recovery (COPE): a randomized controlled feasibility trial in extremity fracture patients.","authors":"Kyle Gouveia, Sheila Sprague, Jodi L Gallant, Sarah MacRae, Gina Del Fabbro, Sofia Bzovsky, Paula McKay, Herman Johal, Jason W Busse","doi":"10.1186/s40814-024-01592-3","DOIUrl":"10.1186/s40814-024-01592-3","url":null,"abstract":"<p><strong>Background: </strong>Outcomes following surgery to operatively manage extremity fractures are variable, and up to two-thirds of patients report chronic post-surgical pain. Preliminary evidence suggests that psychotherapy directed at improving coping skills and reducing somatic vigilance may improve outcomes among fracture patients. The objective of this pilot study was to test the feasibility and acceptability of a randomized controlled trial comparing an online cognitive behavioural therapy (CBT) program versus usual care in patients with an operatively managed open or closed extremity fracture.</p><p><strong>Methods: </strong>We conducted a single-centre internal pilot study over a 10-month period in patients with at least one operatively managed open or closed fracture of the appendicular skeleton. Participants were randomized to an online CBT program or usual care and followed for 12 months. The goals of our pilot study were to determine an acceptable rate of recruitment, the degree to which participants randomized to CBT were compliant with treatment, the site investigator's ability to adhere to study protocol and data collection procedures, and our ability to achieve high follow-up rates. Feasibility criteria were evaluated using a graded \"traffic light\" approach, in which \"green light\" indicates moving forward with the definitive trial, \"yellow light\" indicates proceeding with modifications to the protocol and trial procedures, and \"red light\" indicates a definitive trial is not feasible without significant protocol and trial procedure modifications.</p><p><strong>Results: </strong>We enrolled 94 participants over 10 months, which resulted in a \"yellow light\" for recruitment. Participant compliance with completion of the online CBT program received a \"yellow light\", with 60% of participants who were randomized to CBT completing all seven modules. However, 40% of participants in the CBT-arm withdrew from the program, resulting in a \"red light\". Adherence with the study protocol activities at baseline was relatively high (88%) which resulted in a \"yellow light\". Follow-up was 85% (80 of 94) at 12 months, resulting in a \"yellow light\".</p><p><strong>Conclusions: </strong>These results suggest feasibility of a definitive, multi-centre trial to compare CBT versus usual care in the management of persistent post-operative pain in fracture patients despite the pilot phase identifying some challenges with enrollment timelines, compliance with the CBT program, and participant follow-up. For the definitive trial, we will expand participant recruitment to additional centres and implement strategies to optimize participant engagement and compliance with the CBT program and follow-up.</p><p><strong>Trial registration: </strong>ClincialTrials.gov (NCT04274530). Registered February 18, 2020, https://classic.</p><p><strong>Clinicaltrials: </strong>gov/ct2/show/NCT04274530 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"3"},"PeriodicalIF":1.5,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724510/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142971918","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":"Laparoscopic and Endoscopic cooperative surgery as Rescue-treatment for Advanced gastric Cancer in patients Unfit for Surgery (LE-RACUS): protocol for a feasibility study.","authors":"Henrik Maltzman, Masami Omae, Fredrik Klevebro, Francisco Baldaque-Silva, Ioannis Rouvelas","doi":"10.1186/s40814-024-01584-3","DOIUrl":"10.1186/s40814-024-01584-3","url":null,"abstract":"<p><strong>Background: </strong>The standard treatment for advanced gastric cancer without metastasis is gastrectomy in combination with chemotherapy. Some patients cannot tolerate such treatment because of old age or comorbidities. In this study, we want to test the feasibility of Laparoscopic and Endoscopic Cooperative Surgery (LECS) as a less invasive treatment option. In LECS, the tumor margin is marked endoscopically, followed by surgical removal under endoscopic guidance. Currently, LECS is primarily used in Asian countries as a treatment for gastrointestinal stromal cell tumors.</p><p><strong>Methods: </strong>The study will be conducted as a prospective single-center, feasibility trial. The primary objective will be the safety of LECS, defined as Clavien-Dindo score ≥ III. The secondary objectives will be any complications, postoperative bleeding/perforation, operation time, radicality, mortality, hospital stay, and health-related quality of life. The inclusion criteria will be patients with gastric cancer cT2-T4aN0M0, Borrman type 1-2 < 5 cm, or type 3 < 2 cm that the tumor board assesses as not fit for gastrectomy. Exclusion criteria will be Borrman type 4 and lesions in the cardia. The patients will be followed up with an outpatient appointment 30 days after the procedure.</p><p><strong>Discussion: </strong>LECS is a promising treatment option for patients with gastric cancer who cannot tolerate gastrectomy. Compared to gastrectomy, LECS is a less invasive procedure with a documented low complication rate. No previous prospective studies have been conducted to evaluate LECS for advanced gastric cancer.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier: NCT06105515. Registered 23 October 2023. https://clinicaltrials.gov/study/NCT06105515?cond=Gastric%20Cancer&term=NCT06105515&aggFilters=status:not%20rec&rank=1.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"1"},"PeriodicalIF":1.5,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11697475/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142927765","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":"The collaborative working group method for pre-trial knowledge mobilisation: a qualitative evaluation of a structured process for iteratively refining a complex intervention (DAFNEplus).","authors":"J P Breckenridge, R Gossage-Worrall, P Chadwick, N De Zoysa, J Elliott, C Gianfrancesco, K Hamilton, S Heller, J Lawton, D Rankin, S Stanton-Fay, E Coates","doi":"10.1186/s40814-024-01576-3","DOIUrl":"10.1186/s40814-024-01576-3","url":null,"abstract":"<p><strong>Background: </strong>There is a lack of practical guidance about how to effectively mobilise knowledge at the pre-trial stage. Despite increased guidance on developing complex interventions in recent years, much of this focuses on the theory and principles behind high-quality intervention development, rather than the practical aspects of how this should be achieved. This paper shares the findings from an embedded, qualitative evaluation of the Collaborative Working Group (CWG) process, a structured approach we developed to iteratively refine a complex intervention prior to a randomised controlled trial.</p><p><strong>Methods: </strong>The CWG was designed and delivered to support iterative refinements to a complex intervention pre-trial as part of the DAFNEplus research programme, a large intervention development study to refine and pilot a self-management education programme for people with type 1 diabetes. The CWG comprised monthly teleconferences and four strategically timed face-to-face meetings throughout the pre-trial period to support knowledge sharing between the practitioners delivering the pilot intervention and the researchers evaluating it. We conducted an embedded qualitative study to elicit CWG members' experiences and to hear their views of the acceptability, feasibility and effectiveness of the approach. Data were generated through two focus groups with CWG members, four individual interviews with CWG facilitators and documentary analysis of meeting materials.</p><p><strong>Results: </strong>This qualitative evaluation shows that participants generally found the CWG to be an acceptable, feasible and useful approach to supporting complex intervention refinement pre-trial. The qualitative findings highlight five critical elements that shape the success and acceptability of the CWG approach: funnelling knowledge over time, negotiating trust, balancing practicalities, making epistemic compromises and managing power and hierarchy in decision-making. The findings highlight the need to build in adequate time and resources to support trust-building and knowledge sharing throughout each stage in the research process, in addition to the benefits of creating boundary-spanning roles.</p><p><strong>Conclusions: </strong>This paper showcases a practical approach to operationalising collaborative intervention refinement and development pre-trial, with tangible lessons and recommendations for future research teams. The paper adds new insights and practical guidance to the intervention development and knowledge mobilisation fields.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"154"},"PeriodicalIF":1.5,"publicationDate":"2024-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11662412/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872585","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":"PTSD Coach as an early mobile intervention to improve cancer-related anxiety and psychosocial oncology uptake in patients newly diagnosed with head and neck cancer: pilot randomized controlled trial.","authors":"Laurence Ducharme, Chris Lo, Michael Hier, Anthony Zeitouni, Karen Kost, Alex Mlynarek, Michael Antoni, Eric Kuhn, Jason E Owen, Daren Heyland, Robert Platt, Fabienne Fuehrmann, Nader Sadeghi, Zeev Rosberger, Saul Frenkiel, Khalil Sultanem, George Shenouda, Fabio Cury, Melissa Henry","doi":"10.1186/s40814-024-01556-7","DOIUrl":"10.1186/s40814-024-01556-7","url":null,"abstract":"<p><strong>Background: </strong>This pilot study aimed to provide supportive evidence for the feasibility of conducting a full-scale intervention trial with patients newly diagnosed with head and neck cancer (HNC). This included assessing the acceptability and potential usefulness of the PTSD Coach mobile app as an early self-management intervention that gives information about anxiety symptoms, offers self-assessment of symptoms with feedback, tools to self-manage anxiety, and connects to support.</p><p><strong>Methods: </strong>A three-arm randomized controlled trial was conducted. The primary pilot study questions related to feasibility were: (1) can we recruit enough (i.e., n = 60 over 8 months or 8/month) and retain a sufficient proportion (i.e., ≥ 85% at three months post-randomization, having completed the primary outcome) of patients with HNC in all trial arms? (2) Will there be at least a 90% completion rate of PTSD Coach within 3 weeks from randomization? (3) Will at least 85% of the content for each module of PTSD Coach be completed? (4) Will there be at least a 90% completion rate of the attention-control tasks (i.e., 45 min/week over 3 weeks)? (5) What would be the anticipated sample size for a full study? (6) We also explored a signal for intervention effects on 1-, 3-, and 6-month levels of cancer-related anxiety, quality of life, anxiety and depression, self-stigma of seeking help, and professional psycho-oncology service uptake.</p><p><strong>Results: </strong>Participants comprised 39 patients (11 experimental group (EG), 13 attention-control (AC), 15 usual care (UC)), primarily male (82%). Enrolment was lower than expected, with strategies implemented to increase the study's participation rate (i.e., shortening the questionnaire, more relevant AC games, pacing study components, and enlarging eligibility to 4 weeks post-diagnosis instead of 2). Retention rates, intervention completion rates, and completion time were adequate. The intervention was acceptable with all patients (100%) who received PTSD Coach reporting it a positive experience and that they would recommend it to others. When compared to UC, there was a signal for the PTSD Coach group to report lower 3-month cancer-related anxiety (PCL-S; eta squared = 0.013), lower anxiety and depression (HADS; eta squared = 0.015), anxiety (HADS-A; eta squared = 0.028), and higher functional wellbeing (FACT-FW; eta squared = 0.09), based on effect sizes calculated across all three groups. The sample size for a full study was estimated to be 118 to 154 per group.</p><p><strong>Conclusion: </strong>A repeat pilot study with an expanded oncology population is warranted to further investigate feasibility prior to a full Phase III study. PTSD Coach could be a valuable self-management tool as an initial stepped-care approach intervention in patients newly diagnosed with HNC.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT03651570 . Registered June 26, 2018.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"153"},"PeriodicalIF":1.5,"publicationDate":"2024-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11662848/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872503","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":"A co-designed intervention to support people living with achalasia to eat in a social setting: a feasibility study.","authors":"Melika Kalantari, Amelia Hollywood, Rosemary Lim, Majid Hashemi","doi":"10.1186/s40814-024-01574-5","DOIUrl":"10.1186/s40814-024-01574-5","url":null,"abstract":"<p><strong>Background: </strong>Achalasia is a rare oesophageal condition that can affect eating behaviours. This study aimed to evaluate the feasibility of recruitment and assess the acceptability of a co-designed, workbook-based intervention targeting one of the most challenging eating behaviours, which was eating in a social setting.</p><p><strong>Methods: </strong>A mixed-method approach was employed, which involved pre- and post-intervention questionnaires and semi-structured interviews. The Achalasia Action group, a UK-based support group, facilitated participant recruitment. The intervention was a workbook designed collaboratively by the researchers and people living with achalasia, with strategies built on the COM-B model (Capability, Opportunity, Motivation-Behaviour). Outcome measures were based on recruitment and retention rates, the APEASE criteria for usability and acceptability, self-reported changes in eating behaviours, and qualitative feedback from participant interviews.</p><p><strong>Results: </strong>The study aimed to recruit 20 participants, and this target was achieved, resulting in a 100% recruitment rate. However, the post-intervention questionnaires were completed by only 10 participants, indicating a 50% retention rate from baseline. No issues were raised with completing the pre- and post-questionnaires, from completers. The quantitative feedback from participants indicated that they found the workbook activities clear, easy to understand, and complete, with the majority reporting positive experiences. Qualitative feedback on the intervention described enhanced social support and improved symptom management of achalasia in a social setting. Furthermore, the intervention met the APEASE criteria, indicating its usability and acceptability.</p><p><strong>Conclusions: </strong>This study explored the feasibility of recruiting and retaining people living with achalasia in intervention research, highlighting the acceptability of the co-designed intervention to improve social eating experiences. However, with a retention rate of only 50% at follow-up, it is evident that future studies should explore the reason behind this and also consider recruiting a larger baseline sample to ensure the target is achieved. The positive outcomes of the co-designed intervention underscore the importance of user involvement in developing interventions. The intervention demonstrated the potential to support people living with achalasia in eating in a social setting. The co-designed intervention has significant practical implications by providing healthcare professionals and support groups with a feasible, potentially effective method to enhance the social eating experience of people living with achalasia, potentially improving their overall quality of life.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"152"},"PeriodicalIF":1.5,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11657995/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142865002","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":"A protocol for a feasibility study of Cognitive Bias Modification training (IVY) countering fatigue in people with breast cancer.","authors":"Jody A Geerts, Ester J M Siemerink, Falko F Sniehotta, Lucie J M Loman, Christina Bode, Marcel E Pieterse","doi":"10.1186/s40814-024-01571-8","DOIUrl":"10.1186/s40814-024-01571-8","url":null,"abstract":"<p><strong>Background: </strong>Cancer-related fatigue (CRF) is the most prevalent, distressing, and quality of life disturbing symptom during and after cancer treatment for many cancer types including breast cancer. The experience and burden of this symptom can induce a cognitive bias towards fatigue or a fatigue-related self-image, which can further increase the fatigue symptoms and related behaviour. For this, a Cognitive Bias Modification (CBM) eHealth app (IVY) has been developed. The app aims to counter the fatigue-related self-image and to modify it towards vitality, which might translate to less experienced fatigue and more experienced vitality. This study aims to evaluate the feasibility of the IVY CBM training and the research design of a wait-list control trial. If feasibility is judged sufficient, the effectiveness of the CBM app will also be analyzed on (1) underlying mechanisms (cognitive fatigue bias), (2) symptom fatigue (self-reported fatigue and vitality), and (3) related behaviours (avoidance and all-or-nothing behaviour).</p><p><strong>Methods: </strong>This feasibility study addresses individuals being treated for breast cancer receiving (neo)adjuvant treatment or metastatic care. The number of target participants is 120 (60 (neo)adjuvant, and 60 metastatic) patients. Both groups will be randomized with 30 people in the IVY treatment group and 30 people in the delayed treatment control group. All participants will receive the training via the IVY app, in which participants categorize words related to vitality with words related to 'I' and words related to fatigue with words related to 'other'. If feasibility is judged sufficient, the effects of the training will be explored on 3 levels: (1) self-identity bias, which will be measured with a short computer task based on the Implicit Association Test (IAT), (2) avoidance and all-or-nothing behaviour, and (3) fatigue and vitality levels, which will all be measured with questionnaires.</p><p><strong>Discussion: </strong>This study aims to evaluate the feasibility of a larger-scale multi-centre Randomized Controlled Trial (RCT) to investigate a novel eHealth application and, if possible, to give indications on the effectiveness of this intervention to counter fatigue in individuals with breast cancer. Using the IVY CBM app requires very little effort, both in time and cognitive load, which could be especially beneficial for fatigue symptoms.</p><p><strong>Trial registration: </strong>Registered at the Open Science Framework (OSF; https://osf.io/e85g7/ ) on October 20, 2023.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"151"},"PeriodicalIF":1.5,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11654401/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142854553","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":"Development of a comprehensive clinical assessment protocol for low back and hip pain in powerlifters: a feasibility study.","authors":"Patrik Olofsson, Ulrika Aasa, Lars Berglund","doi":"10.1186/s40814-024-01579-0","DOIUrl":"10.1186/s40814-024-01579-0","url":null,"abstract":"<p><strong>Background: </strong>Low back and hip pain problems are frequent in powerlifting. There is a lack of information on the specific pain phenotypes and specific impairments in body function associated with these pain problems, as well as how to reach a clinical diagnosis relevant for powerlifters' pain problems. Therefore, the aim was to develop a comprehensive clinical assessment protocol for pain and function in powerlifters with low back and/or hip pain and evaluate its feasibility for use in further epidemiological or clinical studies of powerlifters.</p><p><strong>Methods: </strong>The study was conducted in two phases. In phase one, the protocol was developed according to literature regarding musculoskeletal assessment and sports injuries, and in phase two, feasibility was evaluated. Eight powerlifters with low back/hip pain were included in phase two. Four of them were examined independently by two physical therapists, and the other four were examined by one of the physical therapists. The time spent on the examination, whether the physical therapists could reach a clinical diagnosis without adding items to the protocol, and whether the two physical therapists were consistent in terms of the clinical diagnosis, were evaluated.</p><p><strong>Results: </strong>The protocol was developed including subjective examination, physical examination, and a clinical diagnosis based mainly on signs and symptoms of associated neurophysiological pain mechanisms and the specific impairments in body functions associated with the powerlifter's pain problem. The protocol met the feasibility criteria. The examination lasted approximately 1 h, no items needed to be added, and both physical therapists were able to make a consistent clinical diagnosis. Visual observation and alteration of movement strategy of the squat/deadlift were thought to be crucial for assessing the powerlifters' pain problem.</p><p><strong>Conclusions: </strong>This is the first comprehensive clinical assessment protocol developed to describe powerlifters' pain problems/injuries with a clinical diagnosis based on the dominating neurophysiological pain mechanism and impairments in body functions. However, before use in larger studies, it is recommended that the protocol be further evaluated by a larger number of physical therapists and powerlifters to evaluate its reliability and whether the content of the protocol should be further expanded.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"150"},"PeriodicalIF":1.5,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11636030/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142818960","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":"Efficacy and experience of system constellations in virtual reality (VR): study protocol for a randomized controlled feasibility study.","authors":"Tobias van Bebber, Eik-Henning Tappe, Thomas Druyen, Heiko Kleve, Tom Rüsen, Christina Hunger-Schoppe","doi":"10.1186/s40814-024-01513-4","DOIUrl":"10.1186/s40814-024-01513-4","url":null,"abstract":"<p><strong>Background: </strong>Though evidence-based research about system constellations (SCs) appears marginal, it is applied in many psychiatric, psychological, and psychotherapeutic institutions as well as in different contexts of organizational counseling. To date, only one randomized controlled trial (RCT) has been conducted to assess the short- to long-term efficacy of SCs, which entail clients meeting at the same location in person. This study is to investigate the feasibility of a RCT investigating SCs in virtual reality (VR), and to calculate the number of clients needed for a confirmatory RCT.</p><p><strong>Design: </strong>We will perform a prospective, monocentric, parallel-group, feasibility RCT with subsequent intervention. A total of 128 clients of 3-day group-based SC-VR seminars will be randomized to either the intervention group (IG; n = 64) or wait-list group (WLG; n = 64), which receives SCs in VR after 4 months. Feasibility and acceptability of the (1) research methodology and (2) intervention as well as the (3) estimation of effect sizes will be assessed using qualitative and quantitative data. Based on the model of a general mental health, the proposed primary outcome includes the SC-VR adherence, and the proposed secondary outcomes refer to psychological functioning (OQ-45.2), social system functioning (EXIS), psychological distress (FEP-2), motivational incongruence (INK-SF), and goal attainment (GAS). We plan to investigate the short-term efficacy at 2-week and 4-month follow-up within the RCT design (n = 128), and mid-term efficacy at 8- and 12-month follow-up for the intervention group (n = 64).</p><p><strong>Discussion: </strong>The study is expected to be the first study on the feasibility of SC-VR. We will reflect on successfully implemented study procedures, and we will provide recommendations for changes considering the design, rationale, analyses, and interpretation of the study results where they became necessary. The discussion will conclude with an evaluation whether a confirmatory RCT on SC-VR is worth the investment of future resources, including the calculated number of clients needed based on the efficacy trends derived from this feasibility study.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: ID = N CT05557890; date of registration: September 23, 2022; https://clinicaltrials.gov/ct2/show/NCT05557890 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"149"},"PeriodicalIF":1.5,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11636043/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142818961","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}