scholarly journals Development and Feasibility of a Web-based Decision Aid for Patients with Ulcerative Colitis: a Qualitative Pilot Study (Preprint)

2019 ◽  
Author(s):  
Andrew H Kim ◽  
Afaf Girgis ◽  
Peter De Cruz ◽  
Corey A Siegel ◽  
Neda Karimi ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Trial ◽  
Pilot Study ◽  
Usual Care ◽  
Treatment Options ◽  
Treatment Decisions ◽  
Participatory Approach ◽  
Clinical Trial Registry ◽  
Web Based ◽  
Trade Offs

BACKGROUND Shared decision making (SDM) is becoming an important part of ulcerative colitis (UC) management because of increasing complexity in available treatment choices and their trade-offs. Use of decision aids (DA) may be effective in increasing patients’ participation in their management but their uptake has been limited due to high attrition rates, and lack of a participatory approach to their design and implementation. OBJECTIVE The primary aim of this study was to explore the perspectives of Australian patients and their clinicians regarding the feasibility and acceptability of myAID, a web-based DA, in informing treatment decisions in UC. The secondary aim was to use the findings of this pilot study to inform the design of a cluster randomized clinical trial (CRCT) to assess the efficacy of the DA compared with usual care. METHODS myAID, a DA was designed and developed using a participatory approach by a multidisciplinary team of clinicians, patients and non-medical volunteers. A qualitative pilot study to evaluate the DA, involving UC patients facing new treatment decisions and IBD clinicians, was undertaken. RESULTS Eleven UC patients and 15 clinicians provided feedback on myAID. Themes explored included: (1) Acceptability and usability of myAID - (a) myAID was found to be acceptable by the majority of clinicians as a tool to facilitate SDM; (b) Uptake was thought to vary depending on clinicians’ approaches to patient education and practice; (c) Potential to overcome time-restrictions associated with outpatient clinics was identified; (d) Presentation of unbiased information enabling patients to digest information at their own pace was noted; (e) Potential to provoke anxiety among patients with a new diagnosis or mild disease was raised; (2) Perceived role and usefulness of myAID - (a) Discordance was observed between patients who prioritized voicing preferences and clinicians who prioritized treatment adherence; (b) myAID facilitated early discussion of medical versus surgical treatment options; (3) Target population and timing of use - Greatest benefit was perceived at the time of initiating or changing treatment and following commencement of immunosuppressive therapy and; (4) Potential concerns and areas for improvement – Some perceived that use of myAID (a) May precipitate anxiety by increasing decisional conflict and impact the therapeutic relationship between patient and the clinician; and (b) May increase resource requirements. CONCLUSIONS These preliminary findings suggest that patients and clinicians consider myAID a feasible and acceptable tool to facilitate SDM for UC management. These pilot data have informed a participatory approach to the design of a CRCT which will evaluate myAID’s clinical efficacy compared with usual care. CLINICALTRIAL Australian New Zealand Clinical Trial Registry (ACTRN12617001246370).

scholarly journals Creatine Supplementation for Patients with Inflammatory Bowl Diseases: A Scientific Rationale for a Clinical Trial

Nutrients ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 1429
Author(s):  
Theo Wallimann ◽  
Caroline H. T. Hall ◽  
Sean P. Colgan ◽  
Louise E. Glover
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Trial ◽  
Crohn’S Disease ◽  
Pilot Study ◽  
Crohn's Disease ◽  
Single Case ◽  
Initial Period ◽  
Creatine Supplementation

Based on theoretical considerations, experimental data with cells in vitro, animal studies in vivo, as well as a single case pilot study with one colitis patient, a consolidated hypothesis can be put forward, stating that “oral supplementation with creatine monohydrate (Cr), a pleiotropic cellular energy precursor, is likely to be effective in inducing a favorable response and/or remission in patients with inflammatory bowel diseases (IBD), like ulcerative colitis and/or Crohn’s disease”. A current pilot clinical trial that incorporates the use of oral Cr at a dose of 2 × 7 g per day, over an initial period of 2 months in conjunction with ongoing therapies (NCT02463305) will be informative for the proposed larger, more long-term Cr supplementation study of 2 × 3–5 g of Cr per day for a time of 3–6 months. This strategy should be insightful to the potential for Cr in reducing or alleviating the symptoms of IBD. Supplementation with chemically pure Cr, a natural nutritional supplement, is well tolerated not only by healthy subjects, but also by patients with diverse neuromuscular diseases. If the outcome of such a clinical pilot study with Cr as monotherapy or in conjunction with metformin were positive, oral Cr supplementation could then be used in the future as potentially useful adjuvant therapeutic intervention for patients with IBD, preferably together with standard medication used for treating patients with chronic ulcerative colitis and/or Crohn’s disease.

scholarly journals Individually tailored self-management app-based intervention (selfBACK) versus a self-management web-based intervention (e-Help) or usual care in people with low back and neck pain referred to secondary care: protocol for a multiarm randomised clinical trial

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e047921
Author(s):  
Anna Marcuzzi ◽  
Kerstin Bach ◽  
Anne Lovise Nordstoga ◽  
Gro Falkener Bertheussen ◽  
Ilya Ashikhmin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Neck Pain ◽  
Usual Care ◽  
Secondary Care ◽  
Self Management ◽  
Low Back ◽  
Musculoskeletal Health ◽  
Web Based ◽  
Management Intervention ◽  
Management Interventions

IntroductionLow back pain (LBP) and neck pain (NP) are common and costly conditions. Self-management is a key element in the care of persistent LBP and NP. Artificial intelligence can be used to support and tailor self-management interventions, but their effectiveness needs to be ascertained. The aims of this trial are (1) to evaluate the effectiveness of an individually tailored app-based self-management intervention (selfBACK) adjunct to usual care in people with LBP and/or NP in secondary care compared with usual care only, and (2) to compare the effectiveness of selfBACK with a web-based self-management intervention without individual tailoring (e-Help).Methods and analysisThis is a randomised, assessor-blind clinical trial with three parallel arms: (1) selfBACK app adjunct to usual care; (2) e-Help website adjunct to usual care and (3) usual care only. Patients referred to St Olavs Hospital, Trondheim (Norway) with LBP and/or NP and accepted for assessment/treatment at the multidisciplinary outpatient clinic for back or neck rehabilitation are invited to the study. Eligible and consenting participants are randomised to one of the three arms with equal allocation ratio. We aim to include 279 participants (93 in each arm). Outcome variables are assessed at baseline (before randomisation) and at 6-week, 3-month and 6-month follow-up. The primary outcome is musculoskeletal health measured by the Musculoskeletal Health Questionnaire at 3 months. A mixed-methods process evaluation will document patients’ and clinicians’ experiences with the interventions. A health economic evaluation will estimate the cost-effectiveness of both interventions’ adjunct to usual care.Ethics and disseminationThe trial is approved by the Regional Committee for Medical and Health Research Ethics in Central Norway (Ref. 2019/64084). The results of the trial will be published in peer-review journals and presentations at national and international conferences relevant to this topic.Trial registration numberNCT04463043.

MON-PP058: Randomised Clinical Trial: Casein Glycomacropeptide for Active Distal Ulcerative Colitis – A Pilot Study

2015 ◽  
Vol 34 ◽  
pp. S149 ◽  
Author(s):  
P.G. Wernlund ◽  
C.L. Hvas ◽  
L.A. Christensen ◽  
J.F. Dahlerup ◽  
M.B. Rasch ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Trial ◽  
Pilot Study ◽  
Randomised Clinical Trial ◽  
Distal Ulcerative Colitis

scholarly journals Use of an Unguided, Web-Based Distress Self-Management Program After Breast Cancer Diagnosis: Sub-Analysis of CaringGuidance Pilot Study (Preprint)

2020 ◽  
Author(s):  
Robin M Lally ◽  
Kevin Kupzyk ◽  
Steve Gallo ◽  
Donna Berry
Keyword(s):  
Breast Cancer ◽  
Pilot Study ◽  
Usual Care ◽  
Cancer Diagnosis ◽  
Intervention Group ◽  
Breast Cancer Diagnosis ◽  
Management Program ◽  
Activity Level ◽  
Self Management ◽  
Web Based

BACKGROUND Unguided, web-based psychoeducational interventions are gaining interest as a way to reach patients while reducing pressure on clinical resources. However, there has been little research on how patients with cancer use these interventions. OBJECTIVE The objective of this analysis was to evaluate how women newly diagnosed with breast cancer used the unguided web-based, psychoeducational distress self-management program CaringGuidance After Breast Cancer Diagnosis while enrolled in a pilot feasibility study. METHODS Women with stage 0 to II breast cancer diagnosed within the prior three months were recruited from clinics primarily in the Northeastern United States for participation in a 12-week pilot study of CaringGuidance plus usual care versus usual care alone. Usage prompts included sets of emails sent weekly for 12 weeks; standardized congratulatory emails after every two hours of program use, and informative emails for each cognitive-behavioral exercise. Individual user activity on the site was automatically tracked by an analytics system and recorded directly in the CaringGuidance database. RESULTS Complete usage data were available for 54 subjects. Ninety-eight percent of the intervention group logged into CaringGuidance independently at least once. Thirty-eight (70%) logged in during all three months, 15 (28%) were intermittent users, and one (2%) was a non-user. Users (n=53) averaged 15.6 (SD 9.85) logins. Mean logins were greatest in month 1 (7.26, SD 4.02) and declined in months 2 (4.32, SD 3.66) and month 3 (4.02, SD 3.82). Eleven (21%) used CaringGuidance with both the frequency and activity level intended at study outset, 9 (17%) exceeded intended frequency and activity (high-high users), and 10 (19%) were below expected usage on both login frequency and activity (low-low users). Low-low users and high-high users differed significantly (<i>P</i>&lt;.001) in the total number of views and unique views of all program components. Change in depressive symptoms and the number of sessions (r=.351) and logins (r=.348) between study months 1 and 2 were significantly correlated (<i>P</i>=.018, .019). Higher baseline distress was associated with more unique views of program resources (r=.281, <i>P</i>=.043). Change in intrusive/avoidant thoughts from baseline to month 3, and the number of users’ unique exercise views were negatively correlated (r=–.319, <i>P</i>=.035) so that more unique exercise views, equated with greater decline in intrusive/avoidant thoughts from baseline to month 3. CONCLUSIONS These findings favor the hypothesis that the key ingredient is not the amount of program use, but each user’s self-selected activity within the program. More research is needed on the ideal ways to maintain use, and capture and define engagement and enactment of behaviors by people with cancer accessing unguided, self-management web-based programs.

scholarly journals A Web-Based Decision Aid (myAID) to Enhance Quality of Life, Empowerment, Decision Making, and Disease Control for Patients With Ulcerative Colitis: Protocol for a Cluster Randomized Controlled Trial

10.2196/15994 ◽  
2020 ◽  
Vol 9 (7) ◽  
pp. e15994
Author(s):  
Andrew H Kim ◽  
Afaf Girgis ◽  
Neda Karimi ◽  
Alexandra J Sechi ◽  
Joseph Descallar ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ulcerative Colitis ◽  
Decision Making ◽  
Decision Aid ◽  
Controlled Trial ◽  
Treatment Decisions ◽  
Web Based ◽  
Randomized Controlled ◽  
Cluster Randomized

Background Patients with ulcerative colitis (UC) often face complex treatment decisions. Although shared decision making (SDM) is considered important, tools to facilitate this are currently lacking for UC. A recent pilot study of a novel Web-based decision aid (DA), my Actively Informed Decision (myAID), has suggested its acceptability and feasibility for informing treatment decisions and facilitating SDM in clinical practice. Objective This paper describes the study protocol of the myAID study to assess the clinical impact of systematic implementation of myAID in routine UC management. Methods The myAID study is a multicenter, cluster randomized controlled trial (CRCT) involving 22 Australian sites that will assess the clinical efficacy of routine use of myAID (intervention) against usual care without access to myAID (control) for UC patients. Participating sites (clusters) will be randomly allocated in a 1:1 ratio between the 2 arms. Patients making a new treatment decision beyond 5-aminosalicylate agents will be eligible to participate. Patients allocated to the intervention arm will view myAID at the time of recruitment and have free access to it throughout the study period. The effect of the myAID intervention will be assessed using the results of serial Web-based questionnaires and fecal calprotectin at baseline, 2 months, 6 months, and 12 months. A Web-based questionnaire within 2-4 weeks of referral will determine early change in quality of decision making and anxiety (both arms) and intervention acceptability (intervention arm only). Results Study recruitment and funding began in October 2016, and recruitment will continue through 2020, for a minimum of 300 study participants at baseline at the current projection. The primary outcome will be health-related quality of life (Assessment of Quality of Life-8D), and secondary outcomes will include patient empowerment, quality of decision making, anxiety, work productivity and activity impairment, and disease activity. In addition, we aim to determine the predictors of UC treatment decisions and outcomes and the cost-effectiveness of implementing myAID in routine practice. Feedback obtained about myAID will be used to determine areas for improvement and barriers to its implementation. Completion of data collection and publication of study results are anticipated in 2021. Conclusions myAID is a novel Web-based DA designed to facilitate SDM in UC management. The results of this CRCT will contribute new evidence to the literature in comparing outcomes between patients who routinely access such decision support intervention versus those who do not, across multiple large inflammatory bowel disease centers as well as community-based private practices in Australia. Trial Registration Australian New Zealand Clinical Trial Registry ACTRN12617001246370 http://anzctr.org.au/Trial/ Registration/TrialReview.aspx?ACTRN=12617001246370 International Registered Report Identifier (IRRID) DERR1-10.2196/15994

scholarly journals Advance of Novel Coronavirus Registration Clinical Trial

2020 ◽  
Author(s):  
Gao Song ◽  
Meng Qun Cheng ◽  
Xian Wen Wei
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Treatment Options ◽  
Descriptive Analysis ◽  
Clinical Trial Registry ◽  
Chi Square ◽  
Plasma Therapy ◽  
Study Duration ◽  
Design Characteristics ◽  
Novel Coronavirus

AbstractBackgroundTo analyze the characteristics and heterogeneity of clinical trials of Novel Coronavirus(COVID-19) registered in the China Clinical Trial Registry (ChiCTR), and provide data bases and information references for clinical treatmentMethodsStatistics of COVID-19 clinical trials registered with ChiCTR as of February 24, 2020 were collected. Descriptive analysis of registration characteristics. The chi-square test is used to compare statistical differences between different study types, intervention methods, study stage, and Primary sponsor.Results232 COVID-19 studies registered at the ChiCTR were collected. The overall number of COVID-19 registrations was increased. Hubei Province, China has the largest number of registrations. There were significant differences between the number of participants(P=0.000), study duration(P=0.008), study assignment(P=0.000), and blind method(P=0.000) for different study types. Significant differences could be seen in the dimensions of multicenter study(P=0.022), of participants numbe(P=0.000), study duration(P=0.000) and study assignment(P=0.001) for the four intervention methods. There were significant differences in study assignment(P=0.043) between the early and late studies. CMT drugs with high research frequency are chloroquine, lopinavir / ritonavir, and I-IFN; BI was Cell therapy, plasma therapy, Thymosin, and M/P-AB.ConclusionsDifferent study design characteristics have led to significant differences in some aspects of the COVID-19 clinical trial. Timely summary analysis can provide more treatment options and evidence for clinical practice.

scholarly journals A Patient-Centred Approach to Understanding the Trade-Offs Associated with Treatment Decision Making in Hematological Cancers with Short Life Expectancy

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 5899-5899
Author(s):  
Chloe Johnson ◽  
Timothy J Bell ◽  
Kate Sully ◽  
Verna L Welch ◽  
Francois Peloquin ◽  
...  
Keyword(s):  
Patient Experience ◽  
Treatment Options ◽  
Treatment Decision ◽  
Treatment Decisions ◽  
Patient Perspectives ◽  
Employment Equity ◽  
Treatment Decision Making ◽  
Trade Offs ◽  
Hematological Cancers ◽  
Equity Ownership

Abstract INTRODUCTION: Patient experience data provides an opportunity to explore patient's perspectives on current and potential treatments. Gaining patient narratives on the expectation, tolerance and attitudes towards treatments can enhance clinical management and inform discussions with payers and regulatory agencies. Patient experience data is particularly beneficial in conditions where there is no clear, prescribed treatment pathway as it can contextualize joint treatment decisions made by patients and their treating physicians. Life expectancy among elderly patients with hematogical cancers such as acute myeloid leukemia (AML) is short. Patients with these conditions may be eligible for intensive chemotherapy (IC) or may face a decision between non-intensive chemotherapy (NIC) or palliative care. Further, eligible patients may not wish to undergo the taxing treatment regimens associated with IC. A targeted literature review was conducted to understand the trade-offs associated with treatment decision making and to gain patient perspectives on the value of extended overall survival (OS) in hematological cancers. METHODS: Searches of computerized bibliographic databases including PubMed (Medline), EMBASE and PsycINFO were conducted using the OVID platform. Searches were conducted using a combination of keywords and Medical Subject Headings (MeSH) terms. To be selected for review, articles must have contained keywords in the title and/or abstract and include information regarding patient experience or perspectives. Articles focussed on children (<18 years) and those not available in English were not included. RESULTS: A total of 26 articles were selected for full text review (12 AML-specific, 13 other hematological cancers and one article with findings relevant to both populations). Most articles selected for inclusion were qualitative research studies (n=23), providing rich detail regarding the patient perspective. AML patients discussed the lack of a clear, defined treatment pathway, unlike other cancers where there is a prescribed course of action. These patients described feeling trapped between two undesirable treatment options (IC versus palliative care) and described this treatment decision as "do or die". Similarly, in other hematological cancers patients reported choosing IC to extend their life, while acknowledging that the treatment itself can be distressing. It appeared that the idea of living longer dominated this trade-off. Some patients expressed regret in choosing IC after experiencing the associated side effects. These findings suggest that patients may not fully understand the treatment options available to them, which highlights the importance of the patient-clinician relationship. Findings from studies also highlighted quality of life as an important consideration for patients in addition to the quantity or length of life. Specifically, patients emphasized their need to maintain a 'normal life' following their diagnosis and to be able to engage in their hobbies and daily activities. There is a paucity of research into important life milestones for AML patients. However, patients and caregivers with other hematological cancers described their desire to be alive for family occasions, such as births or weddings, as well as a sense of appreciation and gratitude for the time remaining with their loved one. This was particularly evident for those patients who were parents of younger children, who felt unprepared for the untimely passing of their kin. CONCLUSIONS: Heterogeneity in the presentation, functional status and presence of comorbidities among patients with AML and other hematological cancers presents unique challenges for treatment. Nevertheless, understanding of aetiology and epidemiology of these conditions continues to evolve. In response, medical product development/evaluation, policy and treatment decisions in clinical practice need to reflect patient perspectives of treatment in terms of expectations, goals, experiences and preferences to ensure selection of the most appropriate treatment for a given individual. Existing evidence provides some insight as to factors that are important to patients and may influence treatment decisions. However, further research to understand patient perspectives, particularly among those who may not be eligible or willing to receive IC, is required. Disclosures Johnson: Adelphi Values Ltd: Consultancy. Bell:Pfizer: Employment, Equity Ownership. Sully:Adelphi Values Ltd: Employment; Amgen: Consultancy. Welch:Pfizer: Employment, Equity Ownership. Peloquin:Pfizer: Employment, Equity Ownership. Gater:Adelphi Values Ltd: Consultancy.

scholarly journals Use of an Unguided, Web-Based Distress Self-Management Program After Breast Cancer Diagnosis: Sub-Analysis of CaringGuidance Pilot Study

10.2196/19734 ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. e19734 ◽  
Author(s):  
Robin M Lally ◽  
Kevin Kupzyk ◽  
Steve Gallo ◽  
Donna Berry
Keyword(s):  
Breast Cancer ◽  
Pilot Study ◽  
Usual Care ◽  
Cancer Diagnosis ◽  
Intervention Group ◽  
Breast Cancer Diagnosis ◽  
Management Program ◽  
Activity Level ◽  
Self Management ◽  
Web Based

Background Unguided, web-based psychoeducational interventions are gaining interest as a way to reach patients while reducing pressure on clinical resources. However, there has been little research on how patients with cancer use these interventions. Objective The objective of this analysis was to evaluate how women newly diagnosed with breast cancer used the unguided web-based, psychoeducational distress self-management program CaringGuidance After Breast Cancer Diagnosis while enrolled in a pilot feasibility study. Methods Women with stage 0 to II breast cancer diagnosed within the prior three months were recruited from clinics primarily in the Northeastern United States for participation in a 12-week pilot study of CaringGuidance plus usual care versus usual care alone. Usage prompts included sets of emails sent weekly for 12 weeks; standardized congratulatory emails after every two hours of program use, and informative emails for each cognitive-behavioral exercise. Individual user activity on the site was automatically tracked by an analytics system and recorded directly in the CaringGuidance database. Results Complete usage data were available for 54 subjects. Ninety-eight percent of the intervention group logged into CaringGuidance independently at least once. Thirty-eight (70%) logged in during all three months, 15 (28%) were intermittent users, and one (2%) was a non-user. Users (n=53) averaged 15.6 (SD 9.85) logins. Mean logins were greatest in month 1 (7.26, SD 4.02) and declined in months 2 (4.32, SD 3.66) and month 3 (4.02, SD 3.82). Eleven (21%) used CaringGuidance with both the frequency and activity level intended at study outset, 9 (17%) exceeded intended frequency and activity (high-high users), and 10 (19%) were below expected usage on both login frequency and activity (low-low users). Low-low users and high-high users differed significantly (P<.001) in the total number of views and unique views of all program components. Change in depressive symptoms and the number of sessions (r=.351) and logins (r=.348) between study months 1 and 2 were significantly correlated (P=.018, .019). Higher baseline distress was associated with more unique views of program resources (r=.281, P=.043). Change in intrusive/avoidant thoughts from baseline to month 3, and the number of users’ unique exercise views were negatively correlated (r=–.319, P=.035) so that more unique exercise views, equated with greater decline in intrusive/avoidant thoughts from baseline to month 3. Conclusions These findings favor the hypothesis that the key ingredient is not the amount of program use, but each user’s self-selected activity within the program. More research is needed on the ideal ways to maintain use, and capture and define engagement and enactment of behaviors by people with cancer accessing unguided, self-management web-based programs.

Feasibility of integrating the Outcomes4Me smartphone navigation application into the care of breast cancer patients (FIONA).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1570-1570
Author(s):  
Steven J. Isakoff ◽  
Maya Said ◽  
Agnes H. Kwak ◽  
Eva Glieberman ◽  
Amanda Stroiney ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Pilot Study ◽  
Patient Engagement ◽  
Medical Center ◽  
Treatment Options ◽  
Academic Medical Center ◽  
Patient Reported ◽  
Clinical Trial Information

1570 Background: Patients diagnosed with breast cancer (BC) face complex decisions about their care and many studies have shown that improved patient engagement results in increased satisfaction and better outcomes. Patient engagement includes education, treatment option selection, symptom tracking and reporting, and clinical trial opportunities. We conducted a pilot study to determine the feasibility of introducing the Outcomes4Me patient engagement app into the standard of care experience of BC patients. Methods: This was a pilot study (NCT04262518) conducted at an academic medical center. Eligible patients had any subtype of stage 1-4 BC and were on any type of chemo-, hormonal-, targeted-, or radiation-therapy for BC during the study period. Participants downloaded the app on their smartphone and their app usage was evaluated. Surveys were administered at baseline and end of study. Clinicians caring for patients using the app were surveyed at the end of the study. The primary endpoint was feasibility, defined as at least 40% of patients engaging with the app at least 3 times over the 12-week study period. Additional endpoints included usability, satisfaction, correlation of patient reported data with the EHR, clinical trial matching, and patient experience. Results: Between June 2020 and December 2020, 107 patients enrolled; results are reported for 90 patients with complete data as of 1/24/21. Baseline demographics: median age 53 (range: 27-77); 90% White, 4% Black, 3% Asian; 66% had hormone positive/HER2-, 20% HER2+, and 13% triple negative BC; 31% had stage 4 disease. At study entry, 93% had never used an app to help with their disease or treatment options. Over the 12 week study period, 58% of patients engaged with the app at least 3 times, meeting the primary feasibility endpoint. Patients engaged with the app on average 5.5 days (range: 0-40) with 20% engaging on more than 10 days during the study. The mean System Usability Score was 71 (median = 76) and was similar across age groups. The 5 app features deemed most (‘somewhat’ or ‘very’) helpful were: background about their BC (76%), information about treatment options (74%), newsfeed about their BC (70%), symptom tracking (65%), and clinical trial information (65%). 53% said that the app helped them keep track of symptoms and 33% said they are more likely to explore or enroll in a clinical trial after using the app. Conclusions: Integration of the Outcomes4Me app into the care management of BC patients is feasible with acceptable usability. Our results suggest that use of a patient smartphone app may be helpful for many aspects of patient education and engagement for patients with BC. The results also suggest that this type of intervention can help patients better track their symptoms and make them aware of clinical trials, potentially facilitating the management of side effects and accelerating clinical trials recruitment. Clinical trial information: NCT04262518.

Variations in patient-reported outcome (PRO) collection and reporting in novel FDA approved anticancer therapies.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18202-e18202
Author(s):  
Surbhi Singhal ◽  
Evan Thomas Hall ◽  
Brooke Peterson Gabster ◽  
James Dickerson ◽  
Lidia Schapira
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Treatment ◽  
Treatment Options ◽  
Patient Reported Outcome ◽  
Cancer Therapies ◽  
Clinical Trial Registry ◽  
Fda Approval ◽  
Patient Reported ◽  
Anti Cancer

e18202 Background: Patient-reported outcomes (PROs) are increasingly valued as a key tool in patient-focused treatment decisions. However, a lack of standardization leads to significant variability in PRO collection and reporting in ground-breaking clinical trials of novel agents. We sought to characterize the mechanisms of assessment and variability by which PROs are reported for newly approved anti-cancer therapies. Methods: We reviewed the U.S. Food and Drug Administration (FDA) approvals between 2011 and 2017 for anti-cancer new molecular entities (NMEs) and new biologic approvals (BLAs). For each therapy, the pivotal clinical trial leading to FDA approval was identified using the national clinical trial (NCT) number and assessed for inclusion of PROs. A separate PubMed search was conducted to evaluate for PRO publication distinct from the original trial based on national clinical trial registry number. Results: From 2011 to 2017, the FDA approved 66 NMEs/BLAs based on 74 clinical trials for cancer treatment. Of the 74 clinical trial publications, 21 (28%) of the trials published PRO data in their original clinical publication, 18 (24%) published a separate PRO analysis, and 35 (47%) did not publish PRO data in either format. Among the 32 clinical trials (43%) that listed PROs as pre-specified outcomes, 72% published PROs (23/32). The separate PRO analyses (N = 18) were published considerably later following FDA approval (mean 605 days) than the original clinical trials (mean 20 days, N = 74, P < 0.001). Conclusions: As cancer treatment options expand, therapy decisions become increasingly nuanced. PROs assist decision-making by providing detailed information on important aspects of quality of life and tolerability. Our research has identified a significant lag in the publication of companion studies of PRO data associated with pivotal clinical trials, representing a meaningful gap in information critical to patients and oncologists in the process of making informed decisions.

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