A nurse-led intervention in patients with newly diagnosed cancer and Type 2 diabetes: A pilot randomized controlled trial feasibility study.
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ABSTRACT: Background
Undiagnosed Type 2 diabetes (T2D) has been associated with advanced stage cancer at diagnosis, higher mortality, and lower long-term all-cause survival. This was a RCT pilot study to examine the feasibility of a nurse-led T2D intervention for adults with newly diagnosed cancer (≤3 months), and T2D, undiagnosed or untreated with medication, conducted at an outpatient oncology clinic affiliated with a large academic institution.Methods
Participants needed to meet the eligibility criteria including a HbA1c level between 6.5% and 9.9%. Randomization was 1:1 to a 3-month intervention that consisted of nursing-led diabetes education and immediate initiation of metformin versus referral to primary care for usual care (control).Results
Three hundred and seventy nine patients were screened using EHR, 55 agreed to participate, and 3 had eligible HbA1c levels and were randomized in the study. Primary reasons for study exclusion included life expectancy ≤2 years (16.9%), current use or inability to tolerate metformin (14.8%), and abnormal labs that contraindicated metformin use (13.9%).Conclusion
This study was not feasible due to recruitment inefficiencies, but acceptable to all who qualified.
SUBMITTER: Scarton L
PROVIDER: S-EPMC10278510 | biostudies-literature | 2023 Jun
REPOSITORIES: biostudies-literature
Publications
A nurse-led intervention in patients with newly diagnosed cancer and Type 2 diabetes: A pilot randomized controlled trial feasibility study.
Scarton Lisa L Nelson Tarah T Jo Ara A O'Neal LaToya J LJ Yao Yingwei Y Huggins Shavondra S Legaspi Anatolia B AB McClaren Mariah J MJ Cabassa Jake S JS Burgos Melendez Joan M JM Munoz-Pena Juan M JM Markham Merry J MJ Murphy Martina C MC Chatzkel Jonathan A JA Rogers Sherise S George Thomas J TJ
Cancer medicine 20230522 11
<h4>Background</h4>Undiagnosed Type 2 diabetes (T2D) has been associated with advanced stage cancer at diagnosis, higher mortality, and lower long-term all-cause survival. This was a RCT pilot study to examine the feasibility of a nurse-led T2D intervention for adults with newly diagnosed cancer (≤3 months), and T2D, undiagnosed or untreated with medication, conducted at an outpatient oncology clinic affiliated with a large academic institution.<h4>Methods</h4>Participants needed to meet the eli ...[more]
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Project description:IntroductionSmoking cessation is an essential, but often overlooked aspect of diabetes management. Despite the need for tailored smoking cessation support for individuals with diabetes, evidence of effective interventions for this cohort is limited. Additionally, individuals with diabetes do not easily adopt such interventions, resulting in low uptake and abstinence rates. This protocol describes a study that aims to assess the feasibility and acceptability of a unique smoking cessation intervention, based on the best evidence, theory and the needs of individuals with diabetes, among patients and service providers, the diabetes nurse educators.Methods and analysisThis is an open-label pragmatic randomised controlled trial. Between 80 and 100 individuals with type 1 or type 2 diabetes who smoke will be recruited from the diabetes outpatients at the main acute public hospital in Malta, starting in August 2023. Participants will be randomly assigned (1:1 ratio) to the intervention or control arm for 12 weeks. The experimental intervention will consist of three to four smoking cessation behavioural support sessions based on the 5As (Ask, Advise, Assess, Assist and Arrange) algorithm, and a 6-week supply of nicotine replacement therapy. The control intervention will consist of an active referral to the Maltese National Health Service's one-to-one smoking cessation support service, which is based on motivational interviewing. The primary feasibility and acceptability outcomes include the recruitment and participation rates, resources used, problems identified by the nurses, the nurses' perceived challenges and facilitators to implementation and the nurses' and patients' acceptability of the study intervention. Data analyses will be descriptive, with quantitative feasibility and acceptability outcomes reported with 95% confidence intervals.Ethics and disseminationEthical clearance was obtained from the Faculty of Health Sciences Research Ethics Committee, University of Malta. The study results will be disseminated through conference presentations and a publication in a peer-reviewed journal.Trial registration numberNCT05920096.
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Project description:ObjectiveWe conducted a randomized controlled trial to determine whether IRISS (Intervention for those Recently Informed of their Seropositive Status), a positive affect skills intervention, improved positive emotion, psychological health, physical health, and health behaviors in people newly diagnosed with HIV.MethodOne-hundred and fifty-nine participants who had received an HIV diagnosis in the past 3 months were randomized to a 5-session, in-person, individually delivered positive affect skills intervention or an attention-matched control condition.ResultsFor the primary outcome of past-day positive affect, the group difference in change from baseline over time did not reach statistical significance (p = .12, d = .30). Planned secondary analyses within assessment point showed that the intervention led to higher levels of past-day positive affect at 5, 10, and 15 months postdiagnosis compared with an attention control. For antidepressant use, the between group difference in change from baseline was statistically significant (p = .006, d = -.78 baseline to 15 months) and the difference in change over time for intrusive and avoidant thoughts related to HIV was also statistically significant (p = .048, d = .29). Contrary to findings for most health behavior interventions in which effects wane over the follow up period, effect sizes in IRISS seemed to increase over time for most outcomes.ConclusionsThis comparatively brief positive affect skills intervention achieved modest improvements in psychological health, and may have the potential to support adjustment to a new HIV diagnosis. (PsycINFO Database Record
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Project description:BackgroundType 2 diabetes poses public health challenges for Māori and Pasifika communities in Australia. The women of these communities face a greater burden from type 2 diabetes-related mortality and comorbidities. Lifestyle modification behaviors through previous women's wellness programs have been shown to reduce the risk of developing complications in established type 2 diabetes. The Pasifika Women's Diabetes Wellness Program (PWDWP) pilot study, co-designed with Māori and Pasifika communities, was aimed at addressing late hospital presentations from diabetes-related complications.ObjectiveThis study (1) examines the efficacy of women with type 2 diabetes in the intervention group for improved glycated hemoglobin (HbA1c) clinical levels and diabetes self-management compared with the control group from baseline (T0) to week 12 (T1) and week 24 (T2; postintervention) and (2) assesses the cultural adaptability, acceptability, and feasibility of the pilot intervention for future studies.MethodsThis study uses a quasiexperimental design that involves a 24-week intervention. We recruited 50 Māori and Pasifika women with type 2 diabetes (25 in the intervention group from the south side of Brisbane and 25 in the control group from the north side of Brisbane) using participatory talanoa methodologies. The intervention group participated in face-to-face and virtual whānau education workshops (5 weeks) and had access to individual coaching and virtual support delivered by trained Māori and Pasifika health professionals and community health workers. The control group received usual care with their identified health provider. Both groups received copies of the PWDWP journal, fact sheets, and a health check passbook with tailored motivational text messages. An advisory committee was set up to oversee the program implementation, including protocols of engagement, health checks, and data collection in community settings. The quantitative data were collected at T0, T1, and T2 with HbA1c as the primary outcome measure. Secondary outcomes measured changes in diabetes self-care and body composition (eg, BMI, waist circumference). Qualitative data will ascertain the program's feasibility and cultural adaptability using talanoa focus groups.ResultsThis pilot study was approved by the Queensland University of Technology Human Ethic Research Committee (5609) and began in January 2023 after participant recruitment between July 2022 and December 2022. The final data collection including the health check, focus group, and survey data was completed in November 2023, and data analysis and reporting are expected to conclude in 2024.Conclusions This study provides a blueprint for PWDWP. Collaborative partnerships with community organizations and stakeholders are crucial for program success and suggest a potential model for targeting diabetes management for Māori and Pasifika communities, emphasizing the need for culturally relevant interventions. The findings will have significant implications for policymakers and practitioners when developing and implementing public health initiatives, particularly for communities with unique cultural nuances.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12622001100785p; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384470&isReview=true.International registered report identifier (irrid)DERR1-10.2196/55435.
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