The impact of physical activity on fatigue and quality of life in lung cancer patients: a randomised controlled trial protocol

Abstract Background Multiple sclerosis (MS) is a chronic, degenerative disease of the central nervous system. Because of the long-term and unpredictable nature of the disease, the burden of MS is significant from both a patient and societal perspective. Despite a recent influx of disease-modifying therapies to treat MS, many individuals continue to experience disability that negatively affects productivity and quality of life. Previous research indicates that physical activity has a positive impact on walking function in individuals with MS, in addition to the usual beneficial effects on overall health. However, most people with MS are not active enough to gain these benefits, and a lack of support to initiate and maintain physical activity has been identified as a major barrier. This study will evaluate the impact of a novel intervention involving individualised behaviour change strategies delivered by neurophysiotherapists on increasing physical activity levels in individuals with MS who are currently inactive. Methods/design This single-blind, parallel-group, randomised controlled trial will be conducted in Saskatchewan, Canada. Eligible participants include individuals with MS who are ambulatory but identified as currently inactive by the self-reported Godin Leisure-Time Exercise Questionnaire (GLTEQ). The intervention will be delivered by neurophysiotherapists and includes individualised behaviour change strategies aimed at increasing physical activity over a 12-month period. The control group will receive usual care during the 12-month study period. The primary outcome is the change in physical activity level, as measured by the change in the GLTEQ score from baseline to 12 months. Secondary outcomes include the change in patient-reported outcome measures assessing MS-specific symptoms, confidence and quality of life. Discussion Physical activity has been identified as a top research priority by the MS community. Findings from this novel study may result in new knowledge that could significantly impact the management and overall health of individuals with MS. Trial registration ClinicalTrials.gov, NCT04027114. Registered on 10 July 2019.

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Nurse-led, screening-triggered, early specialised palliative care intervention programme for patients with advanced lung cancer: study protocol for a multicentre randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-037759 ◽

2020 ◽

Vol 10 (11) ◽

pp. e037759

Author(s):

Daisuke Fujisawa ◽

Shigeki Umemura ◽

Ayumi Okizaki ◽

Eriko Satomi ◽

Takuhiro Yamaguchi ◽

...

Keyword(s):

Quality Of Life ◽

Lung Cancer ◽

Palliative Care ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Advanced Lung Cancer ◽

Intervention Programme ◽

Care Intervention ◽

Randomised Controlled

IntroductionIt has been suggested that palliative care integrated into standard cancer treatment from the early phase of the disease can improve the quality of life of patients with cancer. In this paper, we present the protocol for a multicentre randomised controlled trial to examine the effectiveness of a nurse-led, screening-triggered, early specialised palliative care intervention programme for patients with advanced lung cancer.Methods and analysisA total of 206 patients will be randomised (1:1) to the intervention group or the control group (usual care). The intervention, triggered with a brief self-administered screening tool, comprises comprehensive need assessments, counselling and service coordination by advanced-level nurses. The primary outcome is the Trial Outcome Index of the Functional Assessment of Cancer Therapy (FACT) at 12 weeks. The secondary outcomes include participants’ quality of life (FACT-Lung), depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), illness perception (Prognosis and Treatment Perceptions Questionnaire), medical service use and survival. A mixed-method approach is expected to provide an insight about how this intervention works.Ethics and disseminationThis study has been approved by the Institutional Review Board of the National Cancer Center Japan (approval number: 2016-235). The findings will be disseminated through peer-reviewed publications and conference presentations and will be reflected on to the national healthcare policy.Trial registration numberUMIN000025491.

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A randomised controlled trial comparing the impact of problem-solving treatment and usual care on wellbeing, functional mobility and quality of life of blind and partially sighted people

http://isrctn.com/ ◽

10.1186/isrctn87854656 ◽

2013 ◽

Author(s):

Trefor Aspden

Keyword(s):

Quality Of Life ◽

Problem Solving ◽

Randomised Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Functional Mobility ◽

Randomised Controlled ◽

Partially Sighted ◽

The Impact

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Renewed: Protocol for a randomised controlled trial of a digital intervention to support quality of life in cancer survivors

BMJ Open ◽

10.1136/bmjopen-2018-024862 ◽

2019 ◽

Vol 9 (3) ◽

pp. e024862 ◽

Cited By ~ 3

Author(s):

Adele Krusche ◽

Katherine Bradbury ◽

Teresa Corbett ◽

Jane Barnett ◽

Beth Stuart ◽

...

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Randomised Controlled Trial ◽

Cancer Survivors ◽

Controlled Trial ◽

Well Being ◽

Improve Quality ◽

Randomised Controlled ◽

Human Support

IntroductionLow quality of life is common in cancer survivors. Increasing physical activity, improving diet, supporting psychological well-being and weight loss can improve quality of life in several cancers and may limit relapse. The aim of the randomised controlled trial outlined in this protocol is to examine whether a digital intervention (Renewed), with or without human support, can improve quality of life in cancer survivors. Renewed provides support for increasing physical activity, managing difficult emotions, eating a healthier diet and weight management.Methods and analysisA randomised controlled trial is being conducted comparing usual care, access to Renewed or access to Renewed with brief human support. Cancer survivors who have had colorectal, breast or prostate cancer will be identified and invited through general practice searches and mail-outs. Participants are asked to complete baseline measures immediately after screening and will then be randomised to a study group; this is all completed on the Renewed website. The primary outcome is quality of life measured by the European Organization for Research and Treatment of Cancer QLQ-c30. Secondary outcomes include anxiety and depression, fear of cancer recurrence, general well-being, enablement and items relating to costs for a health economics analysis. Process measures include perceptions of human support, intervention usage and satisfaction, and adherence to behavioural changes. Qualitative process evaluations will be conducted with patients and healthcare staff providing support.Ethics and disseminationThe trial has been approved by the NHS Research Ethics Committee (Reference 18/NW/0013). The results of this trial will be published in peer-reviewed journals and through conference presentations.Trial registration numberISRCTN96374224; Pre-results.

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Study protocol: Randomised controlled trial to evaluate the impact of an educational programme on Alzheimer’s disease patients’ quality of life

Alzheimer s Research & Therapy ◽

10.1186/s13195-014-0066-1 ◽

2014 ◽

Vol 6 (5-8) ◽

Cited By ~ 1

Author(s):

Hélène Villars ◽

Virginie Gardette ◽

Amélie Perrin ◽

Christophe Hein ◽

Sophie Elmalem ◽

...

Keyword(s):

Quality Of Life ◽

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Randomised Controlled Trial ◽

Study Protocol ◽

Controlled Trial ◽

Educational Programme ◽

Randomised Controlled ◽

The Impact

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A Randomised Controlled Trial of a Digital Therapy for Diabetes Prevention Among High Risk Individual: Study Protocol (the Mydipp Trial)

10.21203/rs.3.rs-22426/v1 ◽

2020 ◽

Author(s):

Nurul Fatihah Mohd Fauzi ◽

Sharifah Wajihah Wafa ◽

Naresh Bhaskar Raj ◽

Mohd Ibrahim Abdullah ◽

Barakatun Nisak Mohd Yusof ◽

...

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Type 2 Diabetes ◽

Randomised Controlled Trial ◽

Diabetes Prevention ◽

Controlled Trial ◽

Parallel Group ◽

Randomised Controlled

Abstract Background: Approximately 37% of the individuals with prediabetes will have diabetes in four years if they do not change their lifestyle through any intervention. Lifestyle modification intervention has shown to be effective in reducing or delaying the onset of type 2 diabetes mellitus (T2DM) among high-risk individuals. Some intervention approaches integrate human coaching into technology using phone or email to enable wider reach, known as digital therapy. It is considered as a scalable method to reach a larger population who are at risk, convenient and accessible. This study aims to determine the feasibility and efficacy of lifestyle intervention to prevent type 2 diabetes among adults who are at risk of developing diabetes, an assessor-blinded, parallel-group, randomised controlled trial using the Malaysia Diabetes Prevention Programme (MyDiPP) app.Methods: ‘MyDiPP’ is a 12-month lifestyle intervention digital therapy with multiple approaches (weight loss, dietary modification, physical activity and quality of life). Eligible adults are aged 18-65 years, overweight/obese (BMI ≥ 23 kgm2) and athigh-risk for type2diabetes (American Diabetes Association(ADA) Diabetes Risk Score ≥ 5, or HbA1c of 5.6-6.2%). Each participant will be randomly assigned to one oftwo study groups in 1:1 ratio using simple randomisation to intervention or usual care control groups. The primary outcome is the change in weight at 6 months and 12 months, while the secondary outcomes are changes in HbA1c level, physical activity level, dietary intake and quality of life. The MyDiPP programme is an assessor-blinded, parallel-group, randomised controlled trial, in which the app consists of educational lessons, group, technology-enabled discussions, tools to track nutritional intake, physical activity, body weight and blood glucose level as well as platform to communicate with the health coaches. Discussion: This study is necessary to determine to what extent the intervention programme reduces risks of diabetes risk in comparison to the usual care.Trial registration details:This trial was prospectively registered with Clinical Trial Registry (CTR) on 21st June 2019 with trial registration number NCT03997656.

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