17 Result(s)

Article

Supported exercise TrAining for Men wIth prostate caNcer on Androgen deprivation therapy (STAMINA): study protocol for a randomised controlled trial of the clinical and cost-effectiveness of the STAMINA lifestyle intervention compared with optimised usual care, including internal pilot and parallel process evaluation

UK national clinical guidance recommends that men with prostate cancer on androgen deprivation therapy are offered twice weekly supervised aerobic and resistance exercise to address iatrogenic harm caused by t...

Emma McNaught, Sophie Reale, Liam Bourke, Janet E. Brown, Michelle Collinson… in Trials (2024)

Article

Using healthcare systems data for outcomes in clinical trials: issues to consider at the design stage

Healthcare system data (HSD) are increasingly used in clinical trials, augmenting or replacing traditional methods of collecting outcome data. This study, PRIMORANT, set out to identify, in the UK context, iss...

Alice-Maria Toader, Marion K. Campbell, Jennifer K. Quint, Michael Robling… in Trials (2024)

Article

Acceptance and Commitment Therapy to support medication decision-making and quality of life in women with breast cancer: protocol for a pilot randomised controlled trial

Adherence to adjuvant endocrine therapy is affected by medication side-effects and associated distress. Previous interventions focused on educating women to enhance adherence have proved minimally effective. W...

Samuel G. Smith, Rachel Ellison, Louise Hall, Jane Clark… in Pilot and Feasibility Studies (2022)

Article

A cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment and attendance in a childhood obesity prevention programme: results of the Optimising Family Engagement in HENRY (OFTEN) trial

Poor and variable implementation of childhood obesity prevention programmes reduces their population impact and sustainability. We drew upon ethnographic work to develop a multi-level, theory-based implementat...

Maria Bryant, Wendy Burton, Michelle Collinson, Amanda Farrin, Jane Nixon… in Trials (2021)

Article

The DANTE trial protocol: a randomised phase III trial to evaluate the Duration of ANti-PD-1 monoclonal antibody Treatment in patients with metastatic mElanoma

Immunotherapy is revolutionising the treatment of patients diagnosed with melanoma and other cancers. The first immune checkpoint inhibitor, ipilimumab (targeting cytotoxic T-lymphocyte-associated antigen 4 (C...

Oliver Coen, Pippa Corrie, Helen Marshall, Ruth Plummer… in BMC Cancer (2021)

Article

Contamination within trials of community-based public health interventions: lessons from the HENRY feasibility study

Contamination occurs when participants allocated to trial control arms receive elements of the active intervention. Randomisation at cluster level, rather than individual level, may reduce or eliminate contami...

Elizabeth Stamp, Holly Schofield, Victoria Laurina Roberts… in Pilot and Feasibility Studies (2021)

Article

Cluster randomised controlled feasibility study of HENRY: a community-based intervention aimed at reducing obesity rates in preschool children

Community-based obesity prevention interventions are often commissioned despite the limited evidence base. HENRY (Health, Exercise, Nutrition for the Really Young) is a programme delivered to parents of presch...

Maria Bryant, Michelle Collinson, Wendy Burton… in Pilot and Feasibility Studies (2021)

Article

Problem-solving therapy rather than treatment as usual for adults after self-harm: a pragmatic, feasibility, randomised controlled trial (the MIDSHIPS trial)

Non-fatal self-harm is one of the commonest reasons for adults’ emergency hospital attendance. Although strongly associated with fatal and non-fatal repetition, there is weak evidence about effective intervent...

David Owens, Alexandra Wright-Hughes, Liz Graham… in Pilot and Feasibility Studies (2020)

Article

Cluster randomised controlled feasibility study of HENRY: a community-based intervention aimed at reducing obesity rates in preschool children

In the UK and beyond, public funding is used to commission interventions delivered in public health early years settings aimed at improving health and well-being and reducing inequalities in order to promote s...

Maria Bryant, Wendy Burton, Michelle Collinson… in Pilot and Feasibility Studies (2018)

Article

Effectiveness of an implementation optimisation intervention aimed at increasing parent engagement in HENRY, a childhood obesity prevention programme - the Optimising Family Engagement in HENRY (OFTEN) trial: study protocol for a randomised controlled trial

Family-based interventions to prevent childhood obesity depend upon parents’ taking action to improve diet and other lifestyle behaviours in their families. Programmes that attract and retain high numbers of p...

Maria Bryant, Wendy Burton, Bonnie Cundill, Amanda J. Farrin, Jane Nixon… in Trials (2017)

Article

Self-Harm Intervention: Family Therapy (SHIFT), a study protocol for a randomised controlled trial of family therapy versus treatment as usual for young people seen after a second or subsequent episode of self-harm 

Self-harm is common in the community with a lifetime prevalence of 13 %. It is associated with an elevated risk of overall mortality and suicide. People who harm themselves are high users of public services. E...

Alexandra Wright-Hughes, Elizabeth Graham, Amanda Farrin, Michelle Collinson… in Trials (2015)

Article

Prevention of delirium (POD) for older people in hospital: study protocol for a randomised controlled feasibility trial

Delirium is the most frequent complication among older people following hospitalisation. Delirium may be prevented in about one-third of patients using a multicomponent intervention. However, in the United Kin...

John Young, Francine Cheater, Michelle Collinson, Marie Fletcher, Anne Forster… in Trials (2015)

Article

MIDSHIPS: Multicentre Intervention Designed for Self-Harm using Interpersonal Problem-Solving: protocol for a randomised controlled feasibility study

Around 150,000 people each year attend hospitals in England due to self-harm, many of them more than once. Over 5,000 people die by suicide each year in the UK, a quarter of them having attended hospital in th...

Michelle Collinson, David Owens, Paul Blenkiron, Kayleigh Burton, Liz Graham… in Trials (2014)

Article

Pilot trial of Stop Delirium! (PiTStop) - a complex intervention to prevent delirium in care homes for older people: study protocol for a cluster randomised controlled trial

Delirium (or acute confusion) is a serious illness common in older people, in which a person’s thinking and perceptions may be affected. Reducing delirium is important because of the considerable distress it c...

Anne Heaven, Francine Cheater, Andrew Clegg, Michelle Collinson, Amanda Farrin… in Trials (2014)

Article

Designing and analysing feasibility studies of complex interventions: challenges related to assessing stop/go criteria

Michelle Collinson, Shamaila Anwar, Liz Graham, Kayleigh Burton, Tamar Pincus… in Trials (2013)

Article

Testing the credibility, feasibility and acceptability of an optimised behavioural intervention (OBI) for avoidant chronic low back pain patients: protocol for a randomised feasibility study

Chronic back pain continues to be a costly and prevalent condition. The latest NICE guidelines issued in 2009 state that for patients with persistent back pain (of between six weeks and twelve months duration)...

Tamar Pincus, Shamaila Anwar, Lance McCracken, Alison McGregor, Liz Graham… in Trials (2013)

Article

Designing and analysing pragmatic clinical trials of complex interventions in mental health: challenges and solutions

Amanda J Farrin, Michelle Collinson in Trials (2011)