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Alternative forms of hydration in patients with cancer in the last days of life: study protocol for a randomised controlled trial.

ABSTRACT: The provision of clinically assisted hydration at the end of life is one of the most contentious issues in medicine, and indeed within the general population. The reasons for contention include: a) the lack of evidence for or against; b) the disparate opinions of healthcare professionals; and c) the generally positive opinions of patients and their carers about clinically assisted hydration.The study is a cluster randomised trial to assess the feasibility of conducting an adequately powered, randomised controlled trial of clinically assisted hydration in patients with cancer in the last days of life. Twelve sites, four National Health Service (NHS) hospitals and eight NHS/voluntary sector hospices in the United Kingdom, will be randomised to give either standard intervention A: continuance of oral intake and regular mouth care, or standard intervention B: continuance of oral intake, regular mouth care and clinically assisted hydration. Patients will be included if they: i) have a diagnosis of cancer; ii) are aged ? 18 yr; iii) have an estimated prognosis of ? 1 week and iv) are unable to maintain sufficient oral intake (1 L per day, measured/estimated); and v) are able to give informed consent. Patients will be excluded if they have contra-indications to receiving clinically assisted hydration. The primary endpoint of interest is the frequency of hyperactive delirium ('terminal agitation'), and this will be assessed using the Modified Richmond Agitation and Sedation Scale (administered every four hours). Other data to be collected include the frequency of pain, respiratory secretions ('death rattle'), dyspnoea, nausea and vomiting, adverse effects to clinically assisted hydration and overall survival. In addition, data will be collected on the use of anti-psychotic drugs, sedative drugs, analgesics, anti-secretory drugs and other end-of-life medication. The study has obtained full ethical approval.A randomised controlled trial of clinically assisted hydration in end-of-life care is urgently required. This feasibility study will allow methodological and ethical issues to be understood and addressed to ensure that a robust, adequately powered, randomised controlled trial is designed.ClinicalTrials.gov NCT02344927 (registered 4 June 2014).

SUBMITTER: Davies A

PROVIDER: S-EPMC4607172 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature

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Alternative forms of hydration in patients with cancer in the last days of life: study protocol for a randomised controlled trial.

Davies Andrew A Waghorn Melanie M Boyle Julia J Gallagher Ann A Johnsen Sigurd S

Trials 20151014

<h4>Background</h4>The provision of clinically assisted hydration at the end of life is one of the most contentious issues in medicine, and indeed within the general population. The reasons for contention include: a) the lack of evidence for or against; b) the disparate opinions of healthcare professionals; and c) the generally positive opinions of patients and their carers about clinically assisted hydration.<h4>Methods/design</h4>The study is a cluster randomised trial to assess the feasibilit ...[more]

PMID: 26466809

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Project description:BackgroundThe Holocaust was one of the most traumatic catastrophes in recorded human history. Survivors seeking psychotherapeutic help today, now in their seventies and older, often show symptoms of a posttraumatic stress disorder (PTSD), depression, or prolonged grief disorder. Established psychological treatments for PTSD (e.g. cognitive behaviour therapy, psychodynamic therapies) have been tested and assessed mainly with young and middle-aged adults; only very few studies examined them in old age. There is no therapy outcome study known to us for any treatment mode for Holocaust survivors. Moreover, there is a need for an age group-specific treatment of PTSD and other stress-related mental disorders. A narrative approach including life-review and narrative exposure seems to meet very well the natural need of older people to review their lives and is highly effective. However, most studies on the efficacy of life review therapy (LRT) focus on late-life depression. There is a lack of efficacy studies evaluating the effect of LRT on PTSD symptoms in older individuals that have experienced traumatic events.MethodsThe main goal of this study is to evaluate the effect of LRT for Holocaust survivors (LRT-HS) on symptoms of PTSD and related mental health problems (depression, anxiety, prolonged grief), compared to a supportive control group. A secondary goal is to identify the characteristics of participants that seem to especially benefit from the treatment. The proposed study is a randomised, controlled follow-up trial including Holocaust survivors with one or more trauma-related disorders. The LRT treatment consists of 20-25 sessions. Before and after the treatment phase, participants in both conditions will be assessed. Follow-up will take place 6 months after the treatment. A sample size of 80 is required (drop-out rate included).DiscussionEfficacious treatments for trauma-related disorders in older people are of high importance, also because the probability of traumatisation and loss increases with age. Because this study is conducted with this specific group of multiply traumatised people, we are convinced that the results can easily transfer to other samples.Trial registrationISRCTN, ISRCTN12823306. Registered 31 March 2018 - Retrospectively registered (first participant 22 December 2017).

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Alternative forms of hydration in patients with cancer in the last days of life: study protocol for a randomised controlled trial.

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Alternative forms of hydration in patients with cancer in the last days of life: study protocol for a randomised controlled trial.

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