ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31615 results sorted by trial registration date.
  • A multi-component intervention for smoking cessation among Australian male prison inmates

    .Aim To evaluate the efficacy of nortriptyline (NOR) added to a multi-component smoking cessation intervention, which included cognitive–behavioural therapy (CBT) and provision of nicotine replacement therapy (NRT). Design Randomized controlled trial (RCT) comparing two study groups with blinded follow-up at 3, 6 and 12 months. Both groups received amulti-component smoking cessation intervention comprising two half-hour individual sessions of CBT and NRT with either active NOR or placebo. Setting Prisons in New South Wales (17) and Queensland (one), Australia. Participants A total of 425 male prisoners met inclusion criteria and were allocated to either treatment (n = 206) or control group (n = 219). Measurements Primary end-points at 3, 6 and 12 months were continuous abstinence, point prevalence abstinence and reporting a 50% reduction in smoking. Smoking status was confirmed by expired carbon monoxide, using a cut-point of ;10 parts per million. Findings Participants’ demographics and baseline tobacco usewere similar in treatment and control groups. Based on an intention-to-treat analysis, continuous abstinence between the treatment and control groups was not significantly different at 3 months (23.8 versus 16.4%), 6 months (17.5 versus 12.3%) and 12 months (11.7 versus 11.9%). Conclusion Adding nortriptyline to a smoking cessation treatment package consisting of behavioural support and nicotine replacement therapy does not appear to improve long-term abstinence rates in male prisoners.

  • To evaluate the psychometric properties and user acceptability of the patient completed Peter Mac Supportive Needs Screening Tool (SNST).

    This project is an attempt to measure the reliability and validity of the Peter Mac Supportive Needs Screening Tool (SNST). The Peter Mac SNST was developed for use in clinical practice to facilitate a system to identify need early and a process for planning of appropriate intervention. Specifically the study aims to assess: 1) the content validity (the extent to which the tool includes the relevant domains of cancer patients’ supportive care needs); 2) the construct validity (the extent to which the tool accurately identifies supportive care needs); and 3) assess the reliability of the tool, the extent to which the tool is a consistent measure of supportive care needs. This project will look at the correlation of the answers of the anxiety and depression domain from the Peter Mac SNST with the Supportive Care Needs Survey (SCNS) and the Brief Symptom Inventory (BSI-18), two tools previously validated in the cancer population, to identify the construct validity in this domain. The construct validity of three other domains will be evaluated by comparing the matching domains of Peter Mac SNST with the SCNS. Testing the reliability of the tool within a short time frame will also be undertaken. There was no blinding as participants were aware that they were either filling in three forms whilst waiting for their appointment or were completing only one.

  • The effect of simplified stool sampling on participation in colon cancer screening

    There has been limited uptake of population screening for colorectal cancer in Australia and other western countries, using faecal occult blood testing. We have previously determined that the InSure faecal immunochemical test (FIT) used in single sample format has similar sensitivity for significant colorectal neoplasia (cancer and significant adenomas) relative to the standard two stool sample test. Our hypothesis is that single stool sampling will result in improved population participation in screening compared to the standard InSure test. This study will compare population participation in screening in two groups, one offered the screening test in single stool sample format, compared to the control (standard InSure test, 2 stool sample format).

  • Manual therapies for osteoarthritis: A pilot study

    First study in a series of three pilot clinical trials. Three way comparison of the effects of 2 manual therapies adjunctive to usual care with usual care alone on health-related quality of life in people with osteoarthritis. Study is complete. Trial registration is required in order to publish a report of the trial in a journal.

  • Does the design of the Proseal reduce the incidence of gastro-oesophageal reflux?

    On arrival to the anaesthetic room patients will have non-invasive monitoring established and a venous access line placed under local anaesthesia prior to induction of general anaesthesia. Following pre-oxygenation of the patient, induction of anaesthesia will be carried out by the anaesthetist in charge of the case. Intravenous fentanyl (2mcg.kg-1), followed by an induction dose of propofol (1-3mg.kg-1) will be given. The patients allocated to the IPPV group will be given intravenous rocuronium (0.6mg.kg-1). Once an adequate depth of anaesthesia has been reached a ProSeal laryngeal mask airway (PLMA) will be inserted as per the manufactures recommended technique. Anaesthesia will be maintained on 2% sevoflurane in 0.5 litre.min-1 oxygen and 1 litre.min-1 nitrous oxide for both spontaneous breathing and intermittent positive pressure ventilation (IPPV) patients. Intermittent positive pressure ventilation (IPPV) will be delivered with a tidal volume of 10ml.kg-1 and a respiratory rate of 8-14 breaths per minute. A Zinetics 24ME multi-use pH catheter with external reference electrode will then be advanced through the drainage port of the ProSeal laryngeal mask airway (PLMA). The electrode will be advanced into the stomach which will be confirmed by pH levels of less the 3. It will then be slowly withdrawn to the gastro-oesophageal junction, the site being indicated by an abrupt increase in the pH recorded to levels above 5. It will then be withdrawn a further 4-5cm to be positioned at the mid-oesophagus. At the completion of the case the patient will be woken and the pH catheter and ProSeal laryngeal mask airway (PLMA) removed. The investigator will be blinded to all pH measurements following the insertion of the catheter. The recording will be subsequently transferred to a computer to be analysed with Polygram 98 Diagnostic Workstation software by an investigator blinded to the anaesthetic technique.

  • Joint mobilisation and water exercise for quality of life in osteoarthritis

    Third study in a series of three pilot clinical trials. Four way comparison of the effects of manual therapy (joint mobilisation), water exercise, and both interventions adjunctive to usual care with usual care alone on health-related quality of life in people with osteoarthritis. Study is complete. Trial registration is required in order to publish a report of the trial in a journal.

  • Comparison of success rate, speed of insertion and acute complication rates of central venous catheter (CVC) insertion between using ultrasound guidance technique and traditional anatomical landmark technique in elective surgery

    A prospective randomised controlled trial to assess the potential benefits and acute complication rates of ultrasound guided CVC insertion with traditional anatomical landmark insertion technique

  • An investigation into the relationship between Sleep, Pain and Depression

    This research is being conducted in an effort to understand how improvements in sleep may affect factors related to pain and mood. There are three components to this research project, a group Cognitive Behavioural Therapy program, a Sleep Hygiene program, where participants are provided with reading material on how they can improve their sleep, and a wait list. The wait list is an important part of the study because it will provide information about how sleep patterns change over time. This study has two main hypotheses. The first is that the Cognitive Behavioural Therapy program will lead to greater improvements in sleep quality and quantity than the sleep hygiene program and the second is that improved sleep quantity and/or quality will increase individuals’ ability to cope with or manage pain.

  • The effectiveness of proactive telemarketing of a smoking cessation telephone counselling service

    Households are selected at random from the New South Wales Electronic White Pages. Each household is contacted by telephone to establish if there is an adult daily smoker resident. If more then one daily smoker lives in the household one smoker is selected at random. Consenting smokers are randomly allocated to receive either proactive telephone counselling calls or a one-off mail-out of written self-help materials. The assessor (ie, telephone interviewer) is unaware of group assignment as computer software allocates participants to conditions. Participants complete telephone interviews at 4, 7 and 13 months post-recruitment to examine quitting behaviours. It is hypothesised that compared to the written self-help group, significantly more participants in the telephone counselling group will have quit smoking at 4, 7 and 13 months post-recruitment.

  • To facilitate the implementation of the NHMRC “Clinical practice guidelines for the psychosocial care of adults with cancer”

    It is proposed to test the refinement and dissemination of the C-CARE model of psychosocial assessment more broadly across the tumour streams at Peter Mac in the first instance and then to further refine the model in the Western and Central ICS (W&CICS) and in two Regional Integrated Cancer Services. The impetus for this project is two fold: the publication of the NHMRC Clinical Practice Guidelines for the Psychosocial Care of Adults with Cancer (NBCC & NCCI 2003) and the prioritization of psychosocial assessment within the Victorian Cancer Services Improvement Program. Funding for this project has been provided by the Department of Human Services.

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