Sue-Ann Carmont

The needs of cancer patients and their families from rural and remote areas of Queensland

This study examines the impact of travelling for treatment on cancer patients and their families. Twenty-eight consecutive cancer patients, who were receiving radiation therapy treatment and 19 family carers, completed a structured needs assessment questionnaire and an in-depth interview. Both patients and carers reported moderate to high levels of unmet psychological need. Carers were found to have higher levels of anxiety than patients, although both groups had higher anxiety levels than the general population. Taking more responsibility for household tasks and organising new living arrangements for the family were the most frequently identified demands of a dual burden of caring. Nearly 40% of carers reported some disruption to their schedule and half reported experiencing financial difficulties. The qualitative interviews highlight the disruption that parents and children experience under the present system, particularly in relation to the demands of family life and the need to maintain some level of continuity and security for children.

Can technology and the media help reduce dysfunctional parenting and increase engagement with preventative parenting interventions

In an evaluation of the television series “Driving Mum and Dad Mad,” 723 families participated and were randomly assigned to either a standard or technology enhanced viewing condition (included additional Web-support). Parents in both conditions reported significant improvements from pre- to postintervention in their childs behavior, dysfunctional parenting, parental anger, depression, and self-efficacy. Short-term improvements were maintained at 6-months follow-up. Regressions identified predictors of program outcomes and level of involvement. Parents who watched the entire series had more severe problems at preintervention and high sociodemographic risk than parents who did not watch the entire series. Few sociodemographic, child, or parent variables assessed at preintervention predicted program outcomes or program engagement, suggesting that a wide range of parents from diverse socioeconomic status benefited from the program. Media interventions depicting evidence-based parenting programs may be a useful means of reaching hard to engage families in population-level child maltreatment prevention programs.

Pilot Study To Determine the Optimal Dose of Methylphenidate for an n-of-1 Trial for Fatigue in Patients with Cancer

PURPOSE In advanced cancer, the prevalence of fatigue is high and can be related to treatment or disease. Methylphenidate hydrochloride (MPH) is a central nervous system stimulant that has been used to palliate fatigue. There is no standard dose for MPH when used for this indication; recommended doses range from 5–20 + mg/d. METHOD To identify a dose to test formally in a subsequent n-of-1 trial of fatigue, we recruited patients with advanced cancer and a fatigue score of 4 or more on a 10-point scale. Following a 3-day baseline assessment, each patient titrated MPH at doses ranging from 5 mg/d to 15 mg twice daily at 3-day intervals. In a daily diary, patients recorded measures of fatigue, depression, toxicity, and symptom control. RESULTS Ten patients provided consent, 9 completed 8 days and 5 received maximum dose at day 15. Three patients were unwilling to increase the dose to maximum levels as they were satisfied with the response at a lower dose. Across all patients, there was a pattern of rapidly improving fatigue and depression scores to day 9 (5 mg twice daily), with minimal improvement thereafter. CONCLUSION The results indicate a dose of 5 mg twice daily for the definitive study. There was little correlation between performance status and maximum tolerated dose. No patient withdrew because of toxicity.

Using aggregated single patient (N-of-1) trials to determine the effectiveness of psychostimulants to reduce fatigue in advanced cancer patients: a rationale and protocol

BackgroundIt is estimated that 29% of deaths in Australia are caused by malignant disease each year and can be expected to increase with population ageing. In advanced cancer, the prevalence of fatigue is high at 70–90%, and can be related to the disease and/or the treatment. The negative impact of fatigue on function (physical, mental, social and spiritual) and quality of life is substantial for many palliative patients as well as their families/carers.Method/designThis paper describes the design of single patient trials (n-of-1 s or SPTs) of a psychostimulant, methylphenidate hydrochloride (MPH) (5 mg bd), compared to placebo as a treatment for fatigue, with a population estimate of the benefit by the aggregation of multiple SPTs. Forty patients who have advanced cancer will be enrolled through specialist palliative care services in Australia. Patients will complete up to 3 cycles of treatment. Each cycle is 6 days long and has 3 days treatment and 3 days placebo. The order of treatment and placebo is randomly allocated for each cycle. The primary outcome is a reduction in fatigue severity as measured by the Functional Assessment of Cancer Therapy-fatigue subscale (FACIT-F). Secondary outcomes include adverse events, quality of life, additional fatigue assessments, depression and Australian Karnovsky Performance Scale.DiscussionThis study will provide high-level evidence using a novel methodological approach about the effectiveness of psychostimulants for cancer-related fatigue. If effective, the findings will guide clinical practice in reducing this prevalent condition to improve function and quality of life.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12609000794202

Central nervous system stimulants for secondary attention deficit-hyperactivity disorder after paediatric traumatic brain injury: a rationale and protocol for single patient (n-of-1) multiple cross-over trials

BackgroundIt is estimated that 22,800 children were living with an Acquired Brain Injury (ABI) (0.6% of children aged under 15 years) in Australia during 2003. Many children after a traumatic brain injury will experience difficulties with attention and concentration; a condition termed secondary Attention Deficit-Hyperactivity Disorder. There is conflicting evidence on whether treatment with stimulant therapy with medications such as methylphenidate or dexamphetamine will improve the attention and behavior of children with this condition.Methods/DesignSingle patient trials (n-of-1s or SPTs) evaluate the effect of titrated doses of psychostimulants methylphenidate or dexamphetamine compared to placebo on attention and behavior, in children with TBI and secondary ADHD. The aggregation of multiple SPTs will produce a population estimate of the benefit. Forty-two children will be registered into the trial through rehabilitation services at three large children’s hospitals in Australia. Patients will complete up to 3 cycles of treatment. Each cycle is 2 weeks long comprising seven days each of treatment and placebo, with the first two days of each cycle considered a washout period and the data not analysed. The order of treatment and placebo is randomly allocated for each cycle. The Conners’ Parent Rating Scales long forms will be employed to measure change in attention-deficit/hyperactivity and related problems of the child, and the primary outcome measure is the Conners’ Global Index Parent Version. Secondary outcomes include the teacher and child (if aged > 12 years) Conners’ Rating Scales, the Behaviour Rating Inventory of Executive Function among other measures. This study will provide high-level evidence using a novel methodological approach to inform clinicians about the most appropriate treatment for individual children. Through aggregation of individual trials, a population estimate of treatment effect will be provided to guide clinical practice in the treatment of children with secondary ADHD after a traumatic brain injury.DiscussionThis study employs an innovative methodological approach on the effectiveness of CNS stimulants for secondary ADHD from a brain injury. The findings will both guide clinicians on treatment recommendations, and inform the concept and acceptance of SPTs in paediatric research.Trial registrationAustralian New Zealand Clinical Trials Registry. ACTRN12609000873224

Do pilocarpine drops help dry mouth in palliative care patients: a protocol for an aggregated series of n-of-1 trials

BackgroundIt is estimated that 39,000 Australians die from malignant disease yearly. Of these, 60% to 88% of advanced cancer patients suffer xerostomia, the subjective feeling of mouth dryness. Xerostomia has significant physical, social and psychological consequences which compromise function and quality of life. Pilocarpine is one treatment for xerostomia. Most studies have shown some variation in individual response to pilocarpine, in terms of dose used, and timing and extent of response.We will determine a population estimate of the efficacy of pilocarpine drops (6 mg) three times daily compared to placebo in relieving dry mouth in palliative care (PC) patients. A secondary aim is to assess individual patients’ response to pilocarpine and provide reports detailing individual response to patients and their treating clinician.Methods/DesignAggregated n-of-1 trials (3 cycle, double blind, placebo-controlled crossover trials using standardized measures of effect). Individual trials will identify which patients respond to the medication. To produce a population estimate of a treatment effect, the results of all cycles will be aggregated.DiscussionManaging dry mouth with treatment supported by the best possible evidence will improve functional status of patients, and improve quality of life for patients and carers. Using n-of-1 trials will accelerate the rate of accumulation of high-grade evidence to support clinical therapies used in PC.Trial registrationAustralia and New Zealand Clinical Trial Registry Number: 12610000840088.

Systematic review of the effectiveness, barriers and facilitators to general practitioner engagement with specialist secondary services in integrated palliative care

The general practitioner (GP) has a critical role in an integrated model of palliative care as they often know the patient and carer well, are experts in generalist care and have knowledge of health and social services in the community. Specialist palliative services have insufficient capacity to meet demand and those with non-cancer terminal conditions and those from rural and remote areas are underserved. Research has focused on improving access to palliative care by engaging the GP with specialist secondary services in integrated palliative care. Objectives (1) Evaluate the effectiveness of interventions designed to engage GPs and specialist secondary services in integrated palliative care; and (2) identify the personal, system and structural barriers and facilitators to integrated palliative care. Method MEDLINE, EMBASE and CINAHL were searched. Any study of a service that engaged the GP with specialist secondary services in the provision of palliative care was included. GP engagement was defined as any organised cooperation between the GP and specialist secondary services in the care of the patient including shared consultations, case conferences that involved at least both the GP and the specialist clinician and/or other secondary services, and/or any formal shared care arrangements between the GP and specialist services. The specialist secondary service is either a specialist palliative service or a service providing specialist care to a palliative population. A narrative framework was used to describe the findings. Results 17 studies were included. There is some evidence that integrated palliative care can reduce hospitalisations and maintain functional status. There are substantial barriers to providing integrated care. Principles and facilitators of the provision of integrated palliative care are discussed. Conclusions This is an emerging field and further research is required assessing the effectiveness of different models of integrated palliative care.

Single-patient multiple crossover studies to determine the effectiveness of paracetamol in relieving pain suffered by patients with advanced cancer taking regular opioids: A pilot study.

What is already known about the topic? Paracetamol is a useful adjunct when used in combination with “weak opioids” for chronic pain in palliative care patients with advanced cancer; however, it is not certain that there is continuing benefit when used in conjunction with “strong” opioids. What this paper adds? N-of-1 trials allowed individual treatment decisions to be made for each participant: there was no added benefit for any of the participants, although no conclusion about the added benefit of paracetamol above regular opioids was possible for the group, due to insufficient numbers recruited. Implications for practice, theory, or policy Paracetamol may not provide added benefit above regular opioids; this should be assessed on a case-by-case basis to justify the extra tablet load.

Testing pilocarpine drops for dry mouth in advanced cancer using n-of-1 trials: A feasibility study:

Background: Dry mouth is a common and troublesome symptom in palliative care. Pilocarpine is a cholinergic agent that promotes salivation. Aim: This study aimed to test the feasibility of using n-of-1 trials to test pilocarpine drops compared to placebo, for patients of palliative care units with advanced cancer, who experienced dry mouth. Design: This was an N-of-1 study, in which each participant was offered three cycles of pilocarpine drops 4% (6 mg tds) (3 days) and placebo drops (3 days) in random order. Setting/participants: Participants were patients of specialist palliative care services with advanced cancer assessed as having a dry mouth, defined as having a score of ⩾3 on an 11-point self-rated xerostomia numerical rating scale, from any cause. Patients self-completed a diary using validated symptom and quality-of-life scores. The randomisation order was unmasked at the end of each person’s trial by a clinician independent of the trial to allow a treatment decisions for individual patients to be made. Results: Nine patients completed at least 1 cycle; 33 cycles of data were completed in total, comprising 438 doses of pilocarpine. Four patients completed the trial: two responded and two did not. Most withdrawals related to deteriorating condition, unacceptable toxicity, non-compliance with study procedures or withdrawal of consent. Many issues contributed to slow recruitment and high withdrawal rate. Conclusion: The formulation of pilocarpine drops proved unacceptable to most participants. More work is required to determine an appropriate formulation, dose and method of delivery and then a retest of pilocarpine drops for this symptom.