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

Senior, HEJ; Mitchell, GK; Nikles, J; Carmont, SA; Schluter, PJ; Currow, DC; Vora, R; Yelland, MJ; Agar, M; Good, PD; Hardy, JR

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

Senior, HEJ Mitchell, GK Nikles, J Carmont, SA Schluter, PJ Currow, DC

Vora, R Yelland, MJ Agar, M

Good, PD

Hardy, JR

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Publication Type:: Journal Article
Citation:: BMC Palliative Care, 2013, 12 (1)
Issue Date:: 2013-05-01

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Field	Value	Language
dc.contributor.author	Senior, HEJ	en_US
dc.contributor.author	Mitchell, GK	en_US
dc.contributor.author	Nikles, J	en_US
dc.contributor.author	Carmont, SA	en_US
dc.contributor.author	Schluter, PJ	en_US
dc.contributor.author	Currow, DC https://orcid.org/0000-0003-1988-1250	en_US
dc.contributor.author	Vora, R	en_US
dc.contributor.author	Yelland, MJ	en_US
dc.contributor.author	Agar, M https://orcid.org/0000-0002-6756-6119	en_US
dc.contributor.author	Good, PD https://orcid.org/0000-0002-8198-0375	en_US
dc.contributor.author	Hardy, JR	en_US
dc.date.available	2013-04-16	en_US
dc.date.issued	2013-05-01	en_US
dc.identifier.citation	BMC Palliative Care, 2013, 12 (1)	en_US
dc.identifier.uri	http://hdl.handle.net/10453/115782
dc.description.abstract	Background: It 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/design. This 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. Discussion. This 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 registration. Australian New Zealand Clinical Trials Registry ACTRN12609000794202. © 2013 Senior et al.; licensee BioMed Central Ltd.	en_US
dc.relation.ispartof	BMC Palliative Care	en_US
dc.relation.isbasedon	10.1186/1472-684X-12-17	en_US
dc.subject.classification	Gerontology	en_US
dc.title	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	en_US
dc.type	Journal Article
utslib.citation.volume	1	en_US
utslib.citation.volume	12	en_US
utslib.for	1117 Public Health and Health Services	en_US
utslib.for	1110 Nursing	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/IMPACCT
utslib.copyright.status	in_progress
pubs.issue	1	en_US
pubs.publication-status	Published	en_US
pubs.volume	12	en_US

Abstract:

Background: It 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/design. This 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. Discussion. This 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 registration. Australian New Zealand Clinical Trials Registry ACTRN12609000794202. © 2013 Senior et al.; licensee BioMed Central Ltd.

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http://hdl.handle.net/10453/115782