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Protocol for the Care-IS Trial: a randomised controlled trial of a supportive educational intervention for carers of patients with high-grade glioma (HGG)
High-grade glioma (HGG) is a rapidly progressive and debilitating disease. Primary carers experience significant levels of distress which impacts on their experience of caregiving, the quality of care received and the community in terms of the increased reliance on healthcare due to the potential de...
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| Published in: | BMJ open 2015-10, Vol.5 (10), p.e009477-e009477 |
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| creator | Halkett, Georgia K B Lobb, Elizabeth A Miller, Lisa Phillips, Jane L Shaw, Thérése Moorin, Rachael Long, Anne King, Anne Clarke, Jenny Fewster, Stephanie Hudson, Peter Agar, Meera Nowak, Anna K |
| description | High-grade glioma (HGG) is a rapidly progressive and debilitating disease. Primary carers experience significant levels of distress which impacts on their experience of caregiving, the quality of care received and the community in terms of the increased reliance on healthcare due to the potential development of complicated grief. This paper describes the protocol for testing the efficacy and feasibility of an intervention for primary carers of patients with HGG in order to improve preparedness to care and reduce carer distress.
Randomised controlled trial. The target population is carers of patients with HGG who are undergoing combined chemoradiotherapy. The intervention consists of 4 components: (1) initial telephone assessment of unmet needs of the carer, (2) tailoring of a personalised resource folder, (3) home visit, (4) ongoing monthly telephone contact and support for 12 months. The control arm will receive usual care.
This intervention will improve preparedness for caring and reduce carer psychological distress.
This intervention will reduce carer unmet needs. The longer term aim of the intervention is to reduce patient healthcare resource utilisation and, by doing so, reduce costs. Assessments will be obtained at baseline, 8 weeks post intervention, then 4, 6 and 12 months. Participants will also complete a healthcare utilisation checklist and proxy performance status which will be assessed at baseline and monthly. 240 carers will be recruited. The sample size is 180. Multilevel mixed effects regression models will be applied to test the effect of the intervention.
Ethics approval has been gained from Curtin University and the participating sites.
Results will be reported in international peer-reviewed journals.
Australian and New Zealand Clinical Trials Registration (ACTRN)12612001147875. |
| doi_str_mv | 10.1136/bmjopen-2015-009477 |
| format | article |
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Randomised controlled trial. The target population is carers of patients with HGG who are undergoing combined chemoradiotherapy. The intervention consists of 4 components: (1) initial telephone assessment of unmet needs of the carer, (2) tailoring of a personalised resource folder, (3) home visit, (4) ongoing monthly telephone contact and support for 12 months. The control arm will receive usual care.
This intervention will improve preparedness for caring and reduce carer psychological distress.
This intervention will reduce carer unmet needs. The longer term aim of the intervention is to reduce patient healthcare resource utilisation and, by doing so, reduce costs. Assessments will be obtained at baseline, 8 weeks post intervention, then 4, 6 and 12 months. Participants will also complete a healthcare utilisation checklist and proxy performance status which will be assessed at baseline and monthly. 240 carers will be recruited. The sample size is 180. Multilevel mixed effects regression models will be applied to test the effect of the intervention.
Ethics approval has been gained from Curtin University and the participating sites.
Results will be reported in international peer-reviewed journals.
Australian and New Zealand Clinical Trials Registration (ACTRN)12612001147875.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2015-009477</identifier><identifier>PMID: 26503395</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Activities of daily living ; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Australia ; Brain cancer ; Brain research ; Cancer therapies ; Caregivers ; Caregivers - education ; Caregivers - psychology ; Clinical Protocols ; Costs and Cost Analysis ; Disease ; Education ; Female ; Glioma ; Glioma - nursing ; Health Care Costs ; House Calls ; Humans ; Illnesses ; Intervention ; Male ; Medical prognosis ; Middle Aged ; New Zealand ; Oncology ; Palliative care ; Patients ; Personality ; Prospective Studies ; Quality of life ; Quality of Life - psychology ; Research Design ; Stress ; Young Adult</subject><ispartof>BMJ open, 2015-10, Vol.5 (10), p.e009477-e009477</ispartof><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ 2015 This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ 2015</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c433t-d16cbbfb140dfa45d1afb61f38bc342572e86d04dd72499fed4c22b7af66e2953</citedby><cites>FETCH-LOGICAL-c433t-d16cbbfb140dfa45d1afb61f38bc342572e86d04dd72499fed4c22b7af66e2953</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/2663394240/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2663394240?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,3180,25732,27903,27904,36991,36992,44569,53769,53771,74872</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26503395$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Halkett, Georgia K B</creatorcontrib><creatorcontrib>Lobb, Elizabeth A</creatorcontrib><creatorcontrib>Miller, Lisa</creatorcontrib><creatorcontrib>Phillips, Jane L</creatorcontrib><creatorcontrib>Shaw, Thérése</creatorcontrib><creatorcontrib>Moorin, Rachael</creatorcontrib><creatorcontrib>Long, Anne</creatorcontrib><creatorcontrib>King, Anne</creatorcontrib><creatorcontrib>Clarke, Jenny</creatorcontrib><creatorcontrib>Fewster, Stephanie</creatorcontrib><creatorcontrib>Hudson, Peter</creatorcontrib><creatorcontrib>Agar, Meera</creatorcontrib><creatorcontrib>Nowak, Anna K</creatorcontrib><title>Protocol for the Care-IS Trial: a randomised controlled trial of a supportive educational intervention for carers of patients with high-grade glioma (HGG)</title><title>BMJ open</title><addtitle>BMJ Open</addtitle><description>High-grade glioma (HGG) is a rapidly progressive and debilitating disease. Primary carers experience significant levels of distress which impacts on their experience of caregiving, the quality of care received and the community in terms of the increased reliance on healthcare due to the potential development of complicated grief. This paper describes the protocol for testing the efficacy and feasibility of an intervention for primary carers of patients with HGG in order to improve preparedness to care and reduce carer distress.
Randomised controlled trial. The target population is carers of patients with HGG who are undergoing combined chemoradiotherapy. The intervention consists of 4 components: (1) initial telephone assessment of unmet needs of the carer, (2) tailoring of a personalised resource folder, (3) home visit, (4) ongoing monthly telephone contact and support for 12 months. The control arm will receive usual care.
This intervention will improve preparedness for caring and reduce carer psychological distress.
This intervention will reduce carer unmet needs. The longer term aim of the intervention is to reduce patient healthcare resource utilisation and, by doing so, reduce costs. Assessments will be obtained at baseline, 8 weeks post intervention, then 4, 6 and 12 months. Participants will also complete a healthcare utilisation checklist and proxy performance status which will be assessed at baseline and monthly. 240 carers will be recruited. The sample size is 180. Multilevel mixed effects regression models will be applied to test the effect of the intervention.
Ethics approval has been gained from Curtin University and the participating sites.
Results will be reported in international peer-reviewed journals.
Australian and New Zealand Clinical Trials Registration (ACTRN)12612001147875.</description><subject>Activities of daily living</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Australia</subject><subject>Brain cancer</subject><subject>Brain research</subject><subject>Cancer therapies</subject><subject>Caregivers</subject><subject>Caregivers - education</subject><subject>Caregivers - psychology</subject><subject>Clinical Protocols</subject><subject>Costs and Cost Analysis</subject><subject>Disease</subject><subject>Education</subject><subject>Female</subject><subject>Glioma</subject><subject>Glioma - nursing</subject><subject>Health Care Costs</subject><subject>House Calls</subject><subject>Humans</subject><subject>Illnesses</subject><subject>Intervention</subject><subject>Male</subject><subject>Medical prognosis</subject><subject>Middle Aged</subject><subject>New Zealand</subject><subject>Oncology</subject><subject>Palliative care</subject><subject>Patients</subject><subject>Personality</subject><subject>Prospective Studies</subject><subject>Quality of life</subject><subject>Quality of Life - 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Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMJ open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Halkett, Georgia K B</au><au>Lobb, Elizabeth A</au><au>Miller, Lisa</au><au>Phillips, Jane L</au><au>Shaw, Thérése</au><au>Moorin, Rachael</au><au>Long, Anne</au><au>King, Anne</au><au>Clarke, Jenny</au><au>Fewster, Stephanie</au><au>Hudson, Peter</au><au>Agar, Meera</au><au>Nowak, Anna K</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Protocol for the Care-IS Trial: a randomised controlled trial of a supportive educational intervention for carers of patients with high-grade glioma (HGG)</atitle><jtitle>BMJ open</jtitle><addtitle>BMJ Open</addtitle><date>2015-10-26</date><risdate>2015</risdate><volume>5</volume><issue>10</issue><spage>e009477</spage><epage>e009477</epage><pages>e009477-e009477</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>High-grade glioma (HGG) is a rapidly progressive and debilitating disease. Primary carers experience significant levels of distress which impacts on their experience of caregiving, the quality of care received and the community in terms of the increased reliance on healthcare due to the potential development of complicated grief. This paper describes the protocol for testing the efficacy and feasibility of an intervention for primary carers of patients with HGG in order to improve preparedness to care and reduce carer distress.
Randomised controlled trial. The target population is carers of patients with HGG who are undergoing combined chemoradiotherapy. The intervention consists of 4 components: (1) initial telephone assessment of unmet needs of the carer, (2) tailoring of a personalised resource folder, (3) home visit, (4) ongoing monthly telephone contact and support for 12 months. The control arm will receive usual care.
This intervention will improve preparedness for caring and reduce carer psychological distress.
This intervention will reduce carer unmet needs. The longer term aim of the intervention is to reduce patient healthcare resource utilisation and, by doing so, reduce costs. Assessments will be obtained at baseline, 8 weeks post intervention, then 4, 6 and 12 months. Participants will also complete a healthcare utilisation checklist and proxy performance status which will be assessed at baseline and monthly. 240 carers will be recruited. The sample size is 180. Multilevel mixed effects regression models will be applied to test the effect of the intervention.
Ethics approval has been gained from Curtin University and the participating sites.
Results will be reported in international peer-reviewed journals.
Australian and New Zealand Clinical Trials Registration (ACTRN)12612001147875.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>26503395</pmid><doi>10.1136/bmjopen-2015-009477</doi><oa>free_for_read</oa></addata></record> |
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| source | BMJ; Publicly Available Content Database; PubMed Central; British Medical Journal Open Access Journals |
| subjects | Activities of daily living Adolescent Adult Aged Aged, 80 and over Australia Brain cancer Brain research Cancer therapies Caregivers Caregivers - education Caregivers - psychology Clinical Protocols Costs and Cost Analysis Disease Education Female Glioma Glioma - nursing Health Care Costs House Calls Humans Illnesses Intervention Male Medical prognosis Middle Aged New Zealand Oncology Palliative care Patients Personality Prospective Studies Quality of life Quality of Life - psychology Research Design Stress Young Adult |
| title | Protocol for the Care-IS Trial: a randomised controlled trial of a supportive educational intervention for carers of patients with high-grade glioma (HGG) |
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