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ISRCTN
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ISRCTN43614355
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ClinicalTrials.gov identifier
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Public title
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Can the needs of caregivers of patients with advanced cancer be met using a general practitioner (GP) caregiver needs toolkit?
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Scientific title
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Acronym
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N/A
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Serial number at source
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511168
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Study hypothesis
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The number and levels of unmet needs of caregivers of patients with advanced cancer will be significantly lower in caregivers whose needs are systematically assessed using a needs assessment tool and then addressed by their general practitioner (GP), compared with caregivers receiving usual care.
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Ethics approval
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Ethics approval received from the University of Queensland Behavioural and Social Sciences Ethical Review Committee on the 26th February 2008 (ref: 2008000206).
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Study design
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Multi-centre randomised controlled trial
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Countries of recruitment
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Australia
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Disease/condition/study domain
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Advanced cancer
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Participants - inclusion criteria
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1. Nominated caregiver of a patient with a diagnosis of advanced cancer, i.e. no longer amenable to cure, with either extensive local or regional spread or metastatic disease
2. Aged 18 years or older, either sex
3. Able to understand English sufficiently to complete questionnaires and telephone interviews
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Participants - exclusion criteria
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1. Caregivers of cancer patients with a prognosis of greater than 12 months
2. Cognitively unable to give consent or unable to understand and respond to questions in English
3. Younger than 18 years of age
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Anticipated start date
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01/01/2009
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Anticipated end date
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01/10/2010
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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400, i.e. 200 per group
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Interventions
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On recruitment, caregivers will be randomised off-site into the intervention or control group using computer-generated random number tables.
Intervention group:
The caregiver needs assessment tool (C-NAT) will be developed in the next six months. It will assess caregivers' unmet needs across a number of domains including their physical and psychological wellbeing, spiritual, existential, social, financial and legal needs, and bereavement grief. To evaluate caregivers' needs and the effectiveness of the C-NAT, participants will be surveyed using computer-assisted telephone interviews at four time-points over a six-month period: as soon as possible after recruitment, then at one month, three months and six months. We anticipate that each interview will take approximately 40 minutes. Prior to the first interview, intervention group caregivers will receive a copy of the C-NAT and the interview questions, for reference during each telephone interview. At the end of the first interview, caregivers will be asked to rate their levels of needs and to attend their GP to discuss these, preferably between one and two weeks from the interview, so that the GP can be briefed regarding the study materials. Caregivers will complete the C-NAT again after the three-month interview and visit their GP to discuss. The identified needs of intervention caregivers will be assessed and managed through a specifically developed general practice-based strategy.
Control group:
Caregivers in the control group will receive usual care, i.e. they will be surveyed regarding their needs via phone interviews only; they will have no awareness or involvement with the C-NAT nor will they be asked to visit their GP.
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Primary outcome measure(s)
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1. Reduced number and levels of unmet needs reported by caregivers
2. Demonstrated acceptability of the intervention for GPs
The primary outcome will be a difference of 0.9 to 1.4 units in intervention group carers' anxiety and depression scores over six months.
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Secondary outcome measure(s)
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1. Reduced number and levels of unmet needs reported by caregivers
2. Demonstrated acceptability of the intervention for GPs
The secondary outcomes will be the results for these measures at one month and three months.
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Sources of funding
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National Health and Medical Research Council (NHMRC) (Australia) (ref: 51168)
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Trial website
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Publications
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Contact name
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Prof
Geoffrey
Mitchell
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Address
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Discipline of General Practice
School of Medicine
University of Queensland
Herston Road
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City/town
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Herston
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Zip/Postcode
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4006
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Country
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Australia
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Sponsor
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National Health and Medical Research Council (NHMRC) (Australia)
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Address
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GPO Box 1421
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City/town
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Canberra ACT
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Zip/Postcode
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2601
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Country
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Australia
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Sponsor website:
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http://www.nhmrc.gov.au/
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Date applied
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03/04/2008
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Last edited
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01/05/2008
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Date ISRCTN assigned
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01/05/2008
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