Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
511168
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Ethics approval received from the University of Queensland Behavioural and Social Sciences Ethical Review Committee on the 26th February 2008 (ref: 2008000206).
Study design
Multi-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Advanced cancer
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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.
Secondary outcome measures
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.
Overall trial start date
01/01/2009
Overall trial end date
01/10/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400, i.e. 200 per group
Participant exclusion criteria
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
Recruitment start date
01/01/2009
Recruitment end date
01/10/2010
Locations
Countries of recruitment
Australia
Trial participating centre
Discipline of General Practice
Herston
4006
Australia
Sponsor information
Organisation
National Health and Medical Research Council (NHMRC) (Australia)
Sponsor details
GPO Box 1421
Canberra ACT
2601
Australia
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
National Health and Medical Research Council (NHMRC) (Australia) (ref: 51168)
Alternative name(s)
NHMRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Australia
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21114863
Publication citations
-
Protocol
Mitchell G, Girgis A, Jiwa M, Sibbritt D, Burridge L, A GP Caregiver Needs Toolkit versus usual care in the management of the needs of caregivers of patients with advanced cancer: a randomized controlled trial., Trials, 2010, 11, 115, doi: 10.1186/1745-6215-11-115.