Can the needs of caregivers of patients with advanced cancer be met using a general practitioner (GP) caregiver needs toolkit?
ISRCTN | ISRCTN43614355 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN43614355 |
Secondary identifying numbers | 511168 |
- Submission date
- 03/04/2008
- Registration date
- 01/05/2008
- Last edited
- 23/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Geoffrey Mitchell
Scientific
Scientific
Discipline of General Practice
School of Medicine
University of Queensland
Herston Road
Herston
4006
Australia
Study information
Study design | Multi-centre randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | GP practice |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Can the needs of caregivers of patients with advanced cancer be met using a general practitioner (GP) caregiver needs toolkit? |
Study objectives | 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(s) | Ethics approval received from the University of Queensland Behavioural and Social Sciences Ethical Review Committee on the 26th February 2008 (ref: 2008000206). |
Health condition(s) or problem(s) studied | 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 |
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 study start date | 01/01/2009 |
Completion date | 01/10/2010 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 400, i.e. 200 per group |
Key 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 |
Key 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 |
Date of first enrolment | 01/01/2009 |
Date of final enrolment | 01/10/2010 |
Locations
Countries of recruitment
- Australia
Study participating centre
Discipline of General Practice
Herston
4006
Australia
4006
Australia
Sponsor information
National Health and Medical Research Council (NHMRC) (Australia)
Research council
Research council
GPO Box 1421
Canberra ACT
2601
Australia
Website | http://www.nhmrc.gov.au/ |
---|---|
https://ror.org/011kf5r70 |
Funders
Funder type
Research council
National Health and Medical Research Council (NHMRC) (Australia) (ref: 51168)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NHMRC
- Location
- Australia
Results and Publications
Intention to publish date | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Protocol article | protocol | 29/11/2010 | Yes | No |
Editorial Notes
23/10/2020: Internal review.