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

Discipline of General Practice
School of Medicine
University of Queensland
Herston Road
Herston
4006
Australia

Study information

Study designMulti-centre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleCan the needs of caregivers of patients with advanced cancer be met using a general practitioner (GP) caregiver needs toolkit?
Study objectivesThe 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) studiedAdvanced cancer
InterventionOn 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 typeOther
Primary outcome measure1. 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 measures1. 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 date01/01/2009
Completion date01/10/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants400, i.e. 200 per group
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2009
Date of final enrolment01/10/2010

Locations

Countries of recruitment

  • Australia

Study participating centre

Discipline of General Practice
Herston
4006
Australia

Sponsor information

National Health and Medical Research Council (NHMRC) (Australia)
Research council

GPO Box 1421
Canberra ACT
2601
Australia

http://www.nhmrc.gov.au/
ROR logo https://ror.org/011kf5r70

Funders

Funder type

Research council

National Health and Medical Research Council (NHMRC) (Australia) (ref: 51168)
Government organisation / National government
Alternative name(s)
NHMRC
Location
Australia

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.

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