Condition category
Cancer
Date applied
03/04/2008
Date assigned
01/05/2008
Last edited
11/01/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Geoffrey Mitchell

ORCID ID

Contact details

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

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 measures

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

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

http://www.nhmrc.gov.au/

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

Federal/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

Results - basic reporting

Publication summary

1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21114863

Publication citations

  1. 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.

Additional files

Editorial Notes