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Trial registered on ANZCTR


Registration number
ACTRN12615001007527
Ethics application status
Approved
Date submitted
2/09/2015
Date registered
28/09/2015
Date last updated
7/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding the role of socioeconomic disadvantage on the needs and experiences of care of cancer patients
Scientific title
Understanding the role of socioeconomic disadvantage on the needs and experiences of care of cancer patients
Secondary ID [1] 287392 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 296095 0
Condition category
Condition code
Cancer 296351 296351 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A survey will be provided to cancer patients to evaluate how socioeconomic factors impact quality of life and experiences of care among cancer patients. Two surveys will be conducted; one at recruitment and one 4 weeks later. A sub-group of at least 15 participants identified as experiencing socioeconomic disadvantage will also complete a telephone interview lasting approximately 15 minutes at 8 weeks post recruitment.
Intervention code [1] 292744 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296003 0
Quality of life as measured by the EORTC QLQ-C30
Timepoint [1] 296003 0
Baseline
Secondary outcome [1] 317200 0
Financial impact of cancer (5 questions). These questions are part of a survey designed specifically for this study.
Timepoint [1] 317200 0
Baseline
Secondary outcome [2] 317202 0
Medication adherence (2 questions). These questions are part of a survey designed specifically for this study.
Timepoint [2] 317202 0
Baseline
Secondary outcome [3] 317203 0
Treatment decision-making (4 questions). These questions are part of a survey designed specifically for this study.
Timepoint [3] 317203 0
Baseline
Secondary outcome [4] 317205 0
Holistic care (3 questions). These questions are part of a survey designed specifically for this study.
Timepoint [4] 317205 0
4 weeks post-recruitment
Secondary outcome [5] 317206 0
Coping skills (6 questions). These questions are part of a survey designed specifically for this study.
Timepoint [5] 317206 0
4 weeks post-recruitment
Secondary outcome [6] 317207 0
Peer Support (4 questions). These questions are part of a survey designed specifically for this study.
Timepoint [6] 317207 0
4 weeks post-recruitment
Secondary outcome [7] 317208 0
Views about life-extending treatment. These questions are part of a survey designed specifically for this study.
Timepoint [7] 317208 0
4 weeks post-recruitment
Secondary outcome [8] 317209 0
Views about palliative chemotherapy (1 question). This question is part of a survey designed specifically for this study.
Timepoint [8] 317209 0
4 weeks post-recruitment
Secondary outcome [9] 317688 0
Discussions about life expectancy (4 questions). These questions are part of a survey designed specifically for this study.
Timepoint [9] 317688 0
Baseline
Secondary outcome [10] 317689 0
Discussions about end of life care (1 question). This question is part of a survey designed specifically for this study.
Timepoint [10] 317689 0
Baseline
Secondary outcome [11] 317692 0
Information provision (3 questions). These questions are part of a survey designed specifically for this study.
Timepoint [11] 317692 0
4 weeks post recruitment
Secondary outcome [12] 317693 0
Doctor-patient communications (2 questions). These questions are part of a survey designed specifically for this study.
Timepoint [12] 317693 0
4 weeks post recruitment
Secondary outcome [13] 317694 0
Co-ordination and continuity of care (4 questions). These questions are part of a survey designed specifically for this study.
Timepoint [13] 317694 0
4 weeks post recruitment
Secondary outcome [14] 317696 0
A composite measure of experiences of cancer care using a series of qualitative questions to identify common themes and issues identified by those experiencing socio-economic disadvantage. These questions were developed specifically for this study.
Timepoint [14] 317696 0
8 weeks post recruitment

Eligibility
Key inclusion criteria
Eligible clients will be those who: (i) are aged 18 years or older; (ii) proficient in English (able to complete the surveys and participate in a telephone interview); iii) have a confirmed diagnosis of cancer (any type), and; iv) attending the clinic for an outpatient medical or radiation oncology appointment. Patients will need to have attended the clinic to receive cancer care on at least one previous occasion in the last 6 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients attending the clinic for the first time or those judged by clinic staff to be too unwell or unable to provide informed consent will be excluded.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/10/2015
Actual
26/10/2015
Date of last participant enrolment
Anticipated
Actual
11/04/2016
Date of last data collection
Anticipated
Actual
19/05/2016
Sample size
Target
300
Accrual to date
Final
525
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4290 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 4291 0
Gosford Hospital - Gosford
Recruitment hospital [3] 4292 0
Orange Health Service - Orange
Recruitment hospital [4] 4375 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [5] 4376 0
Dubbo Base Hospital - Dubbo

Funding & Sponsors
Funding source category [1] 291960 0
Government body
Name [1] 291960 0
Cancer Institute NSW
Country [1] 291960 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive
Callaghan NSW 2308
Australia
Country
Australia
Secondary sponsor category [1] 290625 0
None
Name [1] 290625 0
None
Address [1] 290625 0
None
Country [1] 290625 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293454 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 293454 0
Ethics committee country [1] 293454 0
Australia
Date submitted for ethics approval [1] 293454 0
Approval date [1] 293454 0
12/05/2015
Ethics approval number [1] 293454 0
HREC/15/HNE/128

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59994 0
Prof Rob Sanson-Fisher
Address 59994 0
W4 HMRI Building
University of Newcastle
University Drive
Callaghan, NSW 2308
Country 59994 0
Australia
Phone 59994 0
61240420713
Fax 59994 0
Email 59994 0
[email protected]
Contact person for public queries
Name 59995 0
Heidi Turon
Address 59995 0
W4 HMRI Building
University of Newcastle
University Drive
Callaghan, NSW 2308
Country 59995 0
Australia
Phone 59995 0
61240420694
Fax 59995 0
Email 59995 0
[email protected]
Contact person for scientific queries
Name 59996 0
Rob Sanson-Fisher
Address 59996 0
W4 HMRI Building
University of Newcastle
University Drive
Callaghan, NSW 2308
Country 59996 0
Australia
Phone 59996 0
61240420713
Fax 59996 0
Email 59996 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.