ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cancer

Condition category

Condition code

Cancer

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]

Not applicable

Comparator / control treatment

Not applicable

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Quality of life as measured by the EORTC QLQ-C30

Timepoint [1]

Baseline

Secondary outcome [1]

Financial impact of cancer (5 questions). These questions are part of a survey designed specifically for this study.

Timepoint [1]

Baseline

Secondary outcome [2]

Medication adherence (2 questions). These questions are part of a survey designed specifically for this study.

Timepoint [2]

Baseline

Secondary outcome [3]

Treatment decision-making (4 questions). These questions are part of a survey designed specifically for this study.

Timepoint [3]

Baseline

Secondary outcome [4]

Holistic care (3 questions). These questions are part of a survey designed specifically for this study.

Timepoint [4]

4 weeks post-recruitment

Secondary outcome [5]

Coping skills (6 questions). These questions are part of a survey designed specifically for this study.

Timepoint [5]

4 weeks post-recruitment

Secondary outcome [6]

Peer Support (4 questions). These questions are part of a survey designed specifically for this study.

Timepoint [6]

4 weeks post-recruitment

Secondary outcome [7]

Views about life-extending treatment. These questions are part of a survey designed specifically for this study.

Timepoint [7]

4 weeks post-recruitment

Secondary outcome [8]

Views about palliative chemotherapy (1 question). This question is part of a survey designed specifically for this study.

Timepoint [8]

4 weeks post-recruitment

Secondary outcome [9]

Discussions about life expectancy (4 questions). These questions are part of a survey designed specifically for this study.

Timepoint [9]

Baseline

Secondary outcome [10]

Discussions about end of life care (1 question). This question is part of a survey designed specifically for this study.

Timepoint [10]

Baseline

Secondary outcome [11]

Information provision (3 questions). These questions are part of a survey designed specifically for this study.

Timepoint [11]

4 weeks post recruitment

Secondary outcome [12]

Doctor-patient communications (2 questions). These questions are part of a survey designed specifically for this study.

Timepoint [12]

4 weeks post recruitment

Secondary outcome [13]

Co-ordination and continuity of care (4 questions). These questions are part of a survey designed specifically for this study.

Timepoint [13]

4 weeks post recruitment

Secondary outcome [14]

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]

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?

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]

Liverpool Hospital - Liverpool

Recruitment hospital [2]

Gosford Hospital - Gosford

Recruitment hospital [3]

Orange Health Service - Orange

Recruitment hospital [4]

Campbelltown Hospital - Campbelltown

Recruitment hospital [5]

Dubbo Base Hospital - Dubbo

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Cancer Institute NSW

Address [1]

Australian Technology Park
Level 9, 8 Central Avenue
EVELEIGH NSW 2015
AUSTRALIA

Country [1]

Australia

Primary sponsor type

University

Name

The University of Newcastle

Address

University Drive
Callaghan NSW 2308
Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

Hunter New England Local Health District
Locked Bag 1
New Lambton NSW 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

12/05/2015

Ethics approval number [1]

HREC/15/HNE/128

Summary

Brief summary

The primary purpose of this study is to evaluate the role of socioeconomic disadvantage on the needs and experiences of care of cancer patients. Australians experiencing socioeconomic disadvantage have poorer cancer-related outcomes than their counterparts. To ensure cancer care is equitable it is imperative that steps are taken to reduce disparities in care related to socioeconomic status. However, in order to achieve this aim and to make improvements where they are most needed, we must first understand where the greatest disparities in cancer care exist. Who is it for? You may be eligible to join this study if you are aged 18 or over, have been diagnosed with any form of cancer, are attending the clinic for an outpatient medical or radiation oncology appointment at any of the recruitment hospitals and have attended the clinic on at least one previous occasion in the last 6 months. Study details All participants recruited to this study will be asked to complete a survey while waiting for their outpatient appointment. A follow-up survey will be mailed to participants 4 weeks post-recruitment. Surveys will contain questions relating to patients' experiences with cancer care, quality of life, socio-demographics, disease and treatment related characteristics will also be included. A sub-sample of at least 15 participants whose survey responses indicate they are experiencing socioeconomic disadvantage, will also be contacted by the research team 8 weeks post-recruitment to participate in a telephone interview. This study will help to identify the gaps in care for cancer patients experiencing socioeconomic disadvantage, which may assist in informing the Cancer Institute NSW as to which specific areas should be targeted to improve care for this vulnerable population.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Rob Sanson-Fisher

Address

W4 HMRI Building
University of Newcastle
University Drive
Callaghan, NSW 2308

Country

Australia

Phone

61240420713

Fax

[email protected]

Contact person for public queries

Name

Heidi Turon

Address

W4 HMRI Building
University of Newcastle
University Drive
Callaghan, NSW 2308

Country

Australia

Phone

61240420694

Fax

[email protected]

Contact person for scientific queries

Name

Rob Sanson-Fisher

Address

W4 HMRI Building
University of Newcastle
University Drive
Callaghan, NSW 2308

Country

Australia

Phone

61240420713

Fax

[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.

Trial Review

Documents added manually

Documents added automatically