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Trial registered on ANZCTR


Registration number
ACTRN12616001269426
Ethics application status
Approved
Date submitted
6/09/2016
Date registered
9/09/2016
Date last updated
3/12/2018
Date data sharing statement initially provided
3/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Out-of-pocket costs in cancer patients in Sydney, Australia: A pilot study
Scientific title
Out-of-pocket costs in cancer patients in Sydney, Australia: A pilot study
Secondary ID [1] 290016 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 300035 0
out-of-pocket costs 300036 0
financial burden 300037 0
Condition category
Condition code
Cancer 299930 299930 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
1. Recruitment of participants
A consecutive sample of eligible patients will be recruited for this feasibility study. Patients potentially suitable for the study (age >18 yrs, currently receiving anti-cancer therapy expected to continue for at least 3 months, able to complete a written diary) will be identified upon review of the clinic list by the coordinating investigator, or researcher, and oncologist at the start of the clinic day.

2. Consent
Consent will be obtained by the coordinating investigator or researcher after the study has been introduced to the patient by the treating oncologist.

3. Initial questionnaire
For consenting patients, they will be provided with a questionnaire asking them details regarding their demographics, income level, insurance status etc.
The treating oncologist will be required to complete details pertaining to the patients’ cancer diagnosis and treatment details.

4. Oncologists’ Estimates
The treating oncologist will be requested to complete a form asking to provide a figure of estimated monthly out-of-pocket expense for their patient for cancer-related therapy.

5. Cost Diary
Out-of-pocket costs
The costs diary will be provided on a monthly basis and will ask patients to provide details of:
1. Cancer-related prescription medication (include out-of-pocket cost, reason, money back from insurance/PBS and prescriber)
2. Cancer-related non-prescription medication including complementary and alternative medicines, over-the-counter medication
3. All medication (cancer-related or not, prescribed or over-the-counter) out-of-pocket costs
4. Cancer-related imaging, pathology and doctor’s consultation fees (Medicare Benefits Schedule item number, fee, copayment, refund from health insurance)
5. Travel costs
6. Cancer-related miscellaneous costs including complementary and alternative therapy e.g. massage, aromatherapy, acupuncture etc.
Include out-of-pocket cost, reason, money back from insurance/PBS and prescriber/referrer.

Participants will be asked to complete the monthly cost diary for an overall duration of 3 months.


6. Financial distress/toxicity
Two surveys will be required to be completed by particpants : a financial toxicity COST-PROM survey and a cost-saving strategy survey. The surveys for assessing financial distress will be provided at the end of the three months of the study period.

Intervention code [1] 295735 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299424 0
Feasibility of subjects completing and returning a questionnaire, out-of-pocket costs diary and surveys of financial toxicity and cost-saving strategies for three month period.
This outcome will be assessed based on the following criteria
- 60% of patients that find it easy to complete the cost diary;
- 50% of patients that bring back all 3 monthly out-of-pocket costs diaries;
- 75% of patients that bring back at least one diary.

Questionnaire used:
1.Financial toxicity - COST-PROM survey
This is a non-validated survey that has been used in a previous study and is being developed as a possible tool to assess financial burden. It is currently undergoing validation testing in the Australian population in a separate study currently recruiting participants.

2. Cost-saving strategy survey.
This is a tool used previously in a study conducted in the USA, however has not been used/validated in the Australian setting.
Timepoint [1] 299424 0
At the time of completion of study - three months
Secondary outcome [1] 327117 0
Evaluation of out-of-pocket costs amongst different
- Tumour types
- Health insurance status
- Location of treatment
- Income levels
- Work status
- Comorbid illnesses

This will be assessed using the data collected from the initial questionnaire and cost diaries.
The tool used to collect out-of-pocket costs is a cost diary. This has been designed specifically for this study.
The initial questionnaire, used to collect details of the participant's income, health insurance, social status and cancer treatment, has also been designed specifically for this study.
Timepoint [1] 327117 0
3 months
Secondary outcome [2] 327549 0
Oncologists’ estimates of patients out-of-pocket costs

This will be collected from the oncologists' estimates as collected during the study after patient recruitment.
Timepoint [2] 327549 0
1 month
Secondary outcome [3] 327550 0
Level of Financial toxicity.
This will be assessed using the COST-PROM survey.
Timepoint [3] 327550 0
3 months
Secondary outcome [4] 327551 0
Prevalence of cost-saving strategies.
This will be assessed from the Cost-saving strategy survey.
Timepoint [4] 327551 0
3 months

Eligibility
Key inclusion criteria
Inclusion criteria:
1. Age greater than or equal to 18 yrs
2. Diagnosis of malignancy (early or advanced)
3. Receiving at least one cancer-directed therapy, adjuvant or palliative. This may include intravenous chemotherapy, oral chemotherapy, hormone therapy or targeted therapy. Subjects are allowed to be receiving other forms of cancer-directed therapy including radiotherapy.
4. Must receive therapy expected to continue for at least 3 months from time of commencing costs’ diary
5. Must be able to complete a written questionnaire, costs diary, cost-saving strategy and financial toxicity surveys
6. Must be under the care of a Medical Oncologist at a centre participating in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
1. Modified Karnofsky scale performance status < 50 i.e. disabled and requiring special care and help.
2. Inability to comprehend and complete a written questionnaire, costs diary and surveys
3. Life expectancy of less than 6 months

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This is a feasibility study, so the population size is not relevant. We have selected a sample size of at least 50 participants, as this will allow a broad sampling of patients from different centres, with a variety of cancer streams and treatments.
Patients will be recruited from three centres to allow a broad sample of patients sociodemographically.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
31
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6632 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 6633 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [3] 6634 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment postcode(s) [1] 14253 0
2139 - Concord
Recruitment postcode(s) [2] 14254 0
2050 - Camperdown
Recruitment postcode(s) [3] 14255 0
2200 - Bankstown

Funding & Sponsors
Funding source category [1] 294482 0
Hospital
Name [1] 294482 0
Concord Repatriation General Hospital
Country [1] 294482 0
Australia
Primary sponsor type
Hospital
Name
Concord Repatriation General Hospital
Address
Hospital Road, Concord NSW 2139
Country
Australia
Secondary sponsor category [1] 293349 0
None
Name [1] 293349 0
Address [1] 293349 0
Country [1] 293349 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295919 0
Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 295919 0
Ethics committee country [1] 295919 0
Australia
Date submitted for ethics approval [1] 295919 0
22/02/2016
Approval date [1] 295919 0
29/03/2016
Ethics approval number [1] 295919 0
LNR/16/CRGH/31

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

Contacts
Principal investigator
Name 68554 0
Dr Anupriya Agarwal
Address 68554 0
Department of Medical Oncology
Concord Repatriation General Hospital
Hospital Road, Concord NSW 2139
Country 68554 0
Australia
Phone 68554 0
+61425020228
Fax 68554 0
+61297675764
Email 68554 0
[email protected]
Contact person for public queries
Name 68555 0
Anupriya Agarwal
Address 68555 0
Department of Medical Oncology
Concord Repatriation General Hospital
Hospital Road, Concord NSW 2139
Country 68555 0
Australia
Phone 68555 0
+61297677093
Fax 68555 0
+61297675764
Email 68555 0
[email protected]
Contact person for scientific queries
Name 68556 0
Anupriya Agarwal
Address 68556 0
Department of Medical Oncology
Concord Repatriation General Hospital
Hospital Road, Concord NSW 2139
Country 68556 0
Australia
Phone 68556 0
+61425020228
Fax 68556 0
+61297675764
Email 68556 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.