RecruitingACTRN12616001269426

Out-of-pocket costs in cancer patients in Sydney, Australia: A pilot study

Sponsor

Concord Repatriation General Hospital

Enrollment

50 participants

Start Date

Jul 14, 2016

Study Type

Observational

Conditions

Cancer out-of-pocket costs financial burden

Summary

This study aims to collect out-of-pocket costs of treatment and management of cancer in patients in three centres in Sydney, Australia. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have a diagnosis of any cancer (early or advanced), are receiving at least one cancer-directed therapy which is expected to continue for at least 3 months, and are under the care of a Medical Oncologist at a centre participating in the study. Study details All participants will complete a questionnaire collecting basic details about their age, income status, sociodemographic details and those of their cancer and it's treatment. They will also complete up to 3 cost diaries which will collect information regarding out-of-pocket costs of their treatment, investigations, appointments, and travel. Participants will grade on a Likert scale how easy to how difficult it was to complete the diaries. Finally, participants will also be required to complete two questionnaires at the end of the three month study period, to evaluate financial distress/toxicity. The information that is collected will help to inform healthcare professionals, patients and government bodies of the costs of cancer treatment and the impact of these costs.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria6

Age greater than or equal to 18 yrs
Diagnosis of malignancy (early or advanced)
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.
Must receive therapy expected to continue for at least 3 months from time of commencing costs’ diary
Must be able to complete a written questionnaire, costs diary, cost-saving strategy and financial toxicity surveys
Must be under the care of a Medical Oncologist at a centre participating in the study

Exclusion Criteria3

Modified Karnofsky scale performance status < 50 i.e. disabled and requiring special care and help.
Inability to comprehend and complete a written questionnaire, costs diary and surveys
Life expectancy of less than 6 months

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Interventions

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

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.