None listed
Conditions
Brief summary
The study is assessing the costs and patient related outcomes associated with chemotherapy delivered at home versus chemotherapy delivered in the hospital setting for breast cancer patients. Who is it for? You may be eligible to join this study if you are a female aged 18 years or above who is scheduled to receive at least four cycles of chemotherapy for breast cancer and are suitable for day-case administration. Study details All participants in this study will receive their first two cycles of chemotherapy in a hospital day unit as per standard care. Provided that the participants do not experience any severe adverse events, they will then be randomly (by chance) allocated to receive their next two chemotherapy cycles either in the hospital day unit or in their home setting. In the home setting, chemotherapy will be administered intravenously by a trained nurse. Your chemotherapy treatment regime will not change. All participants will be asked to complete a number of questionnaires before, during and after chemotherapy treatment in order to evaluate their patient experience, quality of life, anxiety and depression, nausea and vomiting, and treatment safety. Treatment-related costs will also be analysed. It is thought that treatment at home may provide not only a better patient experience, but may deliver a more sustainable health service model of care for the WA Health Department.
Interventions
Therapeutic intervention - at home chemotherapy treatment administered intravenously by a trained nurse. The treatment is as per usual care. For those randomised to the intervention group, cycles 1 and 2 are delivered in the hospital day unit and cycles 3 and 4 are delivered at home. The intervention duration will be 2 x 2 hour (maximum) cycles (cycles 3 and 4).
It is envisaged that most cycles will be 21 days in length. Treatment in most instances will occur on day 1 only, with 20 days until
Therapeutic intervention - at home chemotherapy treatment administered intravenously by a trained nurse. The treatment is as per usual care. For those randomised to the intervention group, cycles 1 and 2 are delivered in the hospital day unit and cycles 3 and 4 are delivered at home. The intervention duration will be 2 x 2 hour (maximum) cycles (cycles 3 and 4). It is envisaged that most cycles will be 21 days in length. Treatment in most instances will occur on day 1 only, with 20 days until the next cycle. Hence, day 1 of the next cycle would be day 22 and so on.
Sponsors
A/Prof Suzanne Robinson
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The inclusion criteria for study participants are: scheduled to receive chemotherapy for breast cancer and suitable for day-case administration; expect to receive at least four cycles of chemotherapy; are aged 18 years or older; WHO performance status of 0,1 or 2, and are able to provide written informed consent. Patients have received two doses of chemotherapy in the hospital-based chemotherapy unit without adverse events prior to enrolment in the study.
Exclusion criteria
Participants who are <18 years old; Those who are unable to give informed consent for any reason; Chemotherapy regimens requiring more than 2 hours administration time; Concurrent uncontrolled medical illness likely to interfere with compliance and a serious adverse event (defined as CTCAE v4 GIII/IV adverse event) during administration of cycles 1 or 2; Patients who suffer either anaphylactic or severe hypersensitivity reaction in the first two cycles of treatment in the hospital day unit; only female patients will be recruited.
Outcome results
None listed