A randomised controlled trial of breast cancer patients treated with chemotherapy in a hospital day unit or at home; an analysis of cost and patient reported outcomes
- Conditions
- Breast cancerCancer - BreastPublic Health - Health service research
- Registration Number
- ACTRN12615000197538
- Lead Sponsor
- A/Prof Suzanne Robinson
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Female
- Target Recruitment
- 130
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome 1: Patient experience (Patient Experience Questionnaire)<br>[Timepoint Primary Outcome 1 - Patient experience: after fourth treatment cycle<br>];Primary Outcome 2: Quality of Life (Functional Assessment of Chronic Illness Therapy Questionnaire FACT-G version 4)[Timepoint Primary Outcome 2 - Quality of Life: Baseline and after fourth treatment cycle]
- Secondary Outcome Measures
Name Time Method