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

INTERVENTION: 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. CONDITION: Breast cancer PRIMARY OUTCOME: Primary outcome 1: Patient experience (Patient Experience Questionnaire) ; Primary Outcome 2: Quality of Life (Functional Assessment of Chronic Illness Therapy Questionnaire FACT‐G version 4) SECONDARY OUTCOME: Secondary outcome 1: Anxiety and depression ‐ (Hospital Anxiety and Depression Scale [HADS]) Secondary outcome 2: Nausea and vomiting ‐ (Multinational Association of Supportive Care in Cancer [MASCC/ Antiemesis Tool) Secondary outcome 3: Safety (Medical Records) Secondary outcome 4: Unplanned admissions (Medical Records) Secondary outcome 5: Total length of time taken to receive treatment ‐ (Interview Tool, specifically designed for this study) Secondary outcome 6: Opinions on waiting times (Interview Tool, specifically designed for this study) Secondary outcome 7: Impact of waiting times ‐ (Interview Tool, specifically designed for this study) Secondary outcome 8: Patient‐related costs ‐ (Interview Tool, specifically designed for this study) 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.