PROMISE: Patient Reported Outcome Measures in cancer care: a hybrid effectiveness-Implementation trial to optimise Symptom control and health service Experience

ABSTRACT: Interventions: e-Prom (electronic patient reported outcome measures) comprising of a short questionnaire administered via an electronic platform prior to clinic appointments (during treatment and follow-up) and monthly or as desired by the patient between follow-up appointments. The tools provide information only and thus are not classed as medical devices. It is anticipated that the e-PROM will take 10 minutes to complete, The questionnaires are sent by link via email/SMS and will be self-administered, the links are monitored by research nurse. The overall duration of e-PROM use will be up to 2 years from date of consent. Adherence to intervention is monitored at time of clinical visit, if patient has not completed pre-visit e-Prom the research nurse will assist them to log onto study iPad and complete questionnaire prior to seeing clinician. Primary outcome(s): Physical and functional well-being is a composite primary outcome and is measured by the Physical Wellbeing and Functional subscales of the Functional Assessment of Cancer Treatment - General (FACT-G) scale[At completion of patient treatment and the completion of the patient’s FACT-G questionnaire at 6 months post consent date.];The rate of unplanned hospital presentations/admissions will be treated as a composite outcome. This information will be obtained from hospital records and linkage to Queensland Health Admitted Patients Data Collection (QHAPDC), Emergency Data and Medical Benefits Scheme (MBS) data.[At completion of all patient recruitment and all clinical follow-up and access to data linkage Clinical follow up will occur at baseline (post recruitment) at 12 months and 24 months from date of consent (primary endpoint).] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

DISEASE(S): Cancer-bowel-anal,Cancer-pancreatic,Cancer-lung-small Cell,Cancer-prostate,Cancer-oesophageal (gullet),Cancer-breast,Cancer-head And Neck,Cancer

PROVIDER: 2471505 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR