RCT to evaluate effectiveness of telephone, mail or email approaches to collecting Patient Reported Outcome Measures (PROMs) data using Prostate Cancer Outcomes Registry-Victoria (PCOR-VIC)

ABSTRACT: Interventions: Description of intervention(s) / exposure: Men who are diagnosed with prostate cancer and who have consented to contributing data to the Prostate Cancer Outcomes Registry Victoria (PCOR-VIC) will be eligible to participate in this project. Three different methods of Patient Reported Outcome Measures (PROMs) data collection by telephone or mail or email will be introduced to assess the quality of life of prostate cancer patients using EPIC -26 tools. Details of each of the three different interventions are described below: Men are contacted to confirm that clinical data are accurate and up-to-date and to collect PROMS using the validated EPIC-26 quality of life instrument. Contact is made any time within a window period of 21 days either side of the anniversary date for data collection (henceforth recorded as the Anniversary Date”). This is 12 months from the date of the positive biopsy for patients who do not proceed to active treatment or only receive androgen deprivation therapy; or 12 months from the date on which final initial treatment, or course of treatment, finished. For surgery and low-dose rate (seed) brachytherapy, this is the date of the procedure. For radiotherapy and chemotherapy it is the date that the last dose of therapy was provided; for radiotherapy this is usually six weeks after radiotherapy was commenced and for chemotherapy this is usually 12 months after treatment commenced. Intervention A: PROMs data collection by follow up data collectors over the telephone 1.An attempt to contact patients via phone will be made up until 21 days post diagnosis/treatment. Approximately each day a data collector will make one attempt to contact the patient 2.Patients responding will have PROMS entered directly to the PCOR-VIC web system Primary outcome(s): The primary outcome of interest will be effective successful follow up. Effective successful follow up is defined as providing a response to each of the 26 questions in the survey. A valid response might be that the patient declines to answer a question. [After randomization any time within a window period of 21 days either side of the anniversary date for data collection. Anniversary data is 12 months from the date of the positive biopsy for patients who do not proceed to active treatment or only receive androgen deprivation therapy; or 12 months from the date on which final initial treatment, or course of treatment, finished. For surgery and low-dose rate (seed) brachytherapy, this is the date of the procedure. For radiotherapy and chemotherapy this is the date that the last dose of therapy was provided. ] Study Design: Purpose: Diagnosis; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy

DISEASE(S): Sexual Function,Bowel Function,Cancer-prostate,Prostate Cancer,Urinary Function

PROVIDER: 2463039 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR