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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)

An equivalence randomized controlled trial to evaluate the effectiveness of three different approaches to collecting Patient Reported Outcome Measures (PROMs) data using the Prostate Cancer Outcomes Registry-Victoria (PCOR-VIC)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615001369516
Enrollment
1168
Registered
2015-12-16
Start date
2016-01-29
Completion date
2016-11-26
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study was designed to conduct an equivalence experimental trial adopting a randomized control design. The participants will be individually randomized to three independent groups, email or postal or telephone. Number of respondents required in each group is 229 and total number required n=687. The study was designed with overall aim to conduct a effectiveness analysis of three different methods of data collection; email, postal and telephone. 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 and secondary objectives are to: a. Estimate recurrent costs of data collection using telephone, postal services/mail and electronic mail (email) for PROMs data in PCOR-VIC b.Compare the cost-effectiveness of the three different methods of data collection. c. Develop a cost projection model to estimate the cost for nation-wide scale-up of administering the PROMs data collection tool in the most efficient setting for follow up of prostate cancer patients in Australia. To collect costing data ABC (Activity Based Costs) method will be adopted and data will be collected through structured questionnaire. Cost data will be collected from provider perspective. A model will be developed based on most cost-effectiveness approach to determine the cost for national scale up. The main outcome of interest will be effective successful follow up. Secondary outcome measures will also include time to complete an effective follow up and direct costing associated with an effective follow up. This study will provide an opportunity to identify the most cost-effective approach for completed follow up of prostate cancer patients by using EPIC-26 tool. This will be important for many registries which are currently collecting data from patients. Moreover, we expect that the findings of this study will help us to understand the cost for national scale up.

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 interve

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 3. Patients will be considered lost to follow up if they do not respond after 21 days from 12 month Anniversary Date. Intervention B: Data collection by follow up data collectors by mail (postal service) 1. The EPIC-26 survey will be mailed to patients if they are contacted any time from 21 days before, up to and including, the Anniversary Date. The survey will be accompanied with a personalised, signed letter with instructions and a postage-paid, self-addressed envelope; 2. If the survey is not returned by 14 days post the Anniversary Date, patients will be telephoned as per Intervention A. Data collector will make one attempt each day i.e 14 attempts in total. 3. Lost to follow up – refer to Step 3 of Intervention A. Intervention C: Data collection by E-mail link to online survey 1. If email is not available then the participants will randomly assign to either telephone (intervention A) or mail (Intervention B). 2. In this method, a Uniform Resource Locator (URL) which is the address of a web page link to the EPIC-26 survey will be emailed to participants if they are contacted any time from 21 days before, up to and including, the Anniversary Date. 3. If participants do not complete the online survey by 14 days post the Anniversary Date, patients will be telephoned as per Intervention A. Data collector will make one attempt each day i.e 14 attempts in total. 4. Lost to follow up – refer to Step 3 of Intervention A.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Men will be eligible to participate in this study if they are aged >18 years, have a confirmed diagnosis of prostate cancer, have not opted off the registry and answer the telephone when contacted by data collectors in the 21 days leading up to and including their 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. .

Exclusion criteria

Men will be ineligible for inclusion in the RCT(1) if they opt off the registry; (2) if they have died; (3)they do not speak English; or ( 4) if they have been diagnosed by Transurethral Resection of the Prostate (TURP) and their treating doctor has requested that we not contact them for follow up; or if they answer the telephone after their Anniversary Date.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 27, 2026