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Trial registered on ANZCTR


Registration number
ACTRN12615001369516
Ethics application status
Approved
Date submitted
11/12/2015
Date registered
16/12/2015
Date last updated
3/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
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)
Scientific title
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)
Secondary ID [1] 288117 0
Nil Known
Universal Trial Number (UTN)
U1111-1177-4595
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 296989 0
Urinary function 296990 0
Bowel function 296991 0
Sexual function 296992 0
Condition category
Condition code
Cancer 297244 297244 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 293428 0
Other interventions
Comparator / control treatment
This is an equivalence experimental trial. The study was designed to evaluate whether the completeness of survey responses in the 'mail/postal service group' or 'email group' was similar to the 'telephone' group. So we are considering Telephone is the standard method of data collection, hence comparator is the telepone method.
Control group
Active

Outcomes
Primary outcome [1] 296828 0
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.
Timepoint [1] 296828 0
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.
Secondary outcome [1] 319477 0
Time to complete an effective follow up, assessed by review of the spreadsheet of time (study records)
Timepoint [1] 319477 0
Time after randomization to collect complete follow up data of patient reported outcomes
Secondary outcome [2] 319478 0
Direct cost associated with an effective follow up will be assessed after review of the study documents.
Timepoint [2] 319478 0
Cost asssociated with data collection of each methods of data collection for follow up will be assessed at the end of the study

Eligibility
Key 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. .
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
Sample size calculations were based on an equivalence study design and the primary outcome measure (completeness of survey responses). Given the current follow up response rates from the PCOR-VIC we estimate that we will achieve a response rate of 90% when PROMs are administered by the telephone follow-up method. The study was designed to evaluate whether the completeness of survey responses in the 'mail/postal service group' or 'email group' was similar to the 'telephone' group. Assuming that the equivalence margin is 10%, we will require 190 respondents per group. We have made an assumption that those who have Internet access also have an email account. Current data suggest that 83% of households have access to the Internet, so we have assumed that 83% of the respondents have email access. The sample size was adjusted accordingly so the final number of respondents required in each group is 229 giving a total number required n=687. Sample size calculation also assumes that level of significance is at 5%, power 80% and 2-sided test is conducted. The sample size calculation was performed in Stata V13.0
Data analysis plan:
Primary and secondary outcomes
For the primary outcome measure (completeness of surveys) we will estimate individual proportions with 95% CI for each arm of the trial. We will then calculate the pooled sample proportions for each pair and the standard error of the difference. Using these measures we will calculate the Z score test statistics. The p value will be reported for the difference and P<0.05 (80% power) will be considered as statistically significant.
For the secondary outcome measures we will carry out independent sample t-tests to detect the difference at 80% power and 95% CI.
Analysis will be conducted by intention to treat (ITT) as well as per protocol method. The ITT method will allow us to evaluate the effect of each intervention in a real life situation (i.e. when subjects are randomized to the 'email group' but end up in the 'telephone' or ‘mail’ methods instead). The per-protocol method will allow us to study the direct effect of each option.

Economic Analysis
The economic evaluation will consider the costs of personnel resources and supplies, and operating costs as described below. The analysis will not consider development of the PCOR-Vic database, as we consider that this cost will be identical regardless of the data collection modality. However, the additional costs associated with developing the automated email system within the register will be captured.

a. Valuing personnel resources
The value of the research staff contacting patients will be measured in terms of salaries, allowances and benefits received during the study period for their time. At Monash University all personnel maintain a time sheet for their usual activities. We shall calculate time taken for the data collection processes from time sheets for the period of data collection (February 2016-August 2016). As the level of competence required to undertake all tasks are comparable, we will cost the time using a consistent salary across all three groups.

b. Valuing supplies and other recurrent costs
The values of line items like personnel time costs, training costs, envelope, stamp, mail cost, printing costs and telephone costs will be included as variable inputs and valued at the price at which they were obtained. Items obtained free of cost will be valued at market price – that is, the price paid if purchased from the local or international market. If price from the international market is used then that price will be changed in Australian dollars using the purchasing power parity (PPP) of Australian dollar with USD in 2015. The actual expenditure for rent and utilities and supervision during the year will be taken into account. These costs data will be collected from the managers of the data collection facilities using a structured questionnaire.

c. Methodology of time allocation of providers
Data collectors will maintain a spreadsheet to record the time spent for each data collection method (spreadsheet). The time will be categorised into direct data collection and non-service professional activities which includes preparatory activities, maintaining and management of records and information, and obtaining supplies.

d. Calculating Total and Average Costs:
We will sum personnel costs, cost of supplies, training costs and costs of operation and maintenance to provide a total cost for each of the follow up methods as well as average cost for each constituent items.

e. Estimating cost effectiveness
To estimate the most cost-effective approach, incremental cost effectiveness ratios (ICERs) will be estimated. This involves comparing the incremental/additional cost of one approach with the additional outcome achieved by using that approach. Outcome will be measured as completed surveys. The most cost effective approach will be that which achieves the greatest percentage of complete surveys at the least cost. Scenario analysis will be undertaken to test some of the assumptions in estimating the cost of each approach.

Cost projection modelling
A cost projection model will be developed based on most cost-effective approach for collecting completed PROMs surveys. The model will use epidemiological data (Australian prostate cancer incidence data) and the estimated follow-up cost. A sensitivity analysis will be conducted using different follow up rates and cost assumptions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/01/2016
Actual
29/01/2016
Date of last participant enrolment
Anticipated
30/11/2016
Actual
26/11/2016
Date of last data collection
Anticipated
30/11/2016
Actual
26/11/2016
Sample size
Target
1162
Accrual to date
Final
1168
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4874 0
The Alfred - Prahran
Recruitment hospital [2] 4875 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 4876 0
Cabrini Brighton - Brighton
Recruitment hospital [4] 4877 0
Masada Private Hospital - East St Kilda
Recruitment hospital [5] 4878 0
Latrobe Regional Hospital - Traralgon
Recruitment hospital [6] 4879 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [7] 4887 0
Epworth Eastern Hospital - Box Hill
Recruitment hospital [8] 4888 0
Epworth Freemasons - Melbourne
Recruitment hospital [9] 4889 0
Epworth Richmond - Richmond
Recruitment hospital [10] 4890 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [11] 4891 0
Colac Area Health - Colac
Recruitment hospital [12] 4892 0
St John of God Hospita, Geelong - Geelong
Recruitment hospital [13] 4893 0
Geelong Private Hospital - Geelong
Recruitment hospital [14] 4894 0
Portland District Health - Portland
Recruitment hospital [15] 4895 0
South West Healthcare - Camperdown - Camperdown
Recruitment hospital [16] 4896 0
Swan Hill District Health - Swan Hill
Recruitment hospital [17] 4897 0
Kerang District Health - Kerang
Recruitment hospital [18] 4898 0
St John of God Hospital - Bendigo - Bendigo
Recruitment hospital [19] 4899 0
Echuca Regional Health - Echuca
Recruitment hospital [20] 4900 0
West Gippsland Healthcare Group - Warragul
Recruitment hospital [21] 4901 0
Mildura Base Hospital - Mildura
Recruitment hospital [22] 4902 0
Maryvale Private Hospital - Morwell
Recruitment hospital [23] 4903 0
Mildura Private Hospital - Mildura
Recruitment hospital [24] 4904 0
Kyneton District Health Service - Kyneton
Recruitment hospital [25] 4905 0
South Gippsland Hospital - Foster
Recruitment hospital [26] 4906 0
Bass Coast Regional Health - Wonthaggi
Recruitment hospital [27] 4907 0
Rochester and Elmore District Health Service - Rochester
Recruitment hospital [28] 4908 0
Gippsland Southern Health Service - Korumburra campus - Korumburra
Recruitment hospital [29] 4909 0
Gippsland Southern Health Service - Leongatha campus - Leongatha
Recruitment hospital [30] 4910 0
Western District Health Service - Coleraine - Coleraine
Recruitment hospital [31] 4911 0
Western District Health Service - Penshurst - Penshurst
Recruitment hospital [32] 4912 0
Western District Health Service - Hamilton - Hamilton
Recruitment hospital [33] 4913 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [34] 4914 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [35] 4915 0
Caritas Christi Hospice - Kew
Recruitment hospital [36] 4916 0
Dandenong Hospital - Dandenong
Recruitment hospital [37] 4917 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [38] 4918 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [39] 4919 0
Angliss Hospital - Upper Ferntree Gully
Recruitment hospital [40] 4920 0
Box Hill Hospital - Box Hill
Recruitment hospital [41] 4921 0
Casey Hospital - Berwick
Recruitment hospital [42] 4923 0
Maroondah Hospital - Ringwood East
Recruitment postcode(s) [1] 12382 0
3004 - St Kilda Road Central
Recruitment postcode(s) [2] 12383 0
3084 - Heidelberg
Recruitment postcode(s) [3] 12384 0
3186 - Brighton
Recruitment postcode(s) [4] 12385 0
3183 - St Kilda East
Recruitment postcode(s) [5] 12386 0
3844 - Traralgon
Recruitment postcode(s) [6] 12387 0
3002 - East Melbourne
Recruitment postcode(s) [7] 12388 0
3182 - St Kilda
Recruitment postcode(s) [8] 12389 0
3000 - Melbourne
Recruitment postcode(s) [9] 12390 0
3121 - Richmond
Recruitment postcode(s) [10] 12391 0
3220 - Geelong
Recruitment postcode(s) [11] 12392 0
3250 - Colac
Recruitment postcode(s) [12] 12393 0
3221 - Geelong
Recruitment postcode(s) [13] 12394 0
3220 - South Geelong
Recruitment postcode(s) [14] 12395 0
3305 - Portland
Recruitment postcode(s) [15] 12396 0
3260 - Camperdown
Recruitment postcode(s) [16] 12397 0
3585 - Swan Hill
Recruitment postcode(s) [17] 12398 0
3579 - Kerang
Recruitment postcode(s) [18] 12399 0
3550 - Bendigo
Recruitment postcode(s) [19] 12400 0
3564 - Echuca
Recruitment postcode(s) [20] 12401 0
3820 - Warragul
Recruitment postcode(s) [21] 12402 0
3500 - Mildura
Recruitment postcode(s) [22] 12403 0
3840 - Maryvale
Recruitment postcode(s) [23] 12405 0
3500 - Mildura West
Recruitment postcode(s) [24] 12406 0
3444 - Kyneton
Recruitment postcode(s) [25] 12407 0
3960 - Foster
Recruitment postcode(s) [26] 12408 0
3995 - Wonthaggi
Recruitment postcode(s) [27] 12409 0
3561 - Rochester
Recruitment postcode(s) [28] 12412 0
3953 - Leongatha
Recruitment postcode(s) [29] 12413 0
3953 - Leongatha North
Recruitment postcode(s) [30] 12414 0
3315 - Coleraine
Recruitment postcode(s) [31] 12415 0
3289 - Penshurst
Recruitment postcode(s) [32] 12416 0
3300 - Hamilton
Recruitment postcode(s) [33] 12417 0
3052 - Parkville
Recruitment postcode(s) [34] 12418 0
3065 - Fitzroy
Recruitment postcode(s) [35] 12419 0
3101 - Kew
Recruitment postcode(s) [36] 12420 0
3175 - Dandenong
Recruitment postcode(s) [37] 12421 0
3168 - Clayton
Recruitment postcode(s) [38] 12422 0
3165 - Bentleigh East
Recruitment postcode(s) [39] 12424 0
3156 - Upper Ferntree Gully
Recruitment postcode(s) [40] 12425 0
3128 - Box Hill
Recruitment postcode(s) [41] 12426 0
3806 - Berwick
Recruitment postcode(s) [42] 12427 0
3135 - Ringwood East

Funding & Sponsors
Funding source category [1] 292539 0
Government body
Name [1] 292539 0
Monash Partners Academic Health Science Centre (MPAHSC)
Country [1] 292539 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Epidemiology and Preventive Medicine (DEPM)
School of Public Health and Preventive Medicine, Monash University, The Alfred Centre, Level 6, 99 Commercial Road, Melbourne, VIC, Australia 3004
Country
Australia
Secondary sponsor category [1] 291276 0
None
Name [1] 291276 0
Address [1] 291276 0
Country [1] 291276 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294013 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 294013 0
Ethics committee country [1] 294013 0
Australia
Date submitted for ethics approval [1] 294013 0
02/11/2015
Approval date [1] 294013 0
10/11/2015
Ethics approval number [1] 294013 0
CF15/4157 - 2015001762

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62110 0
A/Prof Susan Evans
Address 62110 0
Department of Epidemiology and Preventive Medicine (DEPM)
School of Public Health and Preventive Medicine, Monash University, The Alfred Centre, Level 6, 99 Commercial Road, Melbourne, VIC, Australia 3004
Country 62110 0
Australia
Phone 62110 0
+61399030017
Fax 62110 0
+61399030556
Email 62110 0
[email protected]
Contact person for public queries
Name 62111 0
Dewan Md Emdadul Hoque
Address 62111 0
Department of Epidemiology and Preventive Medicine (DEPM)
School of Public Health and Preventive Medicine, Monash University, The Alfred Centre, Level 6, 99 Commercial Road, Melbourne, VIC, Australia 3004
Country 62111 0
Australia
Phone 62111 0
+61399030419
Fax 62111 0
+61399030556
Email 62111 0
[email protected]
Contact person for scientific queries
Name 62112 0
Dewan Md Emdadul Hoque
Address 62112 0
Department of Epidemiology and Preventive Medicine (DEPM)
School of Public Health and Preventive Medicine, Monash University, The Alfred Centre, Level 6, 99 Commercial Road, Melbourne, VIC, Australia 3004
Country 62112 0
Australia
Phone 62112 0
+61399030419
Fax 62112 0
+61399030556
Email 62112 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No additional documents have been identified.