ANZCTR - Registration

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]

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

Urinary function

Bowel function

Sexual function

Condition category

Condition code

Cancer

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]

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]

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]

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]

Time to complete an effective follow up, assessed by review of the spreadsheet of time (study records)

Timepoint [1]

Time after randomization to collect complete follow up data of patient reported outcomes

Secondary outcome [2]

Direct cost associated with an effective follow up will be assessed after review of the study documents.

Timepoint [2]

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

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]

The Alfred - Prahran

Recruitment hospital [2]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [3]

Cabrini Brighton - Brighton

Recruitment hospital [4]

Masada Private Hospital - East St Kilda

Recruitment hospital [5]

Latrobe Regional Hospital - Traralgon

Recruitment hospital [6]

Peter MacCallum Cancer Institute - East Melbourne

Recruitment hospital [7]

Epworth Eastern Hospital - Box Hill

Recruitment hospital [8]

Epworth Freemasons - Melbourne

Recruitment hospital [9]

Epworth Richmond - Richmond

Recruitment hospital [10]

Barwon Health - Geelong Hospital campus - Geelong

Recruitment hospital [11]

Colac Area Health - Colac

Recruitment hospital [12]

St John of God Hospita, Geelong - Geelong

Recruitment hospital [13]

Geelong Private Hospital - Geelong

Recruitment hospital [14]

Portland District Health - Portland

Recruitment hospital [15]

South West Healthcare - Camperdown - Camperdown

Recruitment hospital [16]

Swan Hill District Health - Swan Hill

Recruitment hospital [17]

Kerang District Health - Kerang

Recruitment hospital [18]

St John of God Hospital - Bendigo - Bendigo

Recruitment hospital [19]

Echuca Regional Health - Echuca

Recruitment hospital [20]

West Gippsland Healthcare Group - Warragul

Recruitment hospital [21]

Mildura Base Hospital - Mildura

Recruitment hospital [22]

Maryvale Private Hospital - Morwell

Recruitment hospital [23]

Mildura Private Hospital - Mildura

Recruitment hospital [24]

Kyneton District Health Service - Kyneton

Recruitment hospital [25]

South Gippsland Hospital - Foster

Recruitment hospital [26]

Bass Coast Regional Health - Wonthaggi

Recruitment hospital [27]

Rochester and Elmore District Health Service - Rochester

Recruitment hospital [28]

Gippsland Southern Health Service - Korumburra campus - Korumburra

Recruitment hospital [29]

Gippsland Southern Health Service - Leongatha campus - Leongatha

Recruitment hospital [30]

Western District Health Service - Coleraine - Coleraine

Recruitment hospital [31]

Western District Health Service - Penshurst - Penshurst

Recruitment hospital [32]

Western District Health Service - Hamilton - Hamilton

Recruitment hospital [33]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [34]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [35]

Caritas Christi Hospice - Kew

Recruitment hospital [36]

Dandenong Hospital - Dandenong

Recruitment hospital [37]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [38]

Monash Medical Centre - Moorabbin campus - East Bentleigh

Recruitment hospital [39]

Angliss Hospital - Upper Ferntree Gully

Recruitment hospital [40]

Box Hill Hospital - Box Hill

Recruitment hospital [41]

Casey Hospital - Berwick

Recruitment hospital [42]

Maroondah Hospital - Ringwood East

Recruitment postcode(s) [1]

3004 - St Kilda Road Central

Recruitment postcode(s) [2]

3084 - Heidelberg

Recruitment postcode(s) [3]

3186 - Brighton

Recruitment postcode(s) [4]

3183 - St Kilda East

Recruitment postcode(s) [5]

3844 - Traralgon

Recruitment postcode(s) [6]

3002 - East Melbourne

Recruitment postcode(s) [7]

3182 - St Kilda

Recruitment postcode(s) [8]

3000 - Melbourne

Recruitment postcode(s) [9]

3121 - Richmond

Recruitment postcode(s) [10]

3220 - Geelong

Recruitment postcode(s) [11]

3250 - Colac

Recruitment postcode(s) [12]

3221 - Geelong

Recruitment postcode(s) [13]

3220 - South Geelong

Recruitment postcode(s) [14]

3305 - Portland

Recruitment postcode(s) [15]

3260 - Camperdown

Recruitment postcode(s) [16]

3585 - Swan Hill

Recruitment postcode(s) [17]

3579 - Kerang

Recruitment postcode(s) [18]

3550 - Bendigo

Recruitment postcode(s) [19]

3564 - Echuca

Recruitment postcode(s) [20]

3820 - Warragul

Recruitment postcode(s) [21]

3500 - Mildura

Recruitment postcode(s) [22]

3840 - Maryvale

Recruitment postcode(s) [23]

3500 - Mildura West

Recruitment postcode(s) [24]

3444 - Kyneton

Recruitment postcode(s) [25]

3960 - Foster

Recruitment postcode(s) [26]

3995 - Wonthaggi

Recruitment postcode(s) [27]

3561 - Rochester

Recruitment postcode(s) [28]

3953 - Leongatha

Recruitment postcode(s) [29]

3953 - Leongatha North

Recruitment postcode(s) [30]

3315 - Coleraine

Recruitment postcode(s) [31]

3289 - Penshurst

Recruitment postcode(s) [32]

3300 - Hamilton

Recruitment postcode(s) [33]

3052 - Parkville

Recruitment postcode(s) [34]

3065 - Fitzroy

Recruitment postcode(s) [35]

3101 - Kew

Recruitment postcode(s) [36]

3175 - Dandenong

Recruitment postcode(s) [37]

3168 - Clayton

Recruitment postcode(s) [38]

3165 - Bentleigh East

Recruitment postcode(s) [39]

3156 - Upper Ferntree Gully

Recruitment postcode(s) [40]

3128 - Box Hill

Recruitment postcode(s) [41]

3806 - Berwick

Recruitment postcode(s) [42]

3135 - Ringwood East

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Monash Partners Academic Health Science Centre (MPAHSC)

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee (MUHREC)

Ethics committee address [1]

Monash University, Room 111, Chancellery Building E
24 Sports Walk, Clayton Campus, Wellington Rd
Clayton VIC 3800, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/11/2015

Approval date [1]

10/11/2015

Ethics approval number [1]

CF15/4157 - 2015001762

Summary

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.

Trial website

Public notes

Contacts

Principal investigator

Name

A/Prof Susan Evans

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

Phone

+61399030017

Email

[email protected]

Contact person for public queries

Name

Dewan Md Emdadul Hoque

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

Phone

+61399030419

Email

[email protected]

Contact person for scientific queries

Name

Dewan Md Emdadul Hoque

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

Phone

+61399030419

Email

[email protected]

Trial Review

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