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Trial registered on ANZCTR


Registration number
ACTRN12615000932561
Ethics application status
Approved
Date submitted
26/08/2015
Date registered
7/09/2015
Date last updated
28/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of online versus telephone-based information and support: Can electronic platforms deliver effective care for lung cancer patients?
Scientific title
Do lung cancer patients who receive telephone or on-line support have better wellbeing outcomes than those who receive a booklet only
Secondary ID [1] 287320 0
Nil
Universal Trial Number (UTN)
Trial acronym
OPAL
On-line and Phone Assistance for Lung cancer patients
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer 295957 0
Condition category
Condition code
Cancer 296230 296230 0 0
Lung - Mesothelioma
Cancer 296231 296231 0 0
Lung - Non small cell
Cancer 296232 296232 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental group A: Proactive Telephone Delivered Support.
Patients will receive a 10-50 minute outbound call from a trained Helpline consultant. The Helpline consultant will also offer an additional, subsequent call-out. Following the completion of the two proactive calls from the Helpline, patients in this group can initiate further contact with the CCNSW Helpline if desired. While most contact is concluded within 3 months, there is no time limit on contact with the Helpline.
Call content will reflect usual Helpline care. Currently the Helpline offers accurate and up to date verbal and written information on cancer prevention, early detection and treatment; links callers with services in their local area; and provides low-intensity emotional support. When patient distress is high or medical advice is required, referral to relevant services within or outside the CCNSW will be offered. Patients’ families or support persons will also be eligible to receive a call-out or make call-ins to the study Helpline number if desired. All calls will be logged using the existing client record management system.
Experimental group B: Proactive Online Delivered Support.
Usual Helpline content (as described above) will be provided via typed rather than spoken communication, using email and on-line chat. The first contact to participants allocated to this intervention arm will be via email from the CCNSW Helpline consultant. The email will explain the available electronic options for support (email delivered or on-line typed live chat). The same information will also be sent by hard-copy surface mail. Participants will be able to use either or both modes of electronic contact according to their preference. Following their first electronic session, participants will be offered an additional email contact from the CCNSW Helpline. As in Arm A, patients’ families or support person’s will be eligible to receive online support from the Helpline if desired. Most contact will be concluded within a 3 month period, however there is no tie limit on contact with the Helpline. All email and on-line contact will be logged within the existing client record management system.
Intervention code [1] 292638 0
Behaviour
Comparator / control treatment
Minimal Ethical Care (control): Patients in this condition will be mailed a booklet (“Understanding Lung Cancer”) from the CCNSW Helpline. The booklet will contain the study-specific Helpline telephone number and email address
Control group
Placebo

Outcomes
Primary outcome [1] 295894 0
The General Health Questionnaire-12 (GHQ12) uses 12 items to assess an individual’s perception of their health in terms of their ability to: play a useful part; make decisions; overcome difficulties; enjoy normal activities; face problems; and to feel confident, worthwhile, and happy. The time-frame of the GHQ-12 covers “the last 4 weeks” and items are scored using a four point scale (“Better than usual”, “Same as usual”, “Less than usual”, “Much less than usual”). Half of the items are worded positively, and the other half negatively. Items can be scored using either a Binary scale (0-1, maximum score = 12) or Likert scale (0-3, maximum score = 36), with a higher score indicating higher psychological distress.
Timepoint [1] 295894 0
6 months post-recuitment
Primary outcome [2] 295895 0
The heiQ (trademark) is an Australian-developed tool for assessing the efficacy and impact of health education and self-management programs for people with chronic diseases. Its 42 items are closely aligned to the nature of the Helpline intervention and map to 8 eight domains: 1) health directed behaviour; 2) positive and active engagement in life; 3) emotional well-being; 4) self-monitoring and insight; 5) constructive attitudes and approaches; 6) skill and technique acquisition; 7) social integration and support; and 8) health service navigation. Respondents indicate the degree to which they agree or disagree with each item on a 4 point scale. Standardised subscale scores (from 1 to 4) are calculated, with higher scores indicating better functioning.
Timepoint [2] 295895 0
6 months post-recruitment
Secondary outcome [1] 316882 0
Unmet needs: Two subscales of the 34-item Supportive Care Needs Survey (SCNS-SF34) will be used. The scale assesses cancer-specific perceived needs across five, factor analytically derived domains. The two relevant domains for this study are: 1) health systems and information; and 2) patient care and support. Respondents indicate their level of need for help over the last month on a five point Likert scale. Standardised domain scores ranging from 0 to 100 can be calculated
Timepoint [1] 316882 0
6 months post-recruitment

Eligibility
Key inclusion criteria
A primary diagnosis of lung cancer (any type including mesothelioma), up to 4 months post-diagnosis, have an approximate life expectancy of at least six months, are able to read English and have current internet access via any type of device.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None other than the inverse of the inclusion criteria

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Cancer Care Coordinator/nurses/clinicians will identify potentially eligible patients on their daily clinic appointment lists. The participant is enrolled via one of 3 approaches:
1. When the patient checks in for their appointment, reception staff or a research assistant will ask the patient whether they have internet access, provide study information materials to eligible patients, and invite them to participate in the study.
2. When the patient checks in for their appointment, reception staff will ask whether they have internet access and if they would be interested in being contacted by the research team regarding the study. Interested patients will be asked to complete a consent form for permission of the clinic to forward the patient’s contact details to the research team. Once consent forms are forwarded to the research team, patients will be contacted to discuss participation. Up to two follow-up contacts will be made to non-respondents. Patients who would like to participate in the study will be asked to complete a consent form to participate in the trial.
3. The staff member will mail information and make follow-up telephone calls to patients as part of standard care procedures. As part of these standard contacts, study materials (Information Statement and Consent Form) will be included mail-out package, and the staff member may also discuss the study when making calls to patients.
Once consent is obtained and the baseline survey is returned to the research team, the patient is randomised by the research team using central randomisation by computer to one of the three study groups (telephone support, on-line support or booklet only).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of individuals using block randomisation. Blocks are generated on demand as a new randomisation is required.Randomisation was performed using a random number generator with a random seed and non-varying block sizes. Randomisation was implemented in an online program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculation is based on the post-hoc contrasts. The comparison of each intervention group with minimal ethical care is a superiority analysis, whereas the comparison of the two intervention arms of the study is a non-inferiority analysis. The study aims to recruit 200 subjects per arm and therefore complete data will be available for approximately 150 patients at 6 months if we allow for a 25% loss to follow-up. This sample size will provide the study with more than 80% power to detect a difference between each of the intervention groups and the control group of 0.3 SD at an alpha level of 0.01 assuming the correlation between baseline and follow-up scores is at least 0.7. Effect sizes of 0.3-0.5 on the heiQ have been achieved in self-management interventions with hospital patients. This sample size will also provide the study with 90% power to claim non-inferiority in the comparison between the two interventions if the true underlying difference between the groups is 0.25 SDs for either the heiQ or GHQ-12.

Structural equation modelling will be used to develop models which relate to each of the study hypotheses. It is hypothesised that at 6 months follow-up:
1) Those in each of the two experimental conditions (Proactive Telephone Delivered Support and Proactive Online Delivered Support) will have GHQ-12 scores that are 0.3 of a standard deviation higher than those for the control condition and heiQ scores that are 0.3 of a standard deviation higher than those for the control condition; and
2) Those in the Proactive Online Delivered Support condition will have heiQ scores within 0.25 of a standard deviation of those in the Proactive Telephone Delivered Support condition.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/10/2014
Actual
2/10/2014
Date of last participant enrolment
Anticipated
31/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 4227 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 4228 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [3] 4229 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment hospital [4] 4230 0
Concord Repatriation Hospital - Concord
Recruitment hospital [5] 4231 0
Epworth Richmond - Richmond
Recruitment hospital [6] 4232 0
Illawarra Private Cancer Care & Research Centre - Wollongong
Recruitment hospital [7] 4233 0
Liverpool Hospital - Liverpool
Recruitment hospital [8] 4234 0
Manning Rural Referral Hospital (Taree) - Taree
Recruitment hospital [9] 4235 0
Royal Hobart Hospital - Hobart
Recruitment hospital [10] 4236 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [11] 4237 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [12] 4238 0
Blacktown Hospital - Blacktown
Recruitment hospital [13] 4239 0
Westmead Hospital - Westmead
Recruitment hospital [14] 4240 0
Orange Health Service - Orange
Recruitment hospital [15] 4241 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment hospital [16] 4242 0
Rockhampton Base Hospital - Rockhampton
Recruitment hospital [17] 4243 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [18] 4244 0
Southwest Health Care - Warrnambool - Warrnambool
Recruitment hospital [19] 4245 0
Prince of Wales Hospital - Randwick
Recruitment hospital [20] 4246 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [21] 4247 0
Cairns Base Hospital - Cairns
Recruitment hospital [22] 4248 0
John Flynn - Gold Coast Private Hospital - Tugun
Recruitment hospital [23] 4249 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [24] 4250 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [25] 6718 0
Southern Highlands Private Hospital - Bowral
Recruitment hospital [26] 6719 0
Mildura Base Hospital - Mildura
Recruitment hospital [27] 6720 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [28] 6721 0
Wimmera Health Care Group - Horsham - Horsham
Recruitment hospital [29] 6722 0
Stawell Regional Health - Stawell
Recruitment hospital [30] 6723 0
East Grampians Health Service - Ararat - Ararat
Recruitment hospital [31] 6724 0
Border Medical Oncology - Albury
Recruitment hospital [32] 6725 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [33] 6726 0
St John of God Hospital, Bunbury - Bunbury
Recruitment hospital [34] 6727 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [35] 6728 0
St John of God Hospital, Murdoch - Murdoch
Recruitment hospital [36] 6729 0
St George Hospital - Kogarah
Recruitment hospital [37] 6730 0
The Sutherland Hospital - Caringbah
Recruitment hospital [38] 6731 0
Genesis Cancer Care - Wesley - Auchenflower
Recruitment hospital [39] 6732 0
Genesis Cancer Care - Chermside - Chermside
Recruitment hospital [40] 6733 0
Genesis Cancer Care - Southport - Southport
Recruitment hospital [41] 6734 0
Genesis Cancer Care - Tugun - Tugun
Recruitment hospital [42] 6735 0
Nambour General Hospital - Nambour
Recruitment hospital [43] 6736 0
Gold Coast University Hospital - Southport
Recruitment hospital [44] 6737 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [45] 6738 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [46] 6739 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [47] 6740 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [48] 6741 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [49] 6747 0
Genesis Cancer Care - Nambour - Nambour
Recruitment postcode(s) [1] 14364 0
2576 - Bowral
Recruitment postcode(s) [2] 14365 0
3500 - Mildura
Recruitment postcode(s) [3] 14366 0
3168 - Clayton
Recruitment postcode(s) [4] 14367 0
3400 - Horsham
Recruitment postcode(s) [5] 14368 0
3380 - Stawell
Recruitment postcode(s) [6] 14369 0
3377 - Ararat
Recruitment postcode(s) [7] 14370 0
3690 - Wodonga
Recruitment postcode(s) [8] 14371 0
3000 - Melbourne
Recruitment postcode(s) [9] 14372 0
6230 - Bunbury
Recruitment postcode(s) [10] 14373 0
6008 - Subiaco
Recruitment postcode(s) [11] 14374 0
6150 - Murdoch
Recruitment postcode(s) [12] 14375 0
2217 - Kogarah
Recruitment postcode(s) [13] 14376 0
2229 - Caringbah
Recruitment postcode(s) [14] 14377 0
4066 - Auchenflower
Recruitment postcode(s) [15] 14378 0
4032 - Chermside
Recruitment postcode(s) [16] 14379 0
4215 - Southport
Recruitment postcode(s) [17] 14380 0
4224 - Tugun
Recruitment postcode(s) [18] 14381 0
4560 - Nambour
Recruitment postcode(s) [19] 14382 0
4101 - South Brisbane
Recruitment postcode(s) [20] 14383 0
5112 - Elizabeth Vale
Recruitment postcode(s) [21] 14384 0
5000 - Adelaide
Recruitment postcode(s) [22] 14385 0
4029 - Herston
Recruitment postcode(s) [23] 14386 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 291883 0
Government body
Name [1] 291883 0
NHMRC
Country [1] 291883 0
Australia
Funding source category [2] 291884 0
Charities/Societies/Foundations
Name [2] 291884 0
Cancer Council NSW
Country [2] 291884 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan, 2287 NSW
Country
Australia
Secondary sponsor category [1] 290549 0
Charities/Societies/Foundations
Name [1] 290549 0
Hunter Medical Research Institute
Address [1] 290549 0
1 Kookaburra Circuit, Rankin Park , NSW, 2305
Country [1] 290549 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293391 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 293391 0
Ethics committee country [1] 293391 0
Australia
Date submitted for ethics approval [1] 293391 0
Approval date [1] 293391 0
03/06/2014
Ethics approval number [1] 293391 0
14/05/21/4.03

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

Contacts
Principal investigator
Name 59690 0
A/Prof Christine Paul
Address 59690 0
W4 HMRI Building
1 Kookaburra Circuit
New Lambton Heights , NSW, 2305
Country 59690 0
Australia
Phone 59690 0
+61 2 40420693
Fax 59690 0
Email 59690 0
chris.paul@newcastle.edu.au
Contact person for public queries
Name 59691 0
Martine Cox
Address 59691 0
W4 HMRI Building
1 Kookaburra Circuit
New Lambton Heights 2305, NSW
Country 59691 0
Australia
Phone 59691 0
+61 2 40420695
Fax 59691 0
Email 59691 0
martine.cox@newcastle.edu.au
Contact person for scientific queries
Name 59692 0
Christine Paul
Address 59692 0
W4 HMRI Building
1 Kookaburra Circuit
New Lambton Heights 2305, NSW
Country 59692 0
Australia
Phone 59692 0
+61 2 40420693
Fax 59692 0
Email 59692 0
chris.paul@newcastle.edu.au

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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