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Trial registered on ANZCTR


Registration number
ACTRN12616001251415
Ethics application status
Approved
Date submitted
2/09/2016
Date registered
7/09/2016
Date last updated
15/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A smartphone application for people with cancer to help reduce distress and unmet needs.
Scientific title
M-Health: Efficacy and Cost-effectiveness of a smartphone App to reduce distress and unmet needs in people with cancer (ACE): a randomized controlled trial.
Secondary ID [1] 290081 0
NHMRC # 1094831
Universal Trial Number (UTN)
U1111-1183-6914
Trial acronym
ACE
Linked study record
not applicable

Health condition
Health condition(s) or problem(s) studied:
Distess 300161 0
Unmet needs 300162 0
Quality of life 300163 0
Health literacy 300164 0
Cancer 300198 0
Condition category
Condition code
Cancer 300046 300046 0 0
Any cancer
Mental Health 300047 300047 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The smartphone application comprises:

a) the free downloadable ACE application to a smartphone or similar tablet device, providing patients access to their appointments; cancer information, improved access to the Cancer Council 13 11 20 Information and Support Service that links them by telephone follow up to a range of community based supportive care services as required; and
b) identification of distress with subsequent follow up by the Cancer Council 13 11 20 Information and Support Service for referral to psychological services. Those with elevated levels will be signaled by IT services and referred onto the 13 11 20 service for follow up with a name and contact telephone number.

This intervention supports the physical, psychological, social, and information needs of people with cancer and aims to reduce unmet needs and distress of people with cancer while improving their ability to participate in their own health care.

For participants randomized into the intervention group, the ACE application will be downloaded onto their Smartphone or similar tablet device and they will be shown features of the app.
For example, the ‘Appointments’ feature will allow participants to view their scheduled upcoming appointments and enable participants to view details of each booking and facilitate requests to re-schedule existing bookings (which will trigger an automatic email to oncology reception at their health service with subsequent telephone follow up to confirm change in appointment).
Other features include cancer information including links to reputable cancer specific websites for the participant to access; hospital maps for navigating around the hospital, improved access to the Cancer Council 13 11 20 telephone support service and available peer and online support groups; information on allied health services available at their health service, prompt to complete the Distress Thermometer (DT) at four time points: baseline and monthly thereafter for 3 months with follow up by the Cancer Council 13 11 20 Service for those with levels 7 or higher, which will trigger an automatic email to the Cancer Council 13 11 20 Service to follow up with the patient within 4 hours. In order to monitor adherence, monthly notifications will be sent to each participant through the app to complete the distress thermometer on the due date. Participants will be able to use the ACE application for a duration of four months.
Intervention code [1] 295819 0
Treatment: Devices
Intervention code [2] 295851 0
Treatment: Other
Comparator / control treatment
Participants allocated to the control group (usual care) will not receive the ACE smartphone application. Usual care provided to patients by the hospitals, such as information and support, will be provided by the health service.
Control group
Active

Outcomes
Primary outcome [1] 299520 0
Patient level of distress as assessed by the Impact of Events Scale (IES-R).
Timepoint [1] 299520 0
At baseline and at 4 and 12 month(s) post baseline
Secondary outcome [1] 327426 0
Patient’s unmet needs as assessed by the Supportive Care Needs Survey (SCNS-SF34).
Timepoint [1] 327426 0
at baseline and at 4 and 12 month(s) post baseline
Secondary outcome [2] 327427 0
Health education impact as assessed by The Health Education Impact Questionnaire (heiQ)
Timepoint [2] 327427 0
at baseline and at 4 and 12 month(s) post baseline
Secondary outcome [3] 327428 0
Health literacy as assessed by the Health Literacy Questionnaire (HLQ).
Timepoint [3] 327428 0
at baseline and at 4 and 12 month(s) post baseline
Secondary outcome [4] 327429 0
Quality of Life as assessed by the Assessment of Quality of Life (AQoL-4D).
Timepoint [4] 327429 0
at baseline and at 4 and 12 month(s) post baseline
Secondary outcome [5] 327430 0
Resource Use as assessed by the Resource Use Questionnaire (RUQ).
Timepoint [5] 327430 0
at baseline and at 4 and 12 month(s) post baseline
Secondary outcome [6] 327431 0
Satisfaction with smartphone application (intervention group only) as assessed using a Satisfaction Survey specifically designed for this trial.
Timepoint [6] 327431 0
at 4 and 12 month(s) post baseline

Eligibility
Key inclusion criteria
Adults, aged 18+ years, who are newly diagnosed cancer patients - all cancer types comprising both solid tumors and haematological cancers - with curative intent (stages 1-3), attending day oncology centers for cycle 2-5 of adjuvant chemotherapy or fraction 2-5 for radiotherapy treatment for cancer; who are able to complete English language questionnaires; and have access to a Smartphone or similar tablet device (Android or iOS).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive dysfunction of the cancer patient. Experienced health service oncology nurses will determine cognitive dysfunction, defined as overt psychotic illness or dementia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Trained personnel involved in the identification of eligible patients and personnel involved in the recruitment of those at each participating health service will be unaware to which group the patient will be allocated to.
Group allocation will be done off-site (at Deakin University) by the trial co-ordinator who is the holder of the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table produced by the trial statistician will be employed, stratified by age.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size
The primary outcome is a reduction in subjective stress in relation to a cancer diagnosis as measured by the total score on the IES-R. A linear mixed model analysis will be conducted and the F-test (at the 5% significance level) will be used to test for a study-arm by time interaction. The conjectured interaction is that there will be little change in the average score in the control group across the three assessments from baseline to 12 months but that the average score will decrease at 4 months in the app group and this lower average score (i.e. reduced stress) will be maintained (if not further decreased) at 12 months. In a large sample of Balkan war survivors, Morina et al reported mean (SD) total scores of 52 (17.8) and 17 (18.7) for survivors with and without PTSD respectively. Assuming a standard deviation as high as 20, an intraclass correlation of 0.2 (or as high as 0.8) and a study with 100 patients evaluated three times in each study arm, the F-test has 80% power to detect a reduction of 9.65 (or 4.83) at 4 months that is maintained (if not increased) at 12 months. These conjectured reductions correspond to effect sizes of 0.48 and 0.24, for ICC’s of 0.2 and 0.8 respectively, and could be described as medium to small. The maximum SD reported for the three sub-scales of the IES-R was 8, and the analogous F-test, for the same conjectured pattern of change in a sub-scale, has 80% power to detect a reduction of 3.86 (if the ICC=0.2) or 1.93 (if the ICC=0.8) in sub-scale means. Allowing for 20% attrition, 250 patients will be randomised into the study.
A secondary outcome is a reduction in unmet needs as measured by each of the five domains of the SCNS-SF34. The analysis of these domain scores will use the same approach as for the IES-R. The conjectured interaction is that there will be little change in the average score in the control group across the three assessments from baseline to 12 months but that the average score will decrease at 4 months in the app group and this lower average score (i.e. reduced unmet needs) will be maintained (if not further decreased) at 12 months. Mean (SD) domain scores for patients not in remission can range from 24 to 45 (SD = 25 to 29) and from 21 to 32 (SD = 21 to 27) in patients in remission. Assuming a standard deviation as high as 30, an intraclass correlation of 0.2 (or as high as 0.8) and a study with 100 patients evaluated three times in each study arm, the F-test has 80% power to detect a reduction of 14.5 (or 7.25) at 4 months that is maintained (if not increased) at 12 months. Reductions in this range are comparable to the significant differences (7.7 to 15.0), reported by Boyes et al, between cancer patients in, and not in, remission, for 5 domains of the SCNS-SF34.

Based on the number of new health service cancer cases (~600/year; Health Services’ Information Services; 2013), if we assume conservatively that 1/3 of 600 new cases arrive for treatment at Cycle 2-5 / Fraction 2-5 across the 4 health services and 2/3 have Smartphones or similar tablet devices, a minimum of 18 patients will be recruited per month. We expect an 80% uptake, so an overall recruitment phase of approximately 18 months to recruit our sample: 18 months * 18 patients across 4 health services = ~324 uptake * 80% uptake = ~250.

Patient data
An intention-to-treat (ITT) analysis will be performed on all endpoints. The intervention and control groups will be examined for baseline comparability with respect to demographic and other factors. The total IES-R and its three subscales, as well as each of the five domains of the SCNS-SF34 will be analysed by fitting linear mixed models. After identification of the most appropriate autocorrelation model for the repeated measurements, the F-test for the time by study-arm interaction will be used to compare the changes over time in each arm of the study. Comparisons of the arms at each of the two post-baseline time points will also be conducted using t-tests that utilize the estimated variances from the mixed model analyses. There will be no adjustment to the significance levels of these tests, either for multiplicity of endpoints or multiplicity of comparisons. A sensitivity analysis will also be conducted on the per-protocol set (PPS), i.e. the set of patients remaining on the study after 13 months without a major protocol deviation. Supplementary ITT analyses, using generalised linear mixed models (GLMMs) will also be conducted on the dichotomized domain scores of the SCNS-SF34 and the IES-R dichotomized at the cut-off (33+) for moderate to severe stress. No interim analyses are planned. The final analysis will be conducted after all participants have been assessed at 12 months or deemed lost-to-follow-up.

Economic Analysis
This economic evaluation will comprise a cost-consequences analysis where incremental costs of the intervention will be compared with the full spectrum of outcomes included in the study. This means that a series of cost-effectiveness ratios will be determined rather than just one – such an approach has been shown to be useful for decision-makers. The inclusion of the AQoL-4D will also enable a cost-utility analysis to be undertaken, thereby allowing practical judgements regarding value for money credentials of the intervention to be made. The economic analysis will be primarily from the perspective of the health care sector and a secondary analysis from the broader societal perspective will also be undertaken. The evaluation will first measure and value any change to the use of health care resources over the period of the study between the two arms of the trial (intervention and control) and then compare any additional costs to the additional outcomes achieved. This will be an important addition to the study given that one of the main impacts of the app will be the reduction of missed appointments and increased treatment adherence. Costs associated with the maintenance and ongoing provision of the ACE app will also be assessed and included in the intervention arm of the study. Standardized economic evaluation techniques will be used including incremental analysis of mean differences and bootstrapping to determine confidence intervals.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6613 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 6614 0
Epworth Richmond - Richmond
Recruitment hospital [3] 6615 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 14220 0
3128 - Box Hill
Recruitment postcode(s) [2] 14221 0
3121 - Richmond
Recruitment postcode(s) [3] 14222 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 294450 0
Government body
Name [1] 294450 0
National Health and Medical Research Council (NHMRC)
Address [1] 294450 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 294450 0
Australia
Primary sponsor type
University
Name
Deakin University - Professor Trish Livingston
Address
221 Burwood Highway
Burwood VIC 3125

Country
Australia
Secondary sponsor category [1] 293305 0
Hospital
Name [1] 293305 0
Barwon Health - University Hospital Geelong
Address [1] 293305 0
70 Swanston Street
Geelong VIC 3220
Country [1] 293305 0
Australia
Secondary sponsor category [2] 293306 0
Hospital
Name [2] 293306 0
Epworth HealthCare Richmond
Address [2] 293306 0
89 Bridge Road
Richmond VIC 3121
Country [2] 293306 0
Australia
Secondary sponsor category [3] 293307 0
Hospital
Name [3] 293307 0
Box Hill Hospital - Eastern Health
Address [3] 293307 0
Nelson Road
Box Hill VIC 3128
Country [3] 293307 0
Australia
Secondary sponsor category [4] 293308 0
Government body
Name [4] 293308 0
North Eastern Metropolitan Integrated Cancer Service (NEMICS)
Address [4] 293308 0
PO Box 5555
Heidelberg VIC 3084
Country [4] 293308 0
Australia
Secondary sponsor category [5] 293309 0
Government body
Name [5] 293309 0
Barwon South Western Integrated Cancer Service (BSWICS)
Address [5] 293309 0
70 Swanston Street
Geelong VIC 3220
Country [5] 293309 0
Australia
Secondary sponsor category [6] 293310 0
Government body
Name [6] 293310 0
Western & Central Melbourne Integrated Cancer Service (WCMICS)
Address [6] 293310 0
766 Elizabeth St, Melbourne Vic 3000
Country [6] 293310 0
Australia
Secondary sponsor category [7] 293311 0
Government body
Name [7] 293311 0
Cancer Council Victoria
Address [7] 293311 0
1 Rathdowne Street
Carlton VIC 3053
Country [7] 293311 0
Australia
Secondary sponsor category [8] 293312 0
Commercial sector/Industry
Name [8] 293312 0
ACRESTA
Address [8] 293312 0
15-17 Young Street
Sydney NSW 2000
Country [8] 293312 0
Australia
Secondary sponsor category [9] 293313 0
Commercial sector/Industry
Name [9] 293313 0
OPTUS
Address [9] 293313 0
1 Hoddle Street
Collingwood VIC 3066
Country [9] 293313 0
Australia
Other collaborator category [1] 279187 0
Individual
Name [1] 279187 0
Prof Mari Botti
Address [1] 279187 0
Deakin University
School of Nursing and Midwifery
221 Burwood Highway
Burwood VIC 3125
Country [1] 279187 0
Australia
Other collaborator category [2] 279188 0
Individual
Name [2] 279188 0
Prof David Ashley
Address [2] 279188 0
Barwon Health, The Andrew Love Cancer Centre
70 Swanston Street
Geelong VIC 3220
Country [2] 279188 0
Australia
Other collaborator category [3] 279189 0
Individual
Name [3] 279189 0
A/Prof Cathy Mihalopoulos
Address [3] 279189 0
Deakin University
Population Health SRC
221 Burwood Highway
Burwood VIC 3125
Country [3] 279189 0
Australia
Other collaborator category [4] 279190 0
Individual
Name [4] 279190 0
Dr Jacquie Chirgwin
Address [4] 279190 0
Medical Oncologist
Eastern Health
Nelson Road
Box Hill VIC 3128
Country [4] 279190 0
Australia
Other collaborator category [5] 279191 0
Individual
Name [5] 279191 0
Prof Suzanne Chambers
Address [5] 279191 0
Gold Coast campus
Menzies Health Institute Queensland
Griffith Health Centre
Parklands Drive
SOUTHPORT QLD 4222
Country [5] 279191 0
Australia
Other collaborator category [6] 279192 0
Individual
Name [6] 279192 0
Prof Victoria White
Address [6] 279192 0
Cancer Council Victoria
1 Rathdowne Street
Carlton VIC 3053

Country [6] 279192 0
Australia
Other collaborator category [7] 279193 0
Individual
Name [7] 279193 0
Dr Anna Boltong
Address [7] 279193 0
Cancer Council Victoria
1 Rathdowne Street
Carlton VIC 3053
Country [7] 279193 0
Australia
Other collaborator category [8] 279194 0
Individual
Name [8] 279194 0
Ms Ann Woollett
Address [8] 279194 0
University of Melbourne
Grattan Street
Parkville VIC 3010
Country [8] 279194 0
Australia
Other collaborator category [9] 279195 0
Individual
Name [9] 279195 0
Prof Mei Krishnasamy
Address [9] 279195 0
University of Melbourne
Grattan Street
Parkville VIC 3010
Country [9] 279195 0
Australia
Other collaborator category [10] 279196 0
Individual
Name [10] 279196 0
A/Prof Liliana Orellana
Address [10] 279196 0
Deakin University
Faculty of Health – Biostatistics Unit
221 Burwood Highway
Burwood VIC 3125
Country [10] 279196 0
Australia
Other collaborator category [11] 279197 0
Individual
Name [11] 279197 0
Prof Nilmini Wickramasinghe
Address [11] 279197 0
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country [11] 279197 0
Australia
Other collaborator category [12] 279198 0
Individual
Name [12] 279198 0
Dr Anna Ugalde
Address [12] 279198 0
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country [12] 279198 0
Australia
Other collaborator category [13] 279199 0
Individual
Name [13] 279199 0
A/Prof John Reynolds
Address [13] 279199 0
Monash University – The Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country [13] 279199 0
Australia
Other collaborator category [14] 279200 0
Individual
Name [14] 279200 0
A/Prof Phillip Parente
Address [14] 279200 0
Eastern Health – Box Hill Hospital
Nelson Road
Box Hill VIC 3128
Country [14] 279200 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295882 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 295882 0
10 St Andrews Place, East Melbourne, VIC 3002
Ethics committee country [1] 295882 0
Australia
Date submitted for ethics approval [1] 295882 0
10/09/2015
Approval date [1] 295882 0
16/12/2015
Ethics approval number [1] 295882 0
HREC/15/PMCC/66
Ethics committee name [2] 295885 0
Epworth HealthCare Human Research Ethics Committee
Ethics committee address [2] 295885 0
89 Bridge Road
Richmond VIC 3121
Ethics committee country [2] 295885 0
Australia
Date submitted for ethics approval [2] 295885 0
10/09/2015
Approval date [2] 295885 0
15/12/2015
Ethics approval number [2] 295885 0
705-15
Ethics committee name [3] 295886 0
Deakin University Human Research Ethics Committee
Ethics committee address [3] 295886 0
221 Burwood Highway
3125 Burwood VIC
Ethics committee country [3] 295886 0
Australia
Date submitted for ethics approval [3] 295886 0
02/08/2016
Approval date [3] 295886 0
22/08/2016
Ethics approval number [3] 295886 0
2016-265

Summary
Brief summary
The primary purpose of this trial is to evaluate the efficacy and cost-effectiveness of the ACE smartphone application for reducing distress and unmet needs in cancer patients.

Who is it for?
You may be eligible to participate in this trial if you are aged 18 or over and have been newly diagnosed with any cancer type including both solid tumors and haematological cancer stages 1-3, attending day oncology centers for cycle 2-5 of adjuvant chemotherapy or fraction 2-5 for radiotherapy treatment for cancer. You must also speak English and have access to a Smartphone or similar tablet device (Android or iOS).

Study details
All participants enrolled in this study will be randomly allocated (by chance) to receive the ACE smartphone application or to receive standard care with no smartphone application. Those in the ACE group will receive access to the application for four months. The ACE application allows participants to view and amend their existing appointments, provides links to cancer information and improved access to the Cancer Council Information and Support Service helpline. The application will also ask participants to rate their level of distress once per month, and participants with elevated distress levels will be referred to the Cancer Council Helpline for a follow-up support phone call.

All participants will complete a number of questionnaires relating to their distress, quality of life and use of healthcare resources at enrollment and 4 and 12 months after enrolment.

It is hoped that this study will show that the ACE smartphone application is a cost-effective tool for reducing distress and unmet needs in cancer patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68802 0
Prof Trish Livingston
Address 68802 0
Deakin University
Facutly of Health
221 Burwood Highway
Burwood 3125 VIC
Country 68802 0
Australia
Phone 68802 0
+613 9244 6609
Fax 68802 0
Email 68802 0
trish.livingston@deakin.edu.au
Contact person for public queries
Name 68803 0
Prof Trish Livingston
Address 68803 0
Deakin University
Facutly of Health
221 Burwood Highway
Burwood 3125 VIC
Country 68803 0
Australia
Phone 68803 0
+613 9244 6609
Fax 68803 0
Email 68803 0
trish.livingston@deakin.edu.au
Contact person for scientific queries
Name 68804 0
Prof Trish Livingston
Address 68804 0
Deakin University
Facutly of Health
221 Burwood Highway
Burwood 3125 VIC
Country 68804 0
Australia
Phone 68804 0
+613 9244 6609
Fax 68804 0
Email 68804 0
trish.livingston@deakin.edu.au

No information has been provided regarding IPD availability
Summary results
No Results