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Trial registered on ANZCTR


Registration number
ACTRN12613000731796
Ethics application status
Approved
Date submitted
28/06/2013
Date registered
2/07/2013
Date last updated
6/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A proactive and structured telephone based intervention to reduce carer burden and depression among carers of cancer patients
Scientific title
A Multi-centre randomized controlled trial to test the efficacy of a proactive and structured telephone based intervention to reduce carer burden and depression among carers of cancer patients
Secondary ID [1] 282756 0
Nil
Universal Trial Number (UTN)
U1111-1144-1713
Trial acronym
PROTECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carer burden 289492 0
Depression/anxiety 289493 0
Quality of life 289494 0
Unmet needs 289495 0
Health literacy 289496 0
Condition category
Condition code
Cancer 289820 289820 0 0
Any cancer
Mental Health 289821 289821 0 0
Depression
Mental Health 289844 289844 0 0
Anxiety

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

a) A proactive and structured Outcall program of information and support, delivered by experienced Cancer Council Helpline nurses to carers, that links them to a range of community based supportive care services as required;

b) Screening carers for distress and refers those with elevated levels to their GP for follow up psychological services to reduce their burden and improve their psychological health.

Participants randomised into the Intervention group will be contacted by a Cancer Council Helpline nurse as follows:
Using a standardized protocol and check list, a Cancer Council Helpline nurse will telephone participants 7-10 days post referral (Outcall One), four weeks later (Outcall Two), with the third outcall (Outcall Three) three months later.
For each outcall, seven Cancer Helpline outcall attempts over different times (eg 9am-1pm; 1pm-5pm; 5pm-6pm) across different week days over 2 weeks will be undertaken. After seven failed attempts and no response, a person will be declared ‘absent’ for a particular outcall. No further contact will be made until the next outcall is scheduled. All successful and failed attempts will be documented. Duration of each telephone call will be on average 20 minutes.
During each of the three outcalls, the Helpline nurse will administer the Distress Thermometer (DT) and will then raise six items for further discussion during which tailored information, support and specific carer resources will be provided. The areas selected for discussion have been specifically chosen to achieve the intended outcomes of reduced carer burden, improved psychological health and quality of life and increased health literacy and ability to navigate the health system. The six areas that will be addressed are:
1) Psychological distress
2) Health literacy
3) Health
4) Family support
5) Financial support
6) Practical advice
Intervention code [1] 287422 0
Prevention
Comparator / control treatment
Participants allocated to the control group (attention control, usual care) will receive three telephone outcalls by members of the research team at the same time points as the intervention group receives the Outcall program. The purpose of the call will be to remind participants in this group about the availability of the Cancer Helpline. Participants who choose to contact the Cancer Helpline will not receive the Outcall program but the usual support provided by cancer helpline nurses.
Control group
Active

Outcomes
Primary outcome [1] 289888 0
Primary Outcome (carer cohort): Carer burden as assessed by the Zarit Burden Interview (ZBI) and the Caregiver Reaction Assessment (subscale: self-esteem)
Timepoint [1] 289888 0
Timepoint: at baseline and at 1 and 6 month(s) post intervention
Secondary outcome [1] 303484 0
Secondary Outcome 1 (carer and patient cohort): Depression as assessed by the Centre for Epidemiological Studies Depression Inventory (CES-D)
Timepoint [1] 303484 0
Timepoint (carer cohort): at baseline and at 1 and 6 month(s) post intervention
Timepoint (patient cohort): at baseline and a 1 month post intervention
Secondary outcome [2] 303485 0
Secondary Outcome 2 (carer and patient cohort): Health education impact as assessed by The Health Education Impact Questionnaire (heiQ)
Timepoint [2] 303485 0
Timepoint (carer cohort): at baseline and at 1 and 6 month(s) post intervention
Timepoint (patient cohort): at baseline and a 1 month post intervention
Secondary outcome [3] 303486 0
Secondary Outcome 3 (carer and patient cohort): Health literacy as assessed by the Health Literacy Questionnaire (HLQ)
Timepoint [3] 303486 0
Timepoint (carer cohort): at baseline and at 1 and 6 month(s) post intervention
Timepoint (patient cohort): at baseline and a 1 month post intervention
Secondary outcome [4] 303487 0
Secondary Outcome 4 (carer and patient cohort): Supportive Care Needs as assessed by the Supportive Care Needs Survey for Partners & Carers (SCNS-P&C) and the Supportive Care Needs Survey for Patients (SCNS-P)
Timepoint [4] 303487 0
Timepoint (carer cohort): at baseline and at 1 and 6 month(s) post intervention
Timepoint (patient cohort): at baseline and a 1 month post intervention
Secondary outcome [5] 303488 0
Secondary Outcome 5 (carer cohort): Quality of Life as assessed by the Assessment of Quality of Life (AQoL-8D)
Timepoint [5] 303488 0
Timepoint (carer cohort): at baseline and at 1 and 6 month(s) post intervention
Secondary outcome [6] 303489 0
Secondary Outcome 6 (carer cohort): Resource Use as assessed by the Resource Use Questionnaire (RUQ)
Timepoint [6] 303489 0
Timepoint (carer cohort): at baseline and at 1 and 6 month(s) post intervention
Secondary outcome [7] 303490 0
Secondary Outcome 7 (carer cohort): Satisfaction with intervention (intervention group) and usual care (attention control group) as assessed using a Satisfaction Survey
Timepoint [7] 303490 0
Timepoint (carer cohort): at 1 month post intervention

Eligibility
Key inclusion criteria
Adults, aged 18 years or more, who are carer / newly diagnosed cancer patient dyads, where the patient is attending cycle 2-5 of adjuvant chemotherapy or fraction 2-10 for radiotherapy treatment for cancer, who are able to complete English language questionnaires; cancer patients will be diagnosed with curative intent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive dysfunction of either the cancer patient or the carer in the dyad. 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)
Method of allocation concealment used in this study: Central randomisation by computer
Staff members who will be identyfing and approaching eligible participants, will be unaware to which group (intervention or control) the participant will be allocated. In more detail: Carer / patient dyads will be approached by an experienced clinical trials or clinical research centre nurse in the out-patient setting. Each dyad will be given a brief introduction to the study and initial consent will be sought from both individuals for a researcher to contact them. Interested carers /patients will be given a study pack (plain language statement, consent form and baseline questionnaire). Within about 48 hours carers / patients will be contacted by the project coordinator by phone and consent sought. Consenting carer / patient dyads will be asked to complete the consent form and baseline questionnaires and post them to Deakin University. Consenting carer/patient dyads will be randomised into either the intervention group or the control group (usual care with reference to Cancer Helpline) via a computer-generated randomisation scheme produced by the trial statistician. For carers randomised into the intervention group, their names and phone numbers will be sent to the cancer nurse at the Cancer Council Helpline for subsequent follow up. To ensure the integrity of the trial’s procedures, all study staff and clinical trial / research centre nurses will undergo specific training and quality assurance assessments throughout the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participating carers / patient dyads will be allocated to treatment group via a computer-generated randomization scheme produced by the trial statistician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on our extensive previous research, the estimates of recruitment rate over the total recruitment indicate we will easily recruit our target sample. We have shown that approximately 70% of cancer patients indicated they had a carer during the treatment phase. Based on the number of new cases (~600/year; Health Services’ Information Services; 2011), if we assume conservatively that 1/3 of 600 new cases arrive for treatment with a carer at Cycle 2-5 / Fraction 2-10 across the 4 health services, a minimum of 16 carer /patient dyads will be recruited per month. Based on previous experience, we expect an 80% uptake so an overall recruitment phase of approximately 18 months to account for the greater challenge of recruiting the carer/patient dyad. For an 18 month recruitment period with 4 recruiting health services, we need to recruit an average of 4 dyads per month to yield approximately 288 dyads. With an anticipated attrition rate of 20%, this leaves us with around 180 completed dyads, which is sufficient for the planned statistical power of the trial.

An intention-to-treat (ITT) analysis will be performed. Analysis of covariance will be used to assess differences in 1 and 6 month outcomes between groups after adjusting for baseline differences. ITT analyses will be based on all [randomized and consented] participants. A ‘dose-response’ effect will be explored.
Repeated measures analysis using linear mixed models will assess the constancy of any effects of the Outcall program over time.
Qualitative analysis techniques will be used for data obtained from the telephone interviews. Thematic analysis from the interviews will be used and results will be discussed according to themes identified from the data.
A thematic analysis of the interviews with Cancer Council Victoria and Cancer Council South Australia and health service cancer nurses will determine experience of referral process, impact on workload, services utilised and any suggested improvements to the referral process and provision of services for carers.
Economic Analysis, this 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-8D will also enable a cost-utility analysis to be undertaken, thereby allowing practical judgements to be made regarding the value for money credentials of the intervention. The economic analysis will be primarily from the perspective of the health care sector though 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. Resource use will be accessed via the resource use questionnaire. Standardised economic evaluation techniques will be used including incremental analysis of mean differences and bootstrapping to determine confidence intervals.

Recruitment
Recruitment status
Completed
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)
SA,VIC
Recruitment hospital [1] 1179 0
Epworth Richmond - Richmond
Recruitment hospital [2] 1180 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 1181 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [4] 1182 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 7025 0
3121 - Richmond
Recruitment postcode(s) [2] 7026 0
3128 - Box Hill
Recruitment postcode(s) [3] 7027 0
3220 - Geelong
Recruitment postcode(s) [4] 7028 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 287525 0
Government body
Name [1] 287525 0
National Health and Medical Research Council (NHMRC)
Address [1] 287525 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 287525 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway
Burwood VIC 3125

Country
Australia
Secondary sponsor category [1] 286270 0
Individual
Name [1] 286270 0
Prof Richard Osborne
Address [1] 286270 0
Deakin University
Public Health Innovation
221 Burwood Highway
Burwood VIC 3125
Country [1] 286270 0
Australia
Secondary sponsor category [2] 286271 0
Individual
Name [2] 286271 0
Prof Mari Botti
Address [2] 286271 0
Deakin University
School of Nursing and Midwifery
221 Burwood Highway
Burwood VIC 3125
Country [2] 286271 0
Australia
Secondary sponsor category [3] 286272 0
Individual
Name [3] 286272 0
Prof David Ashley
Address [3] 286272 0
Barwon Health, The Andrew Love Cancer Centre
70 Swanston Street
Geelong VIC 3220
Country [3] 286272 0
Australia
Secondary sponsor category [4] 286273 0
Individual
Name [4] 286273 0
A/Prof Cathy Mihalopoulos
Address [4] 286273 0
Deakin University
Population Health SRC
221 Burwood Highway
Burwood VIC 3125
Country [4] 286273 0
Australia
Secondary sponsor category [5] 286274 0
Individual
Name [5] 286274 0
Dr Jacquie Chirgwin
Medical Oncologist
Address [5] 286274 0
Eastern Health
Nelson Road
Box Hill VIC 3128
Country [5] 286274 0
Australia
Secondary sponsor category [6] 286275 0
Individual
Name [6] 286275 0
Mr Sean McGuigan
Biostatistician
Address [6] 286275 0
Epworth HealthCare
89 Bridge Road
Richmond VIC 3121
Country [6] 286275 0
Australia
Other collaborator category [1] 277490 0
Charities/Societies/Foundations
Name [1] 277490 0
Cancer Council SA

Address [1] 277490 0
PO Box 929
Unley BC
Adelaide SA 5061
Country [1] 277490 0
Australia
Other collaborator category [2] 277491 0
Charities/Societies/Foundations
Name [2] 277491 0
Cancer Council Victoria

Address [2] 277491 0
1 Rathdowne Street
Carlton VIC 3053
Country [2] 277491 0
Australia
Other collaborator category [3] 277492 0
Other
Name [3] 277492 0
Carers Victoria

Address [3] 277492 0
Level 1
37 Albert Street
Footscray VIC 3011
Country [3] 277492 0
Australia
Other collaborator category [4] 277493 0
Other
Name [4] 277493 0
North Eastern Metropolitan Integrated Cancer Service (NEMICS)

Address [4] 277493 0
PO Box 5555
Heidelberg VIC 3084
Country [4] 277493 0
Australia
Other collaborator category [5] 277494 0
Other
Name [5] 277494 0
Barwon South Western Integrated Cancer Service (BSWICS)

Address [5] 277494 0
70 Swanston Street
Geelong VIC 3220
Country [5] 277494 0
Australia
Other collaborator category [6] 277495 0
Hospital
Name [6] 277495 0
Epworth HealthCare
Address [6] 277495 0
89 Bridge Road
Richmond VIC 3121
Country [6] 277495 0
Australia
Other collaborator category [7] 277496 0
Hospital
Name [7] 277496 0
Eastern Health – Box Hill Hospital

Address [7] 277496 0
Nelson Road
Box Hill VIC 3128
Country [7] 277496 0
Australia
Other collaborator category [8] 277497 0
Hospital
Name [8] 277497 0
Barwon Health – Geelong Hospital

Address [8] 277497 0
70 Swanston Street
Geelong VIC 3220
Country [8] 277497 0
Australia
Other collaborator category [9] 277498 0
Hospital
Name [9] 277498 0
Royal Adelaide Hospital

Address [9] 277498 0
North Terrace
Adelaide SA 5000
Country [9] 277498 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289502 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 289502 0
221 Burwood Highway, Burwood, VIC, 3125
Ethics committee country [1] 289502 0
Australia
Date submitted for ethics approval [1] 289502 0
Approval date [1] 289502 0
17/05/2013
Ethics approval number [1] 289502 0
2012_83
Ethics committee name [2] 289503 0
Eastern Health Research and Ethics Committee
Ethics committee address [2] 289503 0
5 Arnold Street, Box Hill, VIC, 3128
Ethics committee country [2] 289503 0
Australia
Date submitted for ethics approval [2] 289503 0
Approval date [2] 289503 0
08/05/2013
Ethics approval number [2] 289503 0
E29/1112
Ethics committee name [3] 289504 0
Epworth Healthcare Board of Management
Ethics committee address [3] 289504 0
89 Bridge Road, Richmond, VIC, 3121
Ethics committee country [3] 289504 0
Australia
Date submitted for ethics approval [3] 289504 0
Approval date [3] 289504 0
01/05/2013
Ethics approval number [3] 289504 0
587-13
Ethics committee name [4] 289505 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [4] 289505 0
North Terrace, Level 3, Hanson Institute, Adelaide, SA, 5000
Ethics committee country [4] 289505 0
Australia
Date submitted for ethics approval [4] 289505 0
Approval date [4] 289505 0
04/04/2013
Ethics approval number [4] 289505 0
HREC/13/RAH/69
Ethics committee name [5] 289506 0
Cancer Council Victoria Human Research Ethics Committee
Ethics committee address [5] 289506 0
1 Rathdowne Street, Carlton, VIC, 3121
Ethics committee country [5] 289506 0
Australia
Date submitted for ethics approval [5] 289506 0
Approval date [5] 289506 0
25/06/2013
Ethics approval number [5] 289506 0
HREC_1121

Summary
Brief summary
This study is evaluating a proactive and structured telephone based intervention for carers of cancer patients.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and a carer of a newly diagnosed cancer patient attending chemotherapy or radiotherapy treatment with curative intent.

Trial details
Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive the new telephone based intervention. This is a proactive and structured outcall program of information and support, delivered by experienced Cancer Council Helpline nurses to carers. The Helpline nurse screens carers for distress and links them to a range of community based supportive care services as required. Carers in this group will be contacted by a Cancer Council Helpline nurse at 7-10 days post referral (Outcall One), four weeks later (Outcall Two), and three months later (Outcall Three).
Participants in the second group will receive three telephone outcalls at the same timepoints as group one. The purpose of the calls is to remind participants about the availability of the Cancer Helpline. Participants who choose to contact the Cancer Helpline will not receive the Outcall program but the usual support provided by cancer helpline nurses.

Carers will complete questionnaires at Baseline, 1 month and 6 months, and patients will be complete questionnaires at Baseline and 1 month, in order to evaluate carer burden, psychological health, carers’ ability to navigate health services, quality of life, unmet needs, and cost-effectiveness.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41110 0
A/Prof Trish Livingston
Address 41110 0
Deakin University
221 Burwood Highway, Burwood, VIC, 3125, Australia
Country 41110 0
Australia
Phone 41110 0
+61 3 9244 6609
Fax 41110 0
Email 41110 0
trish.livingston@deakin.edu.au
Contact person for public queries
Name 41111 0
A/Prof Trish Livingston
Address 41111 0
Deakin University
221 Burwood Highway, Burwood, VIC, 3125, Australia
Country 41111 0
Australia
Phone 41111 0
+61 3 9244 6609
Fax 41111 0
Email 41111 0
trish.livingston@deakin.edu.au
Contact person for scientific queries
Name 41112 0
A/Prof Trish Livingston
Address 41112 0
Deakin University
221 Burwood Highway, Burwood, VIC, 3125, Australia
Country 41112 0
Australia
Phone 41112 0
+61 3 9244 6609
Fax 41112 0
Email 41112 0
trish.livingston@deakin.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary