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Trial registered on ANZCTR


Registration number
ACTRN12617000352303
Ethics application status
Approved
Date submitted
9/02/2017
Date registered
8/03/2017
Date last updated
30/01/2020
Date data sharing statement initially provided
13/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Structured triage and referral to reduce callers’ distress levels when using the Cancer Councils’ 13 11 20 telephone services
Scientific title
A randomised trial to implement systematic distress screening and structured care for callers using Cancer Councils' telephone services
Secondary ID [1] 290848 0
APP1112983
Universal Trial Number (UTN)
Trial acronym
START (Structured Triage And Referral by Telephone)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distress 301527 0
Cancer 301528 0
Condition category
Condition code
Cancer 301245 301245 0 0
Any cancer
Mental Health 301246 301246 0 0
Anxiety
Mental Health 301247 301247 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This stepped-wedge trial will be conducted in two cancer-specific telephone counselling services and will assess the comparative effectiveness of: i) Treatment as Usual (Arm 1): single-stage distress screening and unstructured referral to Cancer Council internal services; compared with ii) Structured Care (Arm 2): multi-stage distress screening and a structured referral model with follow up monitoring. Both Treatment as Usual (Arm 1) and Structured Care (Arm 2) will be delivered by trained consultants during the course of an inbound telephone call to the New South Wales and Victorian Cancer Councils’ 13 11 20 Cancer Information and Support service.

According to the stepped wedge design, the Structured Care (Arm 2) intervention will be rolled out sequentially over 3 6-month time periods: 1) all consultants will deliver Usual Care (Arm 1) from 0-6 months, 2) half of the consultants will be randomised to deliver Structured Care (Arm 2) and half will continue to deliver Usual Care (Arm 1) from 7-13 months, and 3) all consultants will deliver Structured Care (Arm 2) from 14-20 months. Accounting for a 1-month wash in period between each time period, the trial will be 20 months.

Arm 1 (Treatment as Usual): Depending on the course of the conversation, callers may be offered any of the following existing services by Cancer Council consultants: i) Online peer-based support and information; ii) Face-to-face support groups where people affected by cancer support each other; iii) One-to-one telephone support from a person who has recovered from a similar experience; iv) Telephone support group meetings of 3-7 members and qualified facilitators twice a month; v) referral to social work, legal, financial or transport assistance; vi) cancer survivor programs; vii) information resources; or viii) referral to a counsellor/psychologist. Callers may be offered one or more of these services based on the consultant’s clinical judgement and the caller's level of distress which is measured by a single-item screening tool (the Distress Thermometer [DT]).

Arm 2 (Structured Care): Consultants who are randomised to Arm 2 will administer a two-stage screening process (the DT plus PHQ-4). Based on these results, the consultant will refer to the structured care model and offer the caller those services which align with their level of distress (i.e mild, moderate or severe). The structured care model was developed specifically for this study by the University of Newcastle research team, Cancer Council NSW, and Cancer Council Victoria. Development included: i) a review of existing distress screening and management guidelines including the NCCN guidelines; 2) iterative discussion with place card mapping and think aloud methodology; and 3) pilot-testing.
The structured care model can be supplemented with an additional follow-up call involving repeat screening and further support for those with elevated or unchanged distress scores (i.e. stepped care). Those callers with moderate to severe distress will be offered this additional outbound call; if accepted, the call will be scheduled at least two weeks following the initial inbound call and dependant on other events (such as start or completion of treatment).

Callers allocated to Arm 1 (Treatment as Usual) will not be denied any services. Rather, callers within Arm 1 will not be assessed for service suitability in the systematic and structured fashion which will be the case for Arm 2 (Structured Care).

Intervention fidelity: To assess consultants’ fidelity to administering the DT (Arm 1 and 2), the PHQ-4 (Arm 2 only), and the structured care model (Arm 2 only), the research team will review a random sample of audio recordings. Furthermore, using the Client Record Management Systems it will be possible to audit the proportion of calls in which DT or PHQ-4 scores were recorded; participants will also be asked to report which services were offered during their call at a 3- and 6-month follow up survey.
Intervention code [1] 296788 0
Early detection / Screening
Intervention code [2] 296789 0
Treatment: Other
Intervention code [3] 296790 0
Behaviour
Comparator / control treatment
Treatment as usual (control): Consultants randomised to this group will refer callers to services based on their clinical judgement and DT scores. Those callers who receive Treatment as usual will not be denied any services. Rather, these callers will not be assessed for service suitability in the systematic and structured fashion which will be the case for the Structured Care group (intervention).
Control group
Active

Outcomes
Primary outcome [1] 300664 0
Primary Outcome 1 (referral uptake). The proportion of participants who were provided with a referral (based on review of call recordings and CRM data) and report that an action has been taken to progress the referral.
Timepoint [1] 300664 0
3 and 6 months post-recruitment
Primary outcome [2] 300665 0
Primary Outcome 2 (distress). General psychological distress will be measured by the GHQ-28 (General Health Questionnaire-28) which is a widely used, self-report measure of general psychological distress. The measure takes approximately 5 minutes to complete and uses 28 items to assess perception of health in terms of ability to: play a useful part in life; make decisions; overcome difficulties; enjoy normal activities; face problems; and feel confident, worthwhile, and happy over “the last 4 weeks”. The GHQ-28 has excellent internal consistency, diagnostic accuracy (sensitivity: 0.93; specificity: 0.92), and test-retest reliability. The measure has been validated and used in the Australian community and with cancer patients.
Timepoint [2] 300665 0
3 and 6 months post recruitment.
Secondary outcome [1] 330541 0
Secondary outcome 1 (Efficacy and impact of health education). The heiQ (Registered 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 map to eight domains. The heiQ has demonstrated reliability and validity, including with oncology samples.
Timepoint [1] 330541 0
3 and 6 months post recruitment
Secondary outcome [2] 330542 0
Secondary outcome 2 (Service provider costs). The service provider costs due to the uptake of referrals and differences in the length and frequency of calls for both groups (Treatment as Usual and Structured Care ) will be tracked through the Cancer Council client record systems and standard hourly costs applied to provide a full assessment of the cost implications for each of the care models.
Timepoint [2] 330542 0
3 and 6 months post-recruitment

Eligibility
Key inclusion criteria
Eligible participants will be Cancer Council 13 11 20 Information and Support Service callers who: reside in New South Wales or Victoria; are 18 years or older; have been diagnosed with cancer or cares for someone with cancer (such as a significant other); have a Distress Thermometer score of 4 or more; and consent to telephone follow-up.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Callers who express suicidal ideation are managed according to internal response protocols and may be excluded from study participation.

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)
Following a stepped-wedge design, consultants will be randomised to deliver either Treatment as Usual or Structured Care with all consultants delivering Structured Care at study completion. Allocation of consultants will be concealed when randomised at the start of the second 6-months time point and completed via an allocation schedule held off-site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) at the 6 months time-point after study commencement.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
This trial is a stepped wedge design with all: a) consultants delivering Treatment as Usual for the first six months; b)half of consultants randomised to deliver Structured Care for the second 6 month data collection period; and, c) all remaining consultants delivering Structured Care for the last 6 month data collection period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to assess referral uptake rates. Differences between GHQ-28 scores for the intervention and comparison group will be tested using a generalised linear model. The outcome in the models will be the GHQ-28 scores at 3 and 6 months, and the model will include terms for the intervention group, the interaction between the intervention group and time, which will allow the effect of the intervention on the outcome to be different at 3 and 6 months. A comparative effectiveness analysis will be completed to assess the differences in service provider costs between the two groups.

The trial aims to recruit a total of 1512 participants; this represents approximately 63 callers per consultant for each 6-month time period in the stepped wedge design and accounts for a 70% consent rate with 10% attrition at each data collection period. This sample size will provide the study with approximately 80% power to detect a difference of 0.3 standard deviations in the mean score of the GHQ-28 between the two study groups at an alpha level of 0.05 and assuming an intra-cluster correlation of 0.04. Effect sizes of 0.3 standard deviations or greater have been achieved in psychosocial support interventions using the GHQ-28 as an outcome measure.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
17/04/2017
Actual
15/05/2017
Date of last participant enrolment
Anticipated
30/06/2019
Actual
12/09/2019
Date of last data collection
Anticipated
30/04/2020
Actual
Sample size
Target
1512
Accrual to date
Final
1345
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 295282 0
Government body
Name [1] 295282 0
NHMRC
Country [1] 295282 0
Australia
Funding source category [2] 295283 0
Other
Name [2] 295283 0
Cancer Council NSW
Country [2] 295283 0
Australia
Funding source category [3] 295284 0
Other
Name [3] 295284 0
Cancer Council Vic
Country [3] 295284 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 294105 0
Other Collaborative groups
Name [1] 294105 0
Hunter Medical Research Institute
Address [1] 294105 0
1/1 Kookaburra Circuit, New Lambton Heights NSW 2305
Country [1] 294105 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296614 0
University of Newcastle
Ethics committee address [1] 296614 0
Ethics committee country [1] 296614 0
Australia
Date submitted for ethics approval [1] 296614 0
27/05/2016
Approval date [1] 296614 0
18/07/2016
Ethics approval number [1] 296614 0
H-2016-0180
Ethics committee name [2] 296616 0
Cancer Council NSW
Ethics committee address [2] 296616 0
Ethics committee country [2] 296616 0
Australia
Date submitted for ethics approval [2] 296616 0
17/05/2016
Approval date [2] 296616 0
29/06/2016
Ethics approval number [2] 296616 0
304
Ethics committee name [3] 296617 0
Cancer Council Victoria
Ethics committee address [3] 296617 0
Ethics committee country [3] 296617 0
Australia
Date submitted for ethics approval [3] 296617 0
09/06/2016
Approval date [3] 296617 0
05/08/2016
Ethics approval number [3] 296617 0
1605

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

Contacts
Principal investigator
Name 71478 0
Prof Christine L Paul
Address 71478 0
W4 Hunter Medical Research Institute Building
1 Kookaburra Circuit
New Lambton Heights , NSW, 2305
Country 71478 0
Australia
Phone 71478 0
+61 2 40420693
Fax 71478 0
Email 71478 0
chris.paul@newcastle.edu.au
Contact person for public queries
Name 71479 0
Elizabeth Fradgley
Address 71479 0
W4 Hunter Medical Research Institute Building
1 Kookaburra Circuit
New Lambton Heights , NSW, 2305
Country 71479 0
Australia
Phone 71479 0
+61 2 40420642
Fax 71479 0
Email 71479 0
elizabeth.fradgley@newcastle.edu.au
Contact person for scientific queries
Name 71480 0
Christine L Paul
Address 71480 0
W4 Hunter Medical Research Institute Building,
1 Kookaburra Circuit,
New Lambton Heights , NSW, 2305
Country 71480 0
Australia
Phone 71480 0
+61 2 40420693
Fax 71480 0
Email 71480 0
chris.paul@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
ethical considerations and data management policy, please email scientific contact.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.