Structured triage and referral to reduce callers’ distress levels when using the Cancer Councils’ 13 11 20 telephone services

INTERVENTION: 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). CONDITION: Cancer Distress 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. PRIMARY OUTCOME: 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. 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. SECONDARY OUTCOME: 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. 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. 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.