SCORE: Shared care of Colorectal cancer survivors: protocol for a randomised controlled trial

A current major barrier is coordination of care between specialists and PCPs. Timely and systematic communication between specialists and PCPs is urgently required to clarify the roles and responsibilities of all, including the person with cancer [60]. We previously showed that faxing standardised information to PCPs about a patient’s chemotherapy regimen improved confidence of PCPs in managing adverse effects of treatment and increased satisfaction with shared care [61]. PCPs will be provided with timely patient-specific information and clinical guidance.

The majority of Australian patients with cancer want to be involved with decision-making and wish to participate in strategies to remain well [62]. Involving patients with chronic diseases in their disease management results in better communication with physicians, improved self-reported health and reduced health distress, fewer hospitalisations, and reduced health costs [63, 64]. A systematic review of patient activation approaches has shown these strategies can alter the content of consultations and improve the identification of patients’ concerns [65]. Approaches that allow patients to list and share their concerns with their doctors, particularly if linked to practitioner interventions, showed particular promise. Patients will have a mechanism to identify and discuss concerns with their PCP.

Cancer survivors have individualised needs [28, 66]. Therefore, interventions need to be systematically tailored to each individual. Authors of a review of tailored versus standardised information interventions in the health promotion area found that tailored interventions were significantly more effective in promoting health behaviour outcomes [67]. SCORE will enable both patients (survivors) and PCPs to identify issues of concern to the individual person.

The objectives of the trial are to operationalise and optimise the shared care intervention; establish acceptability of the intervention, randomisation, outcome measures and study processes; obtain preliminary estimates of effects on patient-reported outcome measures and health care resource use; and to confirm the appropriateness of expansion to a definitive phase III trial.

We hypothesise that, relative to usual care, shared care will be an acceptable model of follow-up with the potential to address care needs more efficiently than standard care.

This is a randomised, parallel group trial in which patients with CRC undergoing primary treatment with curative intent will be allocated to receive either standard specialist-based follow-up care or shared follow-up care between their specialist and PCP. Clinical reviews will occur at 3, 6, 9 and 12 months. Patient self-reported measures will be done at baseline and at 6 and 12 months. The trial will be conducted in accordance with good clinical practice guidelines and the Declaration of Helsinki. The protocol is in line with the Standard Protocol Items: Recommendations for Interventional Trials guidelines [68] and the Consolidated Standards for Reporting of Trials guidelines [69] (Fig. 1, study flow diagram) (Additional file 1). The trial is registered with the Australian New Zealand Clinical Trials Registry (number 12617000004369p).

The study will be conducted at the Peter MacCallum Cancer Centre, Royal Melbourne Hospital, Western Health, St Vincent’s Hospital and Austin Health, Melbourne, Victoria, Australia. Each site treats a considerable number of people with CRC.

Participants will receive either standard specialist-based follow-up care (usual follow-up care) or shared follow-up care between specialist and PCP (shared care intervention) for a period of 12 months.

Patients in the control group will receive usual care in accordance with hospital practice. Usual follow-up care occurs at 3-monthly intervals during the first year following the end of treatment and includes patient history, physical examination, blood test for carcinoembryonic antigen, and computed tomographic scan at 12 months if recommended by the patient’s treating specialist [34, 35, 70].

Patients in the intervention group will receive shared care between specialist and PCP. The shared care intervention will replace two specialist appointments at 3 and 9 months with PCP appointments and add an additional PCP appointment 2 to 6 weeks following the end of treatment to re-establish contact and discuss follow-up care. At baseline, participants allocated to shared care will receive additional resources, including a tailored survivorship care plan, a ‘Living Well after Cancer’ booklet [71] and a DVD titled ‘Just Take It Day to Day’ [72]. A common issues and concerns checklist will also be administered prior to PCP clinic attendance to assist with identification of individual needs. The survivorship care plan will be prepared by the research team and approved by the treating specialist, and it will include diagnosis, treatment history, details about additional hospital services received and information about common issues experienced by CRC survivors, and information about staying well and available community services. The PCP will receive a copy of the survivorship care plan and management guidelines detailing common issues experienced by CRC survivors and how to manage these, as well as how best to contact the specialist treating team for advice or if recurrence is suspected. Both patients and PCPs will receive a reminder letter about upcoming follow-up appointments, with PCPs further reminded to provide information on patient progress and have pathology results copied to specialist.

The primary outcome will be overall QoL at 12 months using the European Organisation for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30) [73]. Secondary outcomes include individual aspects of QoL, unmet needs, continuity of care and satisfaction.

Individual aspects of QoL: The EORTC QLQ-C30 functional and symptom scales and the CRC module (EORTC QLQ-CR29) [74] collectively assess specific symptoms such as fatigue, anxiety and pain as well as function on several domains, including physical, role, emotional, cognitive, social, sexual, urinary and bowel.

Survivors’ unmet needs: The Short-Form Survivor Unmet Needs Survey [75] is the brief version of the Survivor Unmet Needs Survey 89-item scale. It provides a measure of cancer survivors’ unmet needs, using 30 items across 5 domains: emotional health (8 items), access and continuity of care (6 items), relationships (5 items), financial concerns (8 items) and information (3 items). Each item is scored from 0 (no unmet need) to 4 (very high unmet need) [75].

Continuity of care: The Picker Ambulatory Oncology survey comprises eight items that assess patient experience of oncology care [76]. Three items are scored ‘yes completely’, ‘yes somewhat’ or ‘no’ and five items are scored ‘never’, ‘sometimes’, ‘usually’ or ‘always’. Each of the items is fractioned to the number of positive and negative responses. A total score is derived from these positive and negative responses [76].

Satisfaction: The Patient Satisfaction Questionnaire short form, derived from the 50-item Patient Satisfaction Questionnaire, comprises 18 items assessing satisfaction [77]. Seven subscales are used: general satisfaction (items 3 and 17), technical quality (items 2, 4, 6 and 14), interpersonal manner (items 10 and 11), communication (items 1 and 13), financial aspects (items 5 and 7), time spent with doctor (items 12 and 15), and accessibility and convenience (items 8, 9, 16 and 18). Each item is scored on a 5-point Likert scale ranging from ‘strongly agree’ to ‘strongly disagree’. Agreement on some scales indicates satisfaction, whereas agreement on other scales reflects dissatisfaction. All items are scored such that high scores reflect satisfaction with medical care.

Fidelity: There are two components to the fidelity section. First, participants are asked to respond whether additional specialist/PCP appointments were scheduled during the follow-up period. Second, there are eight questions that pertain to what participants remember receiving (e.g., survivorship care plan, DVD) as part of the intervention. Questions pertaining to these variables have been sourced from our previous follow-up care survey [27].

Participant time line: The assessment and appointment schedule is detailed in Fig. 2.

A sample size of 100 patients (50 in each arm) will allow estimation of key parameters with adequate precision to determine the appropriateness of expansion to a definitive phase III trial. The 95% CI for a retention rate of 90% for a study of this size would range from 82% to 95%. A retention rate below 80% would constitute grounds for modifying aspects of the study prior to expansion to a definitive phase III trial. Furthermore, the 95% CIs for the mean difference between the two groups on patient-reported outcome measures would extend no further than ±0.5 SD (given a retention rate of 90%). This level of precision corresponds to what has been proposed as a minimal clinically important difference for health-related QoL measures [78]. Evidence of a substantial detriment associated with shared care as measured by a reduction of 0.6 (or worse) on a patient-reported outcome measure would be detected with 80% power (at the 2.5% one-sided level of significance). A statistically significant negative finding on the global QoL scale from the EORTC QLQ-C30 would constitute grounds for abandoning expansion to a definitive phase III trial.

A research team will be appointed at each site. The research team will identify and screen potentially eligible patients from outpatient clinic lists as well as chemotherapy, surgery and radiotherapy lists, with the assistance of clinicians. Eligibility will be confirmed with the treating clinician prior to approach to clarify details from medical records and to ensure the clinician is aware of the patient’s involvement with the study.

Once it has been established that a patient is potentially eligible for the trial, the research team will approach the patient and invite him or her to participate (Additional files 2 and 3). Eligible and consenting patients will complete baseline measures prior to randomisation. The patient’s preferred PCP will be contacted to confirm willingness to be involved in the trial, should the patient be randomised to the intervention arm. An opt-out approach will be used. If the PCP returns the form noting that they prefer not to participate in the study, no further contact will be made. If the PCP contacts the research team stating they would like to take part, or if the form is not returned within 1 week, consent to take part in the study will be implied.

Patients who decline to participate will be asked for their verbal consent to collect basic demographic and clinical information from their records to examine potential recruitment bias. Reasons for refusal will be recorded.

The outcome measures will be taken at the end of treatment (baseline) and at 6 and 12 months. Recurrence will be collected at 6 and 12 months with fidelity measures being collected at 12 months. Arrangements of appointments will be self-managed by the participant throughout the trial period. Adherence to follow-up appointments will be collected through Medicare data at the end of the patient’s participation in the trial.

Costs and outcomes between usual care and shared care will be compared on the basis of resources required for the delivery of care and the use of medical services by patients. The comparison of outcomes will be focussed on the difference in the proportion of patients with unmet needs allowing an indicative assessment of the cost per additional patient whose needs are met by shared care compared with usual care. Results for the EORTC QLQ-C30 will be converted to preference-based measures of QoL (the EORTC Quality of Life Utility Measure–Core 10 dimensions) [79] for use in estimating quality-adjusted life-years (QALYs). With these data, a potential difference in costs per QALY between usual care and shared care will be explored in a model-based analysis. Differences in cost data will be subject to non-parametric testing, with appropriate sensitivity analyses conducted of comparisons of costs and outcomes [80].

The study has received ethics approval from the human research ethics committee of Peter MacCallum Cancer Centre (HREC/16/PMCC/89). No significant risks to participants are anticipated. Because the study is unblinded without drug intervention, an independent data and safety monitoring committee is unnecessary; however, the trial management committee will review the recruitment rate, the retention rate, and the data completion rate on an ongoing basis. The trial management committee includes CRC medical and surgical oncologists, PCPs, a behavioural scientist, a statistician, a health economist and a consumer.

Any adverse or unexpected outcomes which occur as a result of the trial will be documented and copies provided to site investigators and the principal investigator within 24 h. The principal investigator will proceed to report any such adverse event to the human research ethics committee.