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

Abstract

BackgroundColorectal cancer (CRC) is the most common cancer affecting both men and women. Survivors of CRC often experience various physical and psychological effects arising from CRC and its treatment. These effects may last for many years and adversely affect QoL, and they may not be adequately addressed by standard specialist-based follow-up. Optimal management of these effects should harness the expertise of both primary care and specialist care. Shared models of care (involving both the patient’s primary care physician [PCP] and specialist) have the potential to better support survivors and enhance health system efficiency.Methods/designSCORE (Shared care of Colorectal cancer survivors) is a multisite randomised controlled trial designed to optimise and operationalise a shared care model for survivors of CRC, to evaluate the acceptability of the intervention and study processes, and to collect preliminary data regarding the effects of shared care compared with usual care on a range of patient-reported outcomes. The primary outcome is QoL measured using the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. Secondary outcomes are satisfaction with care, unmet needs, continuity of care and health resource use. The shared care model involves replacement of two routine specialist follow-up visits with PCP visits, as well as the provision of a tailored survivorship care plan and a survivorship booklet and DVD for CRC survivors. All consenting patients will be randomised 1:1 to either shared care or usual care and will complete questionnaires at three time points over a 12-month period (baseline and at 6 and 12 months). Health care resource use data will also be collected and used to evaluate costs.DiscussionThe evaluation and implementation of models of care that are responsive to the holistic needs of cancer survivors while reducing the burden on acute care settings is an international priority. Shared care between specialists and PCPs has the potential to enhance patient care and outcomes for CRC survivors while offering improvements in health care resource efficiency. If the findings of the present study show that the shared care intervention is acceptable and feasible for CRC survivors, the intervention may be readily expanded to other groups of cancer survivors.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12617000004369p. Registered on 3 January 2017; protocol version 4 approved 24 February 2017.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2245-4) contains supplementary material, which is available to authorized users.

Health care provider and patient preparedness for alternative colorectal cancer follow-up; a review

“…An ongoing Danish randomized controlled trial is investigating remote follow-up as well, focusing on symptom burden and quality of life [26]. Two other RCTs, in Australia and in the Netherlands, are examining GP-led follow-up [27,28]. Results of the above-mentioned studies are expected in the near future.…”

Sharing Cancer Survivorship Care between Oncology and Primary Care Providers: A Qualitative Study of Health Care Professionals’ Experiences

“…Consensus on how primary care will fit with current models has not been reached [12]. Shared survivorship care between hospital-based and primary care providers is one model that has been investigated [13][14][15]. The first randomised controlled trial (RCT) to investigate shared care was the ProCare trial of survivors of prostate cancer [13].…”

“…Published in 2016, outcomes of the ProCare trial were in favour of shared care, demonstrating that shared care is not inferior to usual hospital-based care across a range of patient-reported outcomes, that it is preferred by patients and that it provides cost savings [13]. A further RCT currently underway is investigating the feasibility and effectiveness of shared care for survivors of colorectal cancer [14]. In this trial, two hospital appointments are replaced with GP visits in the first 12 months of follow-up, and survivors are supported through the provision of a survivorship care plan (SCP; a document summarising diagnosis, treatment, follow-up schedule and strategies to remain well [5]) and other information resources [14].…”

Differences in baseline characteristics and 1-year psychological factors between participants and non-participants in the randomized, controlled trial regarding patient-led follow-up after rectal cancer (FURCA)

“…However, the marked drop in the risk of local recurrence and the growing number of RC survivors call for a broader purpose of cancer follow-up and survivorship care. There is a need to draw more attention to the management of late effects, and alternative approaches for patient-centered care are emerging [7][8][9].…”

“…In order to address this issue, a multicenter randomized trial has been launched, introducing patient-led follow-up of RC survivors (Follow-Up after Rectal CAncer -FURCA) [7][8][9]. The aim is to improve patient-reported QoL and symptom burden by enhancing identification and management of late effects and symptoms.…”