SCORE: A multisite randomised controlled trial evaluating shared care for colorectal cancer survivors.

Jefford, M; Emery, JD; Martin, AJ; De Abreu Lourenco, R; Lisy, K; Mohamed, MA; King, D; Tebbutt, NC; Lee, M; Mehrnejad, A; Burgess, A; Marker, J; Eggins, R; Carrello, J; Schofield, P

SCORE: A multisite randomised controlled trial evaluating shared care for colorectal cancer survivors.

Jefford, M Emery, JD Martin, AJ De Abreu Lourenco, R

Lisy, K Mohamed, MA King, D Tebbutt, NC Lee, M Mehrnejad, A Burgess, A Marker, J Eggins, R Carrello, J

Schofield, P

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Publisher:: American Society of Clinical Oncology (ASCO)
Publication Type:: Journal Article
Citation:: Journal of Clinical Oncology, 2023, 41, (4_suppl), pp. 84-84
Issue Date:: 2023-02-01

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Field	Value	Language
dc.contributor.author	Jefford, M
dc.contributor.author	Emery, JD
dc.contributor.author	Martin, AJ
dc.contributor.author	De Abreu Lourenco, R https://orcid.org/0000-0002-5978-8774
dc.contributor.author	Lisy, K
dc.contributor.author	Mohamed, MA
dc.contributor.author	King, D
dc.contributor.author	Tebbutt, NC
dc.contributor.author	Lee, M
dc.contributor.author	Mehrnejad, A
dc.contributor.author	Burgess, A
dc.contributor.author	Marker, J
dc.contributor.author	Eggins, R
dc.contributor.author	Carrello, J https://orcid.org/0000-0001-6423-6555
dc.contributor.author	Schofield, P
dc.date.accessioned	2024-01-22T00:29:37Z
dc.date.available	2024-01-22T00:29:37Z
dc.date.issued	2023-02-01
dc.identifier.citation	Journal of Clinical Oncology, 2023, 41, (4_suppl), pp. 84-84
dc.identifier.issn	0732-183X
dc.identifier.issn	1527-7755
dc.identifier.uri	http://hdl.handle.net/10453/174822
dc.description.abstract	<jats:p> 84 </jats:p><jats:p> Background: Colorectal cancer (CRC) survivorship is rising. Few studies have considered shared follow up (FU) care (SC) between oncologists and primary care providers (PCPs). SCORE is the first large RCT of SC for CRC survivors. Aim: to compare SC with usual care (UC) for CRC survivors. Primary objective: assess the effect of SC vs UC on the EORTC QLQ-C30 Global Health Status/Quality of Life (GHQ-QoL) scale to 12 months (mo). Secondary objectives: assess the effect of SC vs UC on QoL; pt perceptions of care; costs; clinical care processes (CEA tests, recurrences); and feasibility (recruitment, completion rate). Methods: Pts had stage I-III CRC, completed all treatments within 3 mo, spoke English, had a PCP, and no prior cancer. After pt consent, PCP could opt out. Pts were randomised 1 to 1 to SC or UC. SC replaced 2 routine oncologist visits with PCP visits and included a survivorship care plan, concerns checklist and management guidelines for the PCP. PCPs were asked to request CEA tests at 3 and 9 mo visits. Pts completed measures at baseline (BL) and at 6 and 12 mo FU. An estimate of the difference (diff) between groups on GHQ-QoL to 12 mo was obtained from a mixed model for repeated measures (MMRM). The test of non-inferiority was performed by evaluating the lower limit of the two-sided 95% confidence interval (CI) for the estimated diff (SC–UC) against a pre-specified non-inferiority margin (NIM) of -10 points. All randomised pts with available data were included in the primary analysis. Per-protocol population (PPP) comprised all randomised pts with ≥ 1 post-BL questionnaire (6 +/or 12 mo) and, for SC, ≥ 1 of the PCP visits. Results: 150 pts were randomised to SC (N=74) or UC (N=76); 11 PCPs declined. Median age 63 years, 39% women, 24% had radiotherapy. Primary: colon (59%), rectum (32%), overlapping (9%). 138/150 (92%) had BL and ≥1 post-BL GHQ-QoL score. 65/74 (88%) of SC pts attended 3- and/or 9-mo PCP visit. The mean (SD) GHQ-QoL scores at baseline / 6 mo / 12 mo were: 69 (18.7) / 69 (21.2) / 72 (20.2) for SC versus 68 (20.0) / 73 (15.1) / 73 (17.2) for UC. The MMRM mean estimate of GHQ-QoL across the 6 mo and 12 mo FU was 69 for SC and 73 for UC, mean diff -4.0 (95% CI: -9.0 to 0.9). The lower limit of the 95% CI did not cross the NIM. For the PPP (N=130/150), mean diff was -5.0 (95% CI: -10.1 to 0.2). No clear evidence of between group diffs on other C30 scales (accounting for multiplicity). At 12 mo, most popular preferences for FU were: SC for 40/63 (63%) in the SC group, similar preferences for SC 22/62 (35%) and ‘Hospital-based care with the doctors that treated the cancer’ 22/62 (35%) in UC. CEA completion was 89% at 3 and 83% at 9 mo in SC; 63% and 68% in UC. 5 recurrences in SC and 6 in UC arms. Conclusions: SCORE was highly feasible with high participation and retention, few PCPs declined. Compared to UC, pts having SC had non-inferior QoL. Adherence to CEA testing was higher in SC. Pts exposed to SC prefer this model of FU. Cost and implementation analyses will follow. Clinical trial information: ACTRN12617000004369 . </jats:p>
dc.language	en
dc.publisher	American Society of Clinical Oncology (ASCO)
dc.relation.ispartof	Journal of Clinical Oncology
dc.relation.isbasedon	10.1200/jco.2023.41.4_suppl.84
dc.rights	info:eu-repo/semantics/closedAccess
dc.subject	1103 Clinical Sciences, 1112 Oncology and Carcinogenesis
dc.subject.classification	Oncology & Carcinogenesis
dc.subject.classification	3211 Oncology and carcinogenesis
dc.title	SCORE: A multisite randomised controlled trial evaluating shared care for colorectal cancer survivors.
dc.type	Journal Article
utslib.citation.volume	41
utslib.for	1103 Clinical Sciences
utslib.for	1112 Oncology and Carcinogenesis
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Strength - CHERE - Centre for Health Economics Research and Evaluation
pubs.organisational-group	/University of Technology Sydney/Strength - CHT - Health Technologies
pubs.organisational-group	/University of Technology Sydney/Centre for Health Technologies (CHT)
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/Centre for Health Economics Research and Evaluation
utslib.copyright.status	closed_access	*
dc.date.updated	2024-01-22T00:29:36Z
pubs.issue	4_suppl
pubs.publication-status	Published
pubs.volume	41
utslib.citation.issue	4_suppl

Abstract:

84 Background: Colorectal cancer (CRC) survivorship is rising. Few studies have considered shared follow up (FU) care (SC) between oncologists and primary care providers (PCPs). SCORE is the first large RCT of SC for CRC survivors. Aim: to compare SC with usual care (UC) for CRC survivors. Primary objective: assess the effect of SC vs UC on the EORTC QLQ-C30 Global Health Status/Quality of Life (GHQ-QoL) scale to 12 months (mo). Secondary objectives: assess the effect of SC vs UC on QoL; pt perceptions of care; costs; clinical care processes (CEA tests, recurrences); and feasibility (recruitment, completion rate). Methods: Pts had stage I-III CRC, completed all treatments within 3 mo, spoke English, had a PCP, and no prior cancer. After pt consent, PCP could opt out. Pts were randomised 1 to 1 to SC or UC. SC replaced 2 routine oncologist visits with PCP visits and included a survivorship care plan, concerns checklist and management guidelines for the PCP. PCPs were asked to request CEA tests at 3 and 9 mo visits. Pts completed measures at baseline (BL) and at 6 and 12 mo FU. An estimate of the difference (diff) between groups on GHQ-QoL to 12 mo was obtained from a mixed model for repeated measures (MMRM). The test of non-inferiority was performed by evaluating the lower limit of the two-sided 95% confidence interval (CI) for the estimated diff (SC–UC) against a pre-specified non-inferiority margin (NIM) of -10 points. All randomised pts with available data were included in the primary analysis. Per-protocol population (PPP) comprised all randomised pts with ≥ 1 post-BL questionnaire (6 +/or 12 mo) and, for SC, ≥ 1 of the PCP visits. Results: 150 pts were randomised to SC (N=74) or UC (N=76); 11 PCPs declined. Median age 63 years, 39% women, 24% had radiotherapy. Primary: colon (59%), rectum (32%), overlapping (9%). 138/150 (92%) had BL and ≥1 post-BL GHQ-QoL score. 65/74 (88%) of SC pts attended 3- and/or 9-mo PCP visit. The mean (SD) GHQ-QoL scores at baseline / 6 mo / 12 mo were: 69 (18.7) / 69 (21.2) / 72 (20.2) for SC versus 68 (20.0) / 73 (15.1) / 73 (17.2) for UC. The MMRM mean estimate of GHQ-QoL across the 6 mo and 12 mo FU was 69 for SC and 73 for UC, mean diff -4.0 (95% CI: -9.0 to 0.9). The lower limit of the 95% CI did not cross the NIM. For the PPP (N=130/150), mean diff was -5.0 (95% CI: -10.1 to 0.2). No clear evidence of between group diffs on other C30 scales (accounting for multiplicity). At 12 mo, most popular preferences for FU were: SC for 40/63 (63%) in the SC group, similar preferences for SC 22/62 (35%) and ‘Hospital-based care with the doctors that treated the cancer’ 22/62 (35%) in UC. CEA completion was 89% at 3 and 83% at 9 mo in SC; 63% and 68% in UC. 5 recurrences in SC and 6 in UC arms. Conclusions: SCORE was highly feasible with high participation and retention, few PCPs declined. Compared to UC, pts having SC had non-inferior QoL. Adherence to CEA testing was higher in SC. Pts exposed to SC prefer this model of FU. Cost and implementation analyses will follow. Clinical trial information: ACTRN12617000004369 .

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