Clinical effectiveness and cost-effectiveness of the Needs Assessment Tool-Cancer in primary care (CANAssess2): a pragmatic, cluster-randomised, controlled trial

Background The Needs Assessment Tool-Cancer (NAT-C) is a consultation guide to identify and triage patients' and carers' cancer-related unmet needs, but its effectiveness in primary care is unknown. We aimed to evaluate the clinical effectiveness and cost-effectiveness of the NAT-C in reducing patient unmet needs and reducing carer burden in primary care. Methods The Cancer Patients' Needs Assessment in Primary Care (CANAssess2) trial was a pragmatic, cluster-randomised, controlled trial of the NAT-C versus usual care in patients aged 18 years and older with active cancer (ie, receiving anticancer treatment with curative or palliative intent; managed with a watch and wait approach; or with recurrent or metastatic disease), conducted across northeast England and Yorkshire. Eligible general practices (clusters) were willing to be trained and deliver the NAT-C for recruited patients if so allocated, were willing to commit to trial procedures, and gave written informed practice-level consent. Practices were randomly assigned (1:1) to deliver the NAT-C intervention or usual care alone by use of minimisation incorporating a random element to ensure treatment groups were well balanced for patient list size, locality, and training centre status. Patients and carers (family or friend nominated by patient) consented to complete follow-up questionnaires at baseline, 1 month, 3 months, and 6 months and attend a NAT-C appointment if registered with an intervention practice. The primary outcome was at least one moderate-to-severe unmet need at 3 months (according to the Supportive Care Needs Survey-Short Form 34 [SCNS-SF34]). Secondary outcomes included at least one moderate-to-severe unmet need at 1 month and 6 months, level of unmet needs (SCNS-SF34 score), symptoms (Revised Edmonton Symptom Assessment System [ESAS-r]), mood and quality of life (EQ-5D-5L and European Organisation for Research and Treatment of Cancer Quality of Life-C15-Palliative questionnaire [EORTC QLQ-C15-PAL]), performance status (Australia-modified Karnofsky Performance Score), carers' ability to care, and carer wellbeing, at all timepoints. Primary effectiveness analyses were done in all participants with at least one post-baseline measurement (at either 1, 3, or 6 months) according to modified intention-to-treat principles. The original sample size target of 1080 participants across 54 practices was reduced in a protocol amendment to 950 across at least 38 practices due to recruitment challenges and improved retention. The trial is registered with ISRCTN, ISRCTN15497400. Findings Between Oct 21, 2020, and April 12, 2023, of 65 general practices screened, 41 (63%) were randomly assigned: 21 (51%) to NAT-C and 20 (49%) to usual care. Between Dec 1, 2020, and Aug 30, 2023, 788 participants (mean age 66·9 years, SD 10·9; 404 [51%] female and 384 [49%] male) were enrolled: 376 (48%) in the NAT-C group and 412 (52%) in the usual care group. 427 (54%) of 788 participants identified a potentially eligible carer, and a carer was recruited alongside 249 (32%) participants. Follow-up was completed on Jan 19, 2024. For the 3-month primary outcome, 149 (46%) of 321 participants in the NAT-C group and 173 (48%) of 364 participants in the usual care group reported at least one moderate-to-severe unmet need (odds ratio [OR] 0·98 [95% CI 0·63 to 1·53]; p=0·94; intracluster correlation coefficient 0·067). There was no evidence of benefit for any clinical effectiveness outcomes at 1 month or 3 months. However, at 6 months we found evidence that the NAT-C was superior to usual care at reducing the level of unmet need (mean difference –3·57, 95% CI –6·57 to –0·58; p=0·020; predominantly psychological and physical needs). There was also evidence of benefit in the NAT-C group on 6-month symptoms (ESAS-r mean difference –2·98, 95% CI –5·35 to –0·61; p=0·014) and mood and quality of life (mean difference in EORTC QLQ-C15-PAL domains of overall quality of life 3·97, 1·03 to 6·91, p=0·0082; pain –3·81, –7·26 to –0·35, p=0·031; appetite loss –4·02, –7·31 to –0·72, p=0·017; emotional functioning 3·54, 0·21 to 6·87, p=0·037). There was weak evidence of benefit for the 6-month outcome of at least one moderate-to-severe unmet need (OR 0·66, 95% CI 0·42 to 1·04; p=0·075), but no evidence of benefit on performance status (mean difference –0·02, –2·22 to 2·17; p=0·98), carers' ability to care (–0·06, –4·21 to 4·09; p=0·98), or wellbeing (0·00, –1·90 to 1·90; p=0·99). Interpretation We found no evidence of benefit of the NAT-C versus usual care at the 3-month primary endpoint timepoint. However, our data suggest potential benefits for patients at 6 months, although future studies with longer follow-up are needed to clarify these findings. Funding Yorkshire Cancer Research.

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