Todd, Adam, Clark, Joseph, Amoakwa, Elvis, Wright-Hughes, Alexandra, Blenkinsopp, John, Currow, David C., Meads, David, Farrin, Amanda, Allgar, Victoria, Macleod, Una and Johnson, Miriam (2021) A cluster randomised trial of a Needs Assessment Tool for adult Cancer patients and their carers (NAT-C) in primary care: A feasibility study. PLoS ONE, 16 (1). e0245647. ISSN 1932-6203
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Abstract
Background: People with cancer often have unidentified symptoms and social care needs. The Needs Assessment Tool-Cancer (NAT-C) is a validated, structured method of assessing patient/carer concerns and prompting action, to address unmet need. Aims: Assess feasibility and acceptability of a definitive two-armed cluster randomised trial of NAT-C in primary care by evaluating: recruitment of GP practices, patients and carers; most effective approach of ensuring NAT-C appointments, acceptability of study measures and follow-up. Methods: Non-blinded, feasibility study in four General Practices, with cluster randomisation to method of NAT-C appointment delivery, and process evaluation. Adults with active cancer were invited to participate with or without carer. Practices cluster randomised (1:1) to Arm I: promotion and use of NAT-C with a NAT-C trained clinician or Arm II: clinician of choice irrespective of training status. Participants completed study questionnaires at: baseline, 1, 3 and 6 months. Patients booked a 20 minute needs-assessment appointment post-baseline. Patients, carers and GP practice staff views regarding the study sought through interviews/focus groups. Quantitative data were analysed descriptively. Qualitative data were analysed thematically, informed by Normalisation Process Theory. Progression to a definitive trial was assessed against feasibility outcomes, relating to: recruitment rate, uptake and delivery of the NAT-C, data collection and quality. Results: Five GP practices approached, four recruited and trained to use the NAT-C. Forty-seven participants and 17 carers recruited. At baseline, 34/47 (72%) participants reported at least one moderate-severe unmet need, confirming study rationale. 32/47 (68%) participants received a NAT-C-guided consultation, 19 of which on Arm I. Study attrition at one month (n = 44 (94%), n = 16 (94%)), three months (n = 38 (81%), n = 14 (82%)) and six months (n = 32 (68%), n = 10 (59%)). Fifteen patient interviews conducted across the whole study and one focus group at each GP practice. Participants supported a definitive study and found measures acceptable. Conclusion: The feasibility trial indicated that recruitment rate, intervention uptake and data collection were appropriate, with refinements, for a definitive multi-centre cluster randomised controlled trial. Feasibility outcomes informed the design of a 2-armed cluster randomised controlled trial to test the effectiveness and cost-effectiveness of the NAT-C compared with usual care.
| Item Type: | Article |
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| Additional Information: | This study was funded by Yorkshire Cancer Research (Registered Charity 516898), grant award number H397. MJ was the Principal Applicant. The Co-Applicants were UM, AJF, DM, AWH, JB, DC, RF, SW, VLA, HSFF. No commercial companies funded either the study or any of the authors. The study was sponsored by the University of Hull (www.hull.ac.uk). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. |
| Subjects: | B100 Anatomy, Physiology and Pathology B900 Others in Subjects allied to Medicine |
| Department: | Faculties > Business and Law > Newcastle Business School |
| Depositing User: | Elena Carlaw |
| Date Deposited: | 29 Jan 2021 09:38 |
| Last Modified: | 31 Jul 2021 14:37 |
| URI: | http://nrl.northumbria.ac.uk/id/eprint/45331 |
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