Morrison, V., Spencer, L.H., Totton, N. orcid.org/0000-0002-1900-2773 et al. (11 more authors) (2018) Trial of Optimal Personalised Care After Treatment - Gynaecological Cancer (TOPCAT-G): A randomized feasibility trial. International Journal of Gynecological Cancer, 28 (2). pp. 401-411. ISSN 1048-891X
Abstract
Objective This study aimed to evaluate the feasibility of completing a parallel-group randomized controlled trial to compare usual follow-up care for women who have completed treatment of gynecological cancer against a nurse-led telephone intervention, known as Optimal Personalised Care After Treatment - Gynaecological. Methods The unblinded trial aimed to recruit patients who had completed treatment of cervical, endometrial, epithelial ovarian, or vulval cancer within the previous 3 months at 3 North Wales hospitals. We randomized participants to either usual hospital-based follow-up or specialist nurse-led telephone education, empowerment, and structured needs assessment follow-up. The primary outcomes assessed the feasibility of running a larger trial including patient eligibility, recruitment and retention rates, and outcome measure completion. Secondary outcomes were generic and health-related quality of life and a patient self-report health service use (Client Service Receipt Inventory) data collected at 3 time points (baseline, 3 months, and 6 months). Results Of the 58 women screened, 44 were eligible (76%) and 24 (55%) were recruited and randomized (12:12 to control and intervention, respectively). One participant was lost to follow-up. Recruited participants had a mean (SD) age of 60 (11.2) years and were approximately 5 months from their initial diagnosis (mean [SD], 159 [58] days). Seventeen (71%) of the participants had an endometrial cancer diagnosis. All outcome measure completion rates exceeded 96%. Although not a core feasibility objective, analyses of outcome measures indicated positive changes in quality of life and well-being within the Optimal Personalised Care After Treatment - Gynaecological group; exploratory cost consequence analysis indicated that the nurse-led intervention had a mean total service use cost of £27 per patient (bootstrapped 95% confidence interval, -£290 to £240) lower than did the standard care group. Conclusion Eligibility, recruitment, and retention rates as well as outcome measure completion showed that the trial is feasible.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2017 by IGCS and ESGO. This is an author produced version of a paper subsequently published in International Journal of Gynecological Cancer. Uploaded in accordance with the publisher's self-archiving policy. |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Health and Related Research (Sheffield) > ScHARR - Sheffield Centre for Health and Related Research |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 16 Apr 2018 14:19 |
Last Modified: | 01 Feb 2019 01:50 |
Published Version: | https://doi.org/10.1097/IGC.0000000000001179 |
Status: | Published |
Publisher: | Lippincott, Williams & Wilkins |
Refereed: | Yes |
Identification Number: | 10.1097/IGC.0000000000001179 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:128977 |