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Cooperative Group
Trial of Optimal Personalised Care After Treatment—Gynaecological Cancer (TOPCAT-G): A Randomized Feasibility Trial
  1. Val Morrison, PhD*,
  2. Llinos H. Spencer, PhD†,
  3. Nikki Totton, MSc†,
  4. Kirstie Pye, PhD†,
  5. Seow Tien Yeo, MSc‡,
  6. Caryl Butterworth, RN§,
  7. Liz Hall, RN§,
  8. Rhiannon Whitaker, MSc∥,
  9. Rhiannon Tudor Edwards, DPhil‡,
  10. Laura J. Timmis, BSc*,
  11. Zoe Hoare, PhD†,
  12. Richard D. Neal, PhD,
  13. Clare Wilkinson, PhD# and
  14. Simon Leeson, MB, ChB, BSc, FRCS, FRCOG§
  1. *School of Psychology,
  2. †North Wales Organisation for Randomised Trials in Health (NWORTH) Clinical Trial Unit, Bangor Institute for Health and Medical Research (BIHMR),
  3. ‡Centre for Health Economics and Medicines Evaluation (CHEME), School of Healthcare Sciences, Bangor University;
  4. §Department of Obstetrics and Gynaecology, Ysbyty Gwynedd Hospital, Betsi Cadwaladr University Health Board;
  5. ∥Whitaker Research Ltd, Bangor;
  6. Academic Unit of Primary Care, Leeds Institute of Health Sciences, University of Leeds, Leeds; and
  7. #North Wales Centre for Primary Care Research, Bangor Institute for Health and Medical Research (BIHMR), School of Healthcare Sciences, Bangor University, Bangor, United Kingdom.
  1. Address correspondence and reprint requests to Simon Leeson, MB, ChB, BSc, FRCS, FRCOG, Department of Obstetrics and Gynaecology, Ysbyty Gwynedd Hospital, Bangor, LL57 2PW, United Kingdom. E-mail: simon.leeson@wales.nhs.uk.

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.

  • Gynecological cancer
  • Follow-up
  • Nurse-led telephone intervention
  • Randomized controlled trial
  • Quality of life
  • Health economics
  • Feasibility study

https://doi.org/10.1097/IGC.0000000000001179

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    Footnotes

    • Funding and Sponsor: The Trial of Optimal Personalised Care After Treatment—Gynaecological Cancer study was funded and sponsored by the Betsi Cadwaladr University Health Board in Bangor, United Kingdom.

    • The authors declare no conflicts of interest.

    • Authors' Contributions: V.M. contributed to the study concept, study design, development of intervention, development of study protocol, health psychology oversight, and review of the manuscript; L.H.S., trial management (May 2016–January 2017), and preparation, drafting, and review of the manuscript; N.T., development of study protocol, data management, statistical analysis and interpretation of results, and drafting and review of the manuscript; K.P., study design, development of intervention, development and writing of study protocol, trial management (July 2014–October), and review of the manuscript; S.T.Y., study design, development of intervention, development of study protocol, design and development of health service use questionnaire, health economic analysis and interpretation of results, and drafting and review of the manuscript; C.B., development of study protocol, screening and recruitment of participants, data collection, and review of the manuscript; L.H., development of study protocol, screening and recruitment of participants, implementation of intervention, data collection, and review of the manuscript; R.h.W., study concept, study funding, study design, development of intervention, development of study protocol, patient representative, and review of the manuscript; R.T.E., study design, development of intervention, development of study protocol, health economic oversight, and review of the manuscript; L.J.T., development of study protocol, review of the manuscript, and being a Tenovus PhD student on a related study; Z.H., statistical oversight and review of the manuscript; R.D.N., study design, development of study protocol, and review of the manuscript; C.W., study design, development of study protocol, and review of the manuscript; S.L., study concept, study design, development of intervention, development of study protocol, study oversight, review of the manuscript, and being a chief investigator.

    • Supplemental digital content is available for this article. Direct URL citation appears in the printed text and is provided in the HTML and PDF versions of this article on the journal’s Web site (www.ijgc.net).