Getting the MOST out of follow-up: a randomized controlled trial comparing 3 monthly nurse led follow-up via telehealth, including monitoring CA125 and patient reported outcomes using the MOST (Measure of Ovarian Symptoms and Treatment concerns) with routine clinic based or telehealth follow-up, after completion of first line chemotherapy in patients with epithelial ovarian cancer

Paul A Cohen; Penelope M Webb; Madeleine King; Andreas Obermair; Val Gebski; Phyllis Butow; Rachael Morton; Wanda Lawson; Patsy Yates; Rachel Campbell; Tarek Meniawy; Michelle McMullen; Andrew Dean; Jeffrey Goh; Orla McNally; Linda Mileshkin; Philip Beale; Rhonda Beach; Jane Hill; Cyril Dixon; Sue Hegarty; Jim Codde; Angela Ives; Yeh Chen Lee; Alison Brand; Anne Mellon; Sanela Bilic; Isobel Black; Stephanie Jeffares; Michael Friedlander

doi:10.1136/ijgc-2021-002999

Getting the MOST out of follow-up: a randomized controlled trial comparing 3 monthly nurse led follow-up via telehealth, including monitoring CA125 and patient reported outcomes using the MOST (Measure of Ovarian Symptoms and Treatment concerns) with routine clinic based or telehealth follow-up, after completion of first line chemotherapy in patients with epithelial ovarian cancer

Int J Gynecol Cancer. 2022 Apr 4;32(4):560-565. doi: 10.1136/ijgc-2021-002999.

Authors

Paul A Cohen^{1

2

3}, Penelope M Webb⁴, Madeleine King⁵, Andreas Obermair⁶, Val Gebski⁷, Phyllis Butow^{8

9}, Rachael Morton⁷, Wanda Lawson¹⁰, Patsy Yates¹¹, Rachel Campbell⁵, Tarek Meniawy¹², Michelle McMullen¹², Andrew Dean¹³, Jeffrey Goh^{14

15}, Orla McNally^{16

17}, Linda Mileshkin^{18

19}, Philip Beale²⁰, Rhonda Beach¹⁰, Jane Hill²¹, Cyril Dixon²¹, Sue Hegarty²¹, Jim Codde³, Angela Ives²², Yeh Chen Lee^{23

24}, Alison Brand^{25

26}, Anne Mellon²⁷, Sanela Bilic²⁸, Isobel Black²⁸, Stephanie Jeffares²⁸, Michael Friedlander^{23

29}

Affiliations

¹ Department of Gynaecological Oncology, St John of God Subiaco Hospital, Subiaco, Western Australia, Australia paul.cohen@uwa.edu.au.
² Division of Obstetrics and Gynaecology, Faculty of Health and Medical Sciences, University of Western Australia, Perth, Western Australia, Australia.
³ Institute for Health Research, The University of Notre Dame Australia, Fremantle, Western Australia, Australia.
⁴ Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia.
⁵ Faculty of Science, School of Psychology, University of Sydney, Faculty of Science, Sydney, New South Wales, Australia.
⁶ Gynaecological Cancer Research, The University of Queensland, Brisbane, Queensland, Australia.
⁷ NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.
⁸ Psycho-oncology Co-operative Research Group (PoCoG), School of Psychology, University of Sydney, Sydney, New South Wales, Australia.
⁹ Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), School of Psychology, The University of Sydney, Sydney, New South Wales, Australia.
¹⁰ Australia and New Zealand Gynaecological Oncology Group, Sydney, New South Wales, Australia.
¹¹ Faculty of Health, Centre for Healthcare Transformation, Queensland University of Technology, Brisbane, Queensland, Australia.
¹² Department of Medical Oncology, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.
¹³ Bendat Family Comprehensive Cancer Centre, St John of God Subiaco Hospital, Subiaco, Western Australia, Australia.
¹⁴ Department of Oncology, Royal Brisbane & Women's Hospital, Herston, Queensland, Australia.
¹⁵ Faculty of Medicine, University of Queensland, St Lucia, Queensland, Australia.
¹⁶ Oncology and Dysplasia Unit, The Royal Women's Hospital, Melbourne, Victoria, Australia.
¹⁷ Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia.
¹⁸ Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
¹⁹ The Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Victoria, Australia.
²⁰ Cancer Services, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.
²¹ Ovarian Cancer Australia, Melbourne, Victoria, Australia.
²² Division of Surgery, The University of Western Australia Faculty of Health and Medical Sciences, Perth, Western Australia, Australia.
²³ Prince of Wales Clinical School, University of New South Wales, Randwick, New South Wales, Australia.
²⁴ Medical Oncology, Prince of Wales and Royal Hospital for Women, Randwick, New South Wales, Australia.
²⁵ Department of Gynaecological Oncology, Westmead Hospital, Sydney, New South Wales, Australia.
²⁶ Westmead Clinical School, University of Sydney, Sydney, New South Wales, Australia.
²⁷ Hunter New England Centre for Gynaecological Cancer, John Hunter Hospital, New Lambton Heights, New South Wales, Australia.
²⁸ Department of Gynaecological Oncology, St John of God Subiaco Hospital, Subiaco, Western Australia, Australia.
²⁹ Medical Oncology, Prince of Wales Hospital, Sydney, New South Wales, Australia.

PMID: 34551895
DOI: 10.1136/ijgc-2021-002999

Abstract

Background: Physical symptoms, anxiety, depression, fear of recurrence, sexual dysfunction, and social withdrawal are common in women after treatment for ovarian cancer. Most patients would like and need help dealing with these symptoms. The traditional model of follow-up care is unstructured and largely focused on diagnosing recurrent disease, and most oncologists lack skills to identify and manage psychosocial issues. No high quality prospective clinical trials have been conducted to determine the optimal follow-up regimen or the cost effectiveness of ovarian cancer surveillance strategies.

Primary objectives: To assess emotional wellbeing, acceptability, safety, and cost effectiveness of nurse led follow-up via telehealth for women with ovarian cancer following completion of primary treatment.

Study hypothesis: We hypothesize that compared with routine clinic based follow-up, nurse led follow-up via telehealth, including serum CA125 monitoring and completion of a patient reported outcome instrument, the Measure of Ovarian Symptoms and Treatment concerns-Surveillance (MOST-S26), will improve emotional wellbeing in women with ovarian cancer; be feasible, safe, acceptable, and not delay the time to diagnosis of recurrent disease; will result in greater patient satisfaction; will identify more patients with psychological distress, lead to better care, and improved psychological outcomes; and be cost-effective.

Trial design: Phase II multicenter randomized trial comparing 3 monthly nurse led telehealth consultations that include serum CA125 monitoring and completion of the MOST-S26, with routine clinic based follow-up. The allocation ratio will be 1:1.

Major inclusion/exclusion criteria: Eligible patients will be women with high grade epithelial ovarian cancer who have normalized serum CA125 (to <35 kU/L) at completion of first line chemotherapy.

Primary endpoints: Emotional wellbeing at 12 months.

Sample size: 150 patients.

Estimated dates for completing accrual and presenting results: July 2023. Results expected in 2025, 24 months after the last participant is enrolled.

Trial registration: ACTRN12620000332921.

Keywords: ovarian cancer; quality of life (PRO)/palliative care.

Publication types

Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Carcinoma, Ovarian Epithelial
Female
Follow-Up Studies
Humans
Nurse's Role
Ovarian Neoplasms* / drug therapy
Patient Reported Outcome Measures
Prospective Studies
Telemedicine*

Associated data

ANZCTR/ACTRN12620000332921