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.

Carcinoma, Ovarian Epithelial Female Follow-Up Studies Humans Nurse's Role Ovarian Neoplasms / drug therapy Patient Reported Outcome Measures Prospective Studies Telemedicine
ovarian cancer quality of life (PRO)/palliative care

Journal

International journal of gynecological cancer : official journal of the International Gynecological Cancer Society
ISSN: 1525-1438
Titre abrégé: Int J Gynecol Cancer
Pays: England
ID NLM: 9111626

Informations de publication

Date de publication:
04 04 2022
Historique:
pubmed: 24 9 2021
medline: 7 4 2022
entrez: 23 9 2021
Statut: epublish

Résumé

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. 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. 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. 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. 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. Emotional wellbeing at 12 months. 150 patients. July 2023. Results expected in 2025, 24 months after the last participant is enrolled. ACTRN12620000332921.

Sections du résumé

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.

Identifiants

DOI: 10.1136/ijgc-2021-002999 PMID: 34551895
pubmed: 34551895
pii: ijgc-2021-002999
doi: 10.1136/ijgc-2021-002999
doi:

Banques de données

ANZCTR
['ACTRN12620000332921']

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Pagination

560-565

Informations de copyright

© IGCS and ESGO 2022. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: PAC reports honoraria from Seqirus and Astra Zeneca unrelated to the submitted work. AO reports grants, personal fees, and other funding from SurgicalPerformance PTY Ltd, and grants from Medtronic, not directly related to the subject of this manuscript; consultancy fees from Baxter Healthcare Australia and New Zealand and Astra Zeneca Australia, not directly related to the subject of this manuscript; and a trademark licensed to SurgicalPerformance Pty Ltd. PB reports honoraria from GSK. MF reports grants from Astra Zeneca, Novartis, and Beigene; consulting fees from Astra Zeneca, Novartis, GSK, MSF, Takeda, and Lilly; honoraria from Astra Zeneca, GSK, and ACT Genomics; and support for travel from Astra Zeneca, unrelated to the submitted work. MK, MF, PMW, RC, and PAC developed the MOST-S26.

Auteurs

Paul A Cohen (PA)

Department of Gynaecological Oncology, St John of God Subiaco Hospital, Subiaco, Western Australia, Australia paul.cohen@uwa.edu.au.
Division of Obstetrics and Gynaecology, Faculty of Health and Medical Sciences, University of Western Australia, Perth, Western Australia, Australia.
Institute for Health Research, The University of Notre Dame Australia, Fremantle, Western Australia, Australia.
ORCID: 0000-0002-4860-9232

Penelope M Webb (PM)

Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia.

Madeleine King (M)

Faculty of Science, School of Psychology, University of Sydney, Faculty of Science, Sydney, New South Wales, Australia.

Andreas Obermair (A)

Gynaecological Cancer Research, The University of Queensland, Brisbane, Queensland, Australia.

Val Gebski (V)

NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.

Phyllis Butow (P)

Psycho-oncology Co-operative Research Group (PoCoG), School of Psychology, University of Sydney, Sydney, New South Wales, Australia.
Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), School of Psychology, The University of Sydney, Sydney, New South Wales, Australia.

Rachael Morton (R)

NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.

Wanda Lawson (W)

Australia and New Zealand Gynaecological Oncology Group, Sydney, New South Wales, Australia.

Patsy Yates (P)

Faculty of Health, Centre for Healthcare Transformation, Queensland University of Technology, Brisbane, Queensland, Australia.

Rachel Campbell (R)

Faculty of Science, School of Psychology, University of Sydney, Faculty of Science, Sydney, New South Wales, Australia.

Tarek Meniawy (T)

Department of Medical Oncology, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.

Michelle McMullen (M)

Department of Medical Oncology, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.

Andrew Dean (A)

Bendat Family Comprehensive Cancer Centre, St John of God Subiaco Hospital, Subiaco, Western Australia, Australia.

Jeffrey Goh (J)

Department of Oncology, Royal Brisbane & Women's Hospital, Herston, Queensland, Australia.
Faculty of Medicine, University of Queensland, St Lucia, Queensland, Australia.

Orla McNally (O)

Oncology and Dysplasia Unit, The Royal Women's Hospital, Melbourne, Victoria, Australia.
Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia.

Linda Mileshkin (L)

Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
The Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Victoria, Australia.

Philip Beale (P)

Cancer Services, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.

Rhonda Beach (R)

Australia and New Zealand Gynaecological Oncology Group, Sydney, New South Wales, Australia.

Jane Hill (J)

Ovarian Cancer Australia, Melbourne, Victoria, Australia.

Cyril Dixon (C)

Ovarian Cancer Australia, Melbourne, Victoria, Australia.

Sue Hegarty (S)

Ovarian Cancer Australia, Melbourne, Victoria, Australia.

Jim Codde (J)

Institute for Health Research, The University of Notre Dame Australia, Fremantle, Western Australia, Australia.

Angela Ives (A)

Division of Surgery, The University of Western Australia Faculty of Health and Medical Sciences, Perth, Western Australia, Australia.

Yeh Chen Lee (YC)

Prince of Wales Clinical School, University of New South Wales, Randwick, New South Wales, Australia.
Medical Oncology, Prince of Wales and Royal Hospital for Women, Randwick, New South Wales, Australia.

Alison Brand (A)

Department of Gynaecological Oncology, Westmead Hospital, Sydney, New South Wales, Australia.
Westmead Clinical School, University of Sydney, Sydney, New South Wales, Australia.

Anne Mellon (A)

Hunter New England Centre for Gynaecological Cancer, John Hunter Hospital, New Lambton Heights, New South Wales, Australia.

Sanela Bilic (S)

Department of Gynaecological Oncology, St John of God Subiaco Hospital, Subiaco, Western Australia, Australia.

Isobel Black (I)

Department of Gynaecological Oncology, St John of God Subiaco Hospital, Subiaco, Western Australia, Australia.

Stephanie Jeffares (S)

Department of Gynaecological Oncology, St John of God Subiaco Hospital, Subiaco, Western Australia, Australia.

Michael Friedlander (M)

Prince of Wales Clinical School, University of New South Wales, Randwick, New South Wales, Australia.
Medical Oncology, Prince of Wales Hospital, Sydney, New South Wales, Australia.
ORCID: 0000-0003-3090-795X

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Classifications MeSH

questionsmedicales.fr › Maladies endocriniennes › Troubles gonadiques › Maladies ovariennes › Tumeurs de l'ovaire › Carcinome épithélial de l'ovaire › Getting the MOST out of follow-up: a...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études de suivi › Getting the MOST out of follow-up: a...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Getting the MOST out of follow-up: a...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Prestations des soins de santé › Attitude du personnel soignant › Rôle de l'infirmier › Getting the MOST out of follow-up: a...
questionsmedicales.fr › Maladies endocriniennes › Troubles gonadiques › Maladies ovariennes › Tumeurs de l'ovaire › Getting the MOST out of follow-up: a...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Collecte de données › Enquêtes et questionnaires › Enquêtes sur les soins de santé › Mesures des résultats rapportés par les patients › Getting the MOST out of follow-up: a...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études prospectives › Getting the MOST out of follow-up: a...
questionsmedicales.fr › Administration des services de santé › Gestion des soins aux patients › Télémédecine › Getting the MOST out of follow-up: a...