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The Women’s Health Initiative cancer survivorship clinic incorporating electronic patient-reported outcomes: a study protocol for the Linking You to Support and Advice (LYSA) randomized controlled trial
BACKGROUND: The improved survival rate for many cancers in high-income countries demands a coordinated multidisciplinary approach to survivorship care and service provision to ensure optimal patient outcomes and quality of life. This study assesses the feasibility of introducing a Women’s Health Ini...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9648029/ https://www.ncbi.nlm.nih.gov/pubmed/36357934 http://dx.doi.org/10.1186/s40814-022-01186-x |
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author | Kearns, Noreen Raigal-Aran, Laia O’Connell, Kate Davis, Andrea Bermingham, Katie O’Reilly, Seamus Collins, Dearbhaile C. Corrigan, Mark Coulter, John Cleary, Vicki Cushen, Samantha Flavin, Aileen Byrne, Fiona O’Grady, Aisling O’Neill, Deirdre Murphy, Aileen Dahly, Darren Palmer, Brendan Connolly, Roisin M. Hegarty, Josephine |
author_facet | Kearns, Noreen Raigal-Aran, Laia O’Connell, Kate Davis, Andrea Bermingham, Katie O’Reilly, Seamus Collins, Dearbhaile C. Corrigan, Mark Coulter, John Cleary, Vicki Cushen, Samantha Flavin, Aileen Byrne, Fiona O’Grady, Aisling O’Neill, Deirdre Murphy, Aileen Dahly, Darren Palmer, Brendan Connolly, Roisin M. Hegarty, Josephine |
author_sort | Kearns, Noreen |
collection | PubMed |
description | BACKGROUND: The improved survival rate for many cancers in high-income countries demands a coordinated multidisciplinary approach to survivorship care and service provision to ensure optimal patient outcomes and quality of life. This study assesses the feasibility of introducing a Women’s Health Initiative cancer survivorship clinic in Ireland. METHODS: The trial https://spcare.bmj.com/content/9/2/209.short comprises an intervention and control arm. Two hundred participants will be recruited. Key eligibility (1) women with early-stage hormone receptor-positive breast or gynecologic cancer (cervix or endometrial), within 12 months of completion of primary curative therapy, and (2) access to the Internet. The complex intervention comprises a nurse-led clinic targeting symptom management through a trigger alert system, utilizing electronic patient-reported outcome (ePRO) assessments at baseline, and 2, 4, 6, 8, 10, and 12 months. It also includes input from a dietitian monitoring diet and nutritional status. The control group will receive their usual care pathway standard of care and attend the cancer survivorship clinic and complete ePRO assessments at the start and end of the study. The primary endpoint (feasibility) includes the proportion of enrolled participants who complete baseline and follow-up ePRO surveys and partake in health professional consultations after ePRO data triggers. Secondary endpoints include changes in cancer-related symptom scores assessed by ePROs, health-related Quality of Life Questionnaire (QLQ) scores, Appraisal Self-Care Agency-R scores, and adjuvant endocrine therapy medication adherence. A process evaluation will capture the experiences of participation in the study, and the healthcare costs will be examined as part of the economic analysis. Ethical approval was granted in December 2020, with accrual commencing in March 2021. DISCUSSION: This protocol describes the implementation of a parallel arm randomized controlled trial (RCT) which examines the feasibility of delivering a Cancer Survivorship Clinic. The ePRO is an innovative symptom monitoring system which detects the treatment-related effects and provides individualized support for cancer survivors. The findings will provide direction for the implementation of future survivorship care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05035173. Retrospectively registered on September 5, 2021 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-022-01186-x. |
format | Online Article Text |
id | pubmed-9648029 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-96480292022-11-15 The Women’s Health Initiative cancer survivorship clinic incorporating electronic patient-reported outcomes: a study protocol for the Linking You to Support and Advice (LYSA) randomized controlled trial Kearns, Noreen Raigal-Aran, Laia O’Connell, Kate Davis, Andrea Bermingham, Katie O’Reilly, Seamus Collins, Dearbhaile C. Corrigan, Mark Coulter, John Cleary, Vicki Cushen, Samantha Flavin, Aileen Byrne, Fiona O’Grady, Aisling O’Neill, Deirdre Murphy, Aileen Dahly, Darren Palmer, Brendan Connolly, Roisin M. Hegarty, Josephine Pilot Feasibility Stud Study Protocol BACKGROUND: The improved survival rate for many cancers in high-income countries demands a coordinated multidisciplinary approach to survivorship care and service provision to ensure optimal patient outcomes and quality of life. This study assesses the feasibility of introducing a Women’s Health Initiative cancer survivorship clinic in Ireland. METHODS: The trial https://spcare.bmj.com/content/9/2/209.short comprises an intervention and control arm. Two hundred participants will be recruited. Key eligibility (1) women with early-stage hormone receptor-positive breast or gynecologic cancer (cervix or endometrial), within 12 months of completion of primary curative therapy, and (2) access to the Internet. The complex intervention comprises a nurse-led clinic targeting symptom management through a trigger alert system, utilizing electronic patient-reported outcome (ePRO) assessments at baseline, and 2, 4, 6, 8, 10, and 12 months. It also includes input from a dietitian monitoring diet and nutritional status. The control group will receive their usual care pathway standard of care and attend the cancer survivorship clinic and complete ePRO assessments at the start and end of the study. The primary endpoint (feasibility) includes the proportion of enrolled participants who complete baseline and follow-up ePRO surveys and partake in health professional consultations after ePRO data triggers. Secondary endpoints include changes in cancer-related symptom scores assessed by ePROs, health-related Quality of Life Questionnaire (QLQ) scores, Appraisal Self-Care Agency-R scores, and adjuvant endocrine therapy medication adherence. A process evaluation will capture the experiences of participation in the study, and the healthcare costs will be examined as part of the economic analysis. Ethical approval was granted in December 2020, with accrual commencing in March 2021. DISCUSSION: This protocol describes the implementation of a parallel arm randomized controlled trial (RCT) which examines the feasibility of delivering a Cancer Survivorship Clinic. The ePRO is an innovative symptom monitoring system which detects the treatment-related effects and provides individualized support for cancer survivors. The findings will provide direction for the implementation of future survivorship care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05035173. Retrospectively registered on September 5, 2021 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-022-01186-x. BioMed Central 2022-11-10 /pmc/articles/PMC9648029/ /pubmed/36357934 http://dx.doi.org/10.1186/s40814-022-01186-x Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Kearns, Noreen Raigal-Aran, Laia O’Connell, Kate Davis, Andrea Bermingham, Katie O’Reilly, Seamus Collins, Dearbhaile C. Corrigan, Mark Coulter, John Cleary, Vicki Cushen, Samantha Flavin, Aileen Byrne, Fiona O’Grady, Aisling O’Neill, Deirdre Murphy, Aileen Dahly, Darren Palmer, Brendan Connolly, Roisin M. Hegarty, Josephine The Women’s Health Initiative cancer survivorship clinic incorporating electronic patient-reported outcomes: a study protocol for the Linking You to Support and Advice (LYSA) randomized controlled trial |
title | The Women’s Health Initiative cancer survivorship clinic incorporating electronic patient-reported outcomes: a study protocol for the Linking You to Support and Advice (LYSA) randomized controlled trial |
title_full | The Women’s Health Initiative cancer survivorship clinic incorporating electronic patient-reported outcomes: a study protocol for the Linking You to Support and Advice (LYSA) randomized controlled trial |
title_fullStr | The Women’s Health Initiative cancer survivorship clinic incorporating electronic patient-reported outcomes: a study protocol for the Linking You to Support and Advice (LYSA) randomized controlled trial |
title_full_unstemmed | The Women’s Health Initiative cancer survivorship clinic incorporating electronic patient-reported outcomes: a study protocol for the Linking You to Support and Advice (LYSA) randomized controlled trial |
title_short | The Women’s Health Initiative cancer survivorship clinic incorporating electronic patient-reported outcomes: a study protocol for the Linking You to Support and Advice (LYSA) randomized controlled trial |
title_sort | women’s health initiative cancer survivorship clinic incorporating electronic patient-reported outcomes: a study protocol for the linking you to support and advice (lysa) randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9648029/ https://www.ncbi.nlm.nih.gov/pubmed/36357934 http://dx.doi.org/10.1186/s40814-022-01186-x |
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