{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,14]],"date-time":"2026-06-14T05:12:03Z","timestamp":1781413923356,"version":"3.54.1"},"reference-count":57,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2024,3,23]],"date-time":"2024-03-23T00:00:00Z","timestamp":1711152000000},"content-version":"unspecified","delay-in-days":22,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["APP2006528"],"award-info":[{"award-number":["APP2006528"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,2,20]]},"published-print":{"date-parts":[[2024,3]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Androgen deprivation therapy (ADT) is commonly used to treat men with locally advanced or metastatic prostate cancer. Men receiving ADT experience numerous side effects and frequently report unmet supportive care needs. An essential part of quality cancer care is survivorship care. To date, an optimal effective approach to survivorship care for men with prostate cancer on ADT has not been described. This protocol describes a randomised trial of tele-based nurse-led survivorship that addresses this knowledge gap: (1) determine the effectiveness of a nurse-led survivorship care intervention (PCEssentials), relative to usual care, for improving health-related quality of life (HR-QoL) in men with prostate cancer undergoing ADT and (2) evaluate PCEssentials implementation strategies and outcomes, including cost-effectiveness, compared with usual care.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This is an effectiveness-implementation hybrid (type 1) trial with participants randomised to one of two arms: (1) minimally enhanced usual care and (2) nurse-led prostate cancer survivorship essentials (PCEssentials) delivered over four tele-based sessions, with a booster session 5\u2009months after session 1. Eligible participants are Australian men with prostate cancer commencing ADT and expected to be on ADT for a minimum of 12 months. Participants are followed up at 3, 6 and 12\u2009months postrecruitment. Primary outcomes are HR-QoL and self-efficacy. Secondary outcomes are psychological distress, insomnia, fatigue and physical activity. A concurrent process evaluation with participants and study stakeholders will be undertaken to determine effectiveness of delivery of PCEssentials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethics approval was obtained from the Metro South Health HREC (HREC\/2021\/QMS\/79429). All participants are required to provide written informed consent. Outcomes of this trial will be published in peer-reviewed journals. The findings will be presented at conferences and meetings, local hospital departments, participating organisations\/clinical services, and university seminars, and communicated at community and consumer-led forums.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>ACTRN12622000025730.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-084412","type":"journal-article","created":{"date-parts":[[2024,3,23]],"date-time":"2024-03-23T12:41:06Z","timestamp":1711197666000},"page":"e084412","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":5,"title":["Prostate Cancer Survivorship Essentials for men with prostate cancer on androgen deprivation therapy: protocol for a randomised controlled trial of a tele-based nurse-led survivorship care intervention (PCEssentials Hormone Therapy Study)"],"prefix":"10.1136","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7541-3665","authenticated-orcid":false,"given":"Anna","family":"Green","sequence":"first","affiliation":[{"name":"Centre for Health Research, University of Southern Queensland, Springfield Central, Queensland, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0302-6129","authenticated-orcid":false,"given":"Robert U","family":"Newton","sequence":"additional","affiliation":[{"name":"Exercise Medicine Research Institute, Edith Cowan University, Joondalup, Western Australia, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1474-3214","authenticated-orcid":false,"given":"David P","family":"Smith","sequence":"additional","affiliation":[{"name":"The Daffodil Centre, a joint venture with Cancer Council NSW, The University of Sydney, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2993-3480","authenticated-orcid":false,"given":"Haitham","family":"Tuffaha","sequence":"additional","affiliation":[{"name":"The University of Queensland, Saint Lucia, Queensland, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8209-2281","authenticated-orcid":false,"given":"Daniel A","family":"Galv\u00e3o","sequence":"additional","affiliation":[{"name":"Exercise Medicine Research Institute, Edith Cowan University, Joondalup, Western Australia, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Heathcote","sequence":"additional","affiliation":[{"name":"Brisbane Urology Clinic, Brisbane, Queensland, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1409-9171","authenticated-orcid":false,"given":"Manish I","family":"Patel","sequence":"additional","affiliation":[{"name":"University of Sydney, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5494-8751","authenticated-orcid":false,"given":"David","family":"Christie","sequence":"additional","affiliation":[{"name":"Genesiscare, Tugun, Queensland, Australia"},{"name":"Bond University, Robina, Queensland, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1808-6909","authenticated-orcid":false,"given":"Sam","family":"Egger","sequence":"additional","affiliation":[{"name":"The Daffodil Centre, a joint venture with Cancer Council NSW, The University of Sydney, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9268-5331","authenticated-orcid":false,"given":"Sally AM","family":"Sara","sequence":"additional","affiliation":[{"name":"Prostate Cancer Foundation of Australia, St Leonards, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8102-1871","authenticated-orcid":false,"given":"Nicole","family":"Heneka","sequence":"additional","affiliation":[{"name":"Centre for Health Research, University of Southern Queensland, Springfield Central, Queensland, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2369-6111","authenticated-orcid":false,"given":"Suzanne K","family":"Chambers","sequence":"additional","affiliation":[{"name":"Australian Catholic University, Brisbane, Queensland, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1180-3381","authenticated-orcid":false,"given":"Jeff","family":"Dunn","sequence":"additional","affiliation":[{"name":"Centre for Health Research, University of Southern Queensland, Springfield Central, Queensland, Australia"},{"name":"Prostate Cancer Foundation of Australia, St Leonards, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2024,3,23]]},"reference":[{"key":"2025121410204974000_14.3.e084412.1","unstructured":"Australian Institute of Health and Welfare . Cancer data in Australia. 2023. Available: https:\/\/www.aihw.gov.au\/reports\/cancer\/cancer-data-in-australia\/contents\/overview-of-cancer-in-australia-2023"},{"key":"2025121410204974000_14.3.e084412.2","doi-asserted-by":"publisher","DOI":"10.1002\/pon.5255"},{"key":"2025121410204974000_14.3.e084412.3","doi-asserted-by":"crossref","first-page":"2169","DOI":"10.1002\/pon.3269","article-title":"Predictors of depression, anxiety and quality of life in patients with prostate cancer receiving androgen deprivation therapy","volume":"22","author":"Chipperfield","year":"2013","journal-title":"Psychooncology"},{"key":"2025121410204974000_14.3.e084412.4","doi-asserted-by":"crossref","first-page":"999","DOI":"10.1002\/phar.2168","article-title":"Risks of major long-term side effects associated with androgen-deprivation therapy in men with prostate cancer","volume":"38","author":"Nguyen","year":"2018","journal-title":"Pharmacotherapy"},{"key":"2025121410204974000_14.3.e084412.5","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.m3503","article-title":"Fifteen year quality of life outcomes in men with Localised prostate cancer: population based Australian prospective study","volume":"371","author":"Mazariego","year":"2020","journal-title":"BMJ"},{"key":"2025121410204974000_14.3.e084412.6","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.b4817","article-title":"Quality of life three years after diagnosis of Localised prostate cancer: population based cohort study","volume":"339","author":"Smith","year":"2009","journal-title":"BMJ"},{"key":"2025121410204974000_14.3.e084412.7","doi-asserted-by":"publisher","DOI":"10.1038\/aja.2011.108"},{"key":"2025121410204974000_14.3.e084412.8","first-page":"2079","article-title":"Incidence of the adverse effects of androgen deprivation therapy for prostate cancer: a systematic literature review","volume":"28","author":"Edmunds","year":"2020","journal-title":"Support Care Cancer"},{"key":"2025121410204974000_14.3.e084412.9","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1111\/bju.12964","article-title":"Adverse effects of androgen-deprivation therapy in prostate cancer and their management","volume":"115 Suppl 5","author":"Rhee","year":"2015","journal-title":"BJU Int"},{"key":"2025121410204974000_14.3.e084412.10","unstructured":"Australian Cancer Network Management of Metastatic Prostate Cancer Working Party . Clinical Practice Guidelines for the Management of Locally Advanced and Metastatic Prostate Cancer. Sydney: Cancer Council Australia and Australian Cancer Network, 2010."},{"key":"2025121410204974000_14.3.e084412.11","doi-asserted-by":"crossref","first-page":"403","DOI":"10.1038\/s41391-018-0036-y","article-title":"Development of Comorbidities in men with prostate cancer treated with androgen deprivation therapy: an Australian population-based cohort study","volume":"21","author":"Ng","year":"2018","journal-title":"Prostate Cancer Prostatic Dis"},{"key":"2025121410204974000_14.3.e084412.12","doi-asserted-by":"crossref","DOI":"10.1016\/j.soncn.2020.151049","article-title":"Experiences of unmet need and access to supportive care for men receiving androgen Depriviation therapy for prostate cancer: A bi-national study","volume":"36","author":"Paterson","year":"2020","journal-title":"Semin Oncol Nurs"},{"key":"2025121410204974000_14.3.e084412.13","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2013-003901","article-title":"Depression and anxiety in prostate cancer: a systematic review and meta-analysis of prevalence rates","volume":"4","author":"Watts","year":"2014","journal-title":"BMJ Open"},{"key":"2025121410204974000_14.3.e084412.14","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2012.12.018"},{"key":"2025121410204974000_14.3.e084412.15","doi-asserted-by":"crossref","first-page":"497","DOI":"10.1097\/NCC.0000000000000482","article-title":"Unmet supportive care needs of men with locally advanced and metastatic prostate cancer on hormonal treatment: A mixed methods study","volume":"40","author":"Paterson","year":"2017","journal-title":"Cancer Nurs"},{"key":"2025121410204974000_14.3.e084412.16","first-page":"5511","article-title":"Long-term unmet supportive care needs of prostate cancer survivors: 15-year follow-up from the NSW prostate cancer care and outcomes study","volume":"28","author":"Mazariego","year":"2020","journal-title":"Support Care Cancer"},{"key":"2025121410204974000_14.3.e084412.17","first-page":"2755","article-title":"The experiences of men receiving androgen deprivation treatment for prostate cancer: a qualitative study","volume":"12","author":"Gray","year":"2005","journal-title":"Can J Urol"},{"key":"2025121410204974000_14.3.e084412.18","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21234"},{"key":"2025121410204974000_14.3.e084412.19","doi-asserted-by":"crossref","first-page":"83","DOI":"10.1016\/j.urolonc.2019.10.006","article-title":"Improving research for prostate cancer survivorship: A statement from the survivorship research in prostate cancer (Surecap) working group","volume":"38","author":"Narayan","year":"2020","journal-title":"Urol Oncol"},{"key":"2025121410204974000_14.3.e084412.20","doi-asserted-by":"crossref","first-page":"557","DOI":"10.1002\/pon.5306","article-title":"Contemporary consumer perspectives on prostate cancer survivorship: fifty voices","volume":"29","author":"Dunn","year":"2020","journal-title":"Psycho-Oncology"},{"key":"2025121410204974000_14.3.e084412.21","doi-asserted-by":"crossref","DOI":"10.1186\/s40900-017-0070-2","article-title":"Patient involvement in guidelines is poor five years after Institute of medicine standards: review of guideline Methodologies","volume":"3","author":"Armstrong","year":"2017","journal-title":"Res Involv Engagem"},{"key":"2025121410204974000_14.3.e084412.22","doi-asserted-by":"crossref","first-page":"2339","DOI":"10.1002\/pon.4888","article-title":"Interventions for prostate cancer survivorship: A systematic review if reviews","volume":"27","author":"Crawford-Williams","year":"2018","journal-title":"Psychooncology"},{"key":"2025121410204974000_14.3.e084412.23","doi-asserted-by":"crossref","first-page":"18","DOI":"10.1111\/bju.15159","article-title":"Prostate cancer survivorship essentials framework: guidelines for practitioners","volume":"128","author":"Dunn","year":"2021","journal-title":"BJU International"},{"key":"2025121410204974000_14.3.e084412.24","doi-asserted-by":"publisher","DOI":"10.1097\/MLR.0b013e3182408812"},{"key":"2025121410204974000_14.3.e084412.25","doi-asserted-by":"publisher","DOI":"10.1007\/s10488-010-0319-7"},{"key":"2025121410204974000_14.3.e084412.26","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-134-8-200104170-00012"},{"key":"2025121410204974000_14.3.e084412.27","unstructured":"The National Health and Medical Research Council, The Australian Research Council, Universities Australia . National Statement in Ethical Conduct in Human Research 2007. Canberra: Commonwealth of Australia, 2007."},{"key":"2025121410204974000_14.3.e084412.28","unstructured":"The National Health and Medical Research Council, The Australian Research Council, Universities Australia . Australian Code for the Responsible Conduct of Research 2018. Canberra: Commonwealth of Australia, 2018."},{"key":"2025121410204974000_14.3.e084412.29","doi-asserted-by":"crossref","DOI":"10.1186\/1471-2407-8-207","article-title":"Proscan for men: randomised controlled trial of a decision support intervention for men with Localised prostate cancer","volume":"8","author":"Chambers","year":"2008","journal-title":"BMC Cancer"},{"key":"2025121410204974000_14.3.e084412.30","doi-asserted-by":"crossref","first-page":"748","DOI":"10.1002\/pon.3726","article-title":"A randomised controlled trial of a couples-based sexuality intervention for men with Localised prostate cancer and their female partners","volume":"24","author":"Chambers","year":"2015","journal-title":"Psychooncology"},{"key":"2025121410204974000_14.3.e084412.31","doi-asserted-by":"crossref","first-page":"412","DOI":"10.1097\/NCC.0000000000000432","article-title":"Health-related quality of life after diagnosis of locally-advanced or advanced prostate cancer: A longitudinal study","volume":"40","author":"Zajdlewicz","year":"2017","journal-title":"Cancer Nurs"},{"key":"2025121410204974000_14.3.e084412.32","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1007\/s40501-013-0003-0","article-title":"Problem-solving therapy in the elderly","volume":"1","author":"Kiosses","year":"2014","journal-title":"Curr Treat Options Psychiatry"},{"key":"2025121410204974000_14.3.e084412.33","doi-asserted-by":"publisher","DOI":"10.1007\/s10865-005-4664-z"},{"key":"2025121410204974000_14.3.e084412.34","doi-asserted-by":"crossref","first-page":"228","DOI":"10.1037\/men0000018","article-title":"Measuring masculinity in the context of chronic disease","volume":"17","author":"Chambers","year":"2015","journal-title":"Psychol Men Mascul"},{"key":"2025121410204974000_14.3.e084412.35","unstructured":"Chambers S . Facing the Tiger: A Survivorship Guide for Men with Prostate Cancer and their Partners. Brisbane, Australia: Australian Academic Press, 2020."},{"key":"2025121410204974000_14.3.e084412.36","doi-asserted-by":"crossref","first-page":"195","DOI":"10.1002\/pon.3391","article-title":"The validity of the distress thermometer in prostate cancer populations","volume":"23","author":"Chambers","year":"2014","journal-title":"Psychooncology"},{"key":"2025121410204974000_14.3.e084412.37","doi-asserted-by":"crossref","first-page":"1175","DOI":"10.1016\/j.jsams.2019.05.003","article-title":"The exercise and sports science Australia position statement: exercise medicine in cancer management","volume":"22","author":"Hayes","year":"2019","journal-title":"J Sci Med Sport"},{"key":"2025121410204974000_14.3.e084412.38","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1712502"},{"key":"2025121410204974000_14.3.e084412.39","doi-asserted-by":"crossref","first-page":"873","DOI":"10.1002\/pon.4431","article-title":"New challenges in psycho-oncology research III: A systematic review of psychological interventions for prostate cancer survivors and their partners: Clincial and research implications","volume":"26","author":"Chambers","year":"2017","journal-title":"Psychooncology"},{"key":"2025121410204974000_14.3.e084412.40","doi-asserted-by":"crossref","unstructured":"Weiner BJ , Lewis CC , Stanick C , et al . Psychometric assessment of three newly developed implementation outcome measures. Implementation Sci 2017;12. doi:10.1186\/s13012-017-0635-3","DOI":"10.1186\/s13012-017-0635-3"},{"key":"2025121410204974000_14.3.e084412.41","doi-asserted-by":"publisher","DOI":"10.1080\/10503300500352500"},{"key":"2025121410204974000_14.3.e084412.42","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1993.11.3.570"},{"key":"2025121410204974000_14.3.e084412.43","unstructured":"Richardson J , Elsworth G , Iezzi A , et al . Increasing the sensitivity of the AQoL inventory for evaluation of interventions affecting mental health. Melbourne, Australia: Monash University, Business and Economics, Centre for Health Economics, 2011."},{"key":"2025121410204974000_14.3.e084412.44","doi-asserted-by":"publisher","DOI":"10.1016\/S0895-4356(98)00081-X"},{"key":"2025121410204974000_14.3.e084412.45","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2009.23.2488"},{"key":"2025121410204974000_14.3.e084412.46","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1007\/s11764-014-0384-0","article-title":"Cancer survivors' self-efficacy to self-manage in the year following primary treatment","volume":"9","author":"Foster","year":"2015","journal-title":"J Cancer Surviv"},{"key":"2025121410204974000_14.3.e084412.47","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.166.10.1092"},{"key":"2025121410204974000_14.3.e084412.48","doi-asserted-by":"publisher","DOI":"10.1046\/j.1525-1497.2001.016009606.x"},{"key":"2025121410204974000_14.3.e084412.49","doi-asserted-by":"publisher","DOI":"10.1016\/S1389-9457(00)00065-4"},{"key":"2025121410204974000_14.3.e084412.50","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpainsymman.2003.06.003"},{"key":"2025121410204974000_14.3.e084412.51","first-page":"18","article-title":"The Godin-Shephard leisure-time physical activity questionnaire","volume":"4","author":"Godin","year":"2011","journal-title":"Health Fitness J Canada"},{"key":"2025121410204974000_14.3.e084412.52","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2021-058899","article-title":"Weight loss for overweight and obese patients with prostate cancer: a study protocol of a randomised trial comparing clinic-based versus Telehealth delivered exercise and nutrition intervention (the telex trial)","volume":"12","author":"Galv\u00e3o","year":"2022","journal-title":"BMJ Open"},{"key":"2025121410204974000_14.3.e084412.53","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2011.40.8922"},{"key":"2025121410204974000_14.3.e084412.54","doi-asserted-by":"publisher","DOI":"10.1177\/1049732305276687"},{"key":"2025121410204974000_14.3.e084412.55","doi-asserted-by":"publisher","DOI":"10.1370\/afm.1865"},{"key":"2025121410204974000_14.3.e084412.56","doi-asserted-by":"crossref","first-page":"944","DOI":"10.1016\/j.jval.2018.01.010","article-title":"Estimating future health technology diffusion using expert beliefs calibrated to an established diffusion model","volume":"21","author":"Grimm","year":"2018","journal-title":"Value Health"},{"key":"2025121410204974000_14.3.e084412.57","doi-asserted-by":"publisher","DOI":"10.1037\/0278-6133.23.5.443"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2024-084412","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T18:21:00Z","timestamp":1765736460000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2024-084412"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,3]]},"references-count":57,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2024,3,23]]},"published-print":{"date-parts":[[2024,3]]}},"alternative-id":["10.1136\/bmjopen-2024-084412"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2024-084412","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,3]]}}}