{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T06:12:52Z","timestamp":1788502372371,"version":"build-2803163510"},"reference-count":53,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T00:00:00Z","timestamp":1788307200000},"content-version":"unspecified","delay-in-days":1,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher","award":["1R21CA279278-01A1"],"award-info":[{"award-number":["1R21CA279278-01A1"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,8,13]]},"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Younger female cancer survivors disproportionately suffer from treatment-related sexual dysfunction, yet evidence-based intervention for these prevalent and distressing side effects remains lacking. Previously, we developed and pilot-tested SHARE (Sexual Health and Rehabilitation), a single-session, in-person group educational intervention for younger female survivors with distressing sexual dysfunction. We recently adapted the intervention to be delivered via synchronous videoconference, now called SHAREonline. The aims of this optimisation trial are to (1) evaluate \u2018proof-of-concept\u2019, that is, clinically significant change in sexual function and psychological distress in younger female survivors, and (2) conduct pilot testing to assess feasibility of the intervention, including assessing the credibility of a control condition (ie, individual self-management (ISM)). Participant characteristics associated with clinically significant response to the intervention will also be explored to prepare for a larger efficacy trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This trial will enrol 84 female survivors, ages 19\u201349 with clinically significant treatment-related sexual dysfunction. Participants will be randomised to either the SHAREonline intervention or ISM. Sexual function and psychological distress are assessed at baseline, 8 and 16\u2009weeks postintervention. Outcomes will be assessed by evaluating change in sexual function and psychological distress from baseline to 8 weeks (primary endpoint), and feasibility, including credibility and acceptability of the control condition, will be evaluated. Postintervention qualitative interviews will be conducted to further explore the experience of trial participants. If findings are positive, we will next evaluate the efficacy of SHAREonline in a fully powered efficacy trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This trial has been registered on ClinicalTrials.gov. Ethical approval has been granted by Dana-Farber Cancer Institute\u2019s Institutional Review Board (4 January 2022) prior to data collection. Results will be published in peer-reviewed journals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06458049\">NCT06458049<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-111471","type":"journal-article","created":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T13:10:28Z","timestamp":1788441028000},"page":"e111471","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Sexual health and REhabilitation online (SHAREonline): study protocol of an optimisation trial"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct06458049","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06458049","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Eva Michaela","family":"Miklos","sequence":"first","affiliation":[{"name":"Perini Family Survivors\u2019 Center, Dana Farber Cancer Institute, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher J","family":"Recklitis","sequence":"additional","affiliation":[{"name":"Perini Family Survivors\u2019 Center, Dana Farber Cancer Institute, Boston, Massachusetts, USA"},{"name":"Harvard Medical School, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer Barsky","family":"Reese","sequence":"additional","affiliation":[{"name":"Temple Health, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA"},{"name":"Department of Social and Behavioral Sciences, Temple University College of Public Health, Philadelphia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheryl","family":"Medeiros-Nancarrow","sequence":"additional","affiliation":[{"name":"Perini Family Survivors\u2019 Center, Dana Farber Cancer Institute, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2793-2620","authenticated-orcid":false,"given":"Sharon L","family":"Bober","sequence":"additional","affiliation":[{"name":"Perini Family Survivors\u2019 Center, Dana Farber Cancer Institute, Boston, Massachusetts, USA"},{"name":"Harvard Medical School, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,9,2]]},"reference":[{"key":"2026090322301524000_16.9.e111471.1","doi-asserted-by":"crossref","first-page":"2529","DOI":"10.1002\/cncr.29466","article-title":"The importance of assessing priorities of reproductive health concerns among adolescent and young adult patients with cancer","volume":"121","author":"Murphy","year":"2015","journal-title":"Cancer"},{"key":"2026090322301524000_16.9.e111471.2","doi-asserted-by":"crossref","first-page":"2770","DOI":"10.1002\/pon.4886","article-title":"Sexual dysfunction and reproductive concerns in young women with breast cancer: Type, prevalence, and predictors of problems","volume":"27","author":"Ljungman","year":"2018","journal-title":"Psychooncology"},{"key":"2026090322301524000_16.9.e111471.3","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.04.2499"},{"key":"2026090322301524000_16.9.e111471.4","doi-asserted-by":"crossref","DOI":"10.1001\/jamanetworkopen.2023.43910","article-title":"Chemotherapy-Related Amenorrhea and Quality of Life Among Premenopausal Women With Breast Cancer","volume":"6","author":"Kabirian","year":"2023","journal-title":"JAMA Netw Open"},{"key":"2026090322301524000_16.9.e111471.5","doi-asserted-by":"publisher","DOI":"10.1002\/pon.744"},{"key":"2026090322301524000_16.9.e111471.6","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2007.14.1655"},{"key":"2026090322301524000_16.9.e111471.7","doi-asserted-by":"crossref","first-page":"110","DOI":"10.1016\/j.breast.2021.06.012","article-title":"Long-term health-related quality of life of breast cancer survivors remains impaired compared to the age-matched general population especially in young women. 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