Sexual health and REhabilitation online (SHAREonline): study protocol of an optimisation trial

Vollständiger Abstract

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Introduction 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 ‘proof-of-concept’, 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. Methods and analysis This trial will enrol 84 female survivors, ages 19–49 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 weeks 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. Ethics and dissemination This trial has been registered on ClinicalTrials.gov. Ethical approval has been granted by Dana-Farber Cancer Institute’s Institutional Review Board (4 January 2022) prior to data collection. Results will be published in peer-reviewed journals. Trial registration number NCT06458049 .