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The Women’s Initiative for Sexual health, Education and Raising awareness of anal cancer (WISER)

The Women’s Initiative for Sexual health, Education and Raising awareness of anal cancer (WISER): an educational intervention to support sexual health in women with anal cancer

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000608369
Acronym
WISER
Enrollment
50
Registered
2026-05-15
Start date
2026-09-01
Completion date
2028-01-01
Last updated
2026-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Study background The WISER Study aims to investigate an educational intervention designed to support sexual health in women with anal cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or older, have been newly diagnosed with anal cancer (any stage), and are planned to receive chemoradiotherapy treatment. Study details All participants will receive a Women’s Initiative for Sexual health, Education and Raising awareness of anal cancer (WISER)-developed educational resource. This resource has been designed to address the sexual health, sexual function, and intimacy information needs of women with anal cancer. The resource will be provided by a healthcare professional (HCP) at the beginning of treatment and revisited during a follow-up consultation before the end of treatment. Feasibility and the impact of the information on patient needs, sexual health, and quality of life will be assessed in participants for up to 6 months after treatment begins. The impact of WISER on HCP awareness and confidence in discussing the sexual health effects of anal cancer treatment will also be evaluated at the end of the study. It is anticipated that this research will contribute to improved supportive care by addressing unmet sexual health information needs and enhancing person-centred care for women with anal cancer.

Interventions

What is the intervention? The WISER intervention includes a 60-page A5 information resource tailored to address the sexual health, sexual function and intimacy (SFI) information needs of women with anal cancer. The resource includes practical information about vaginal dilators, lubricants, and moisturisers, and shares real-life accounts of women’s experiences of anal cancer treatment. Who delivers it and their relevant expertise? The intervention will be delivered by healthcare professionals (H

What is the intervention? The WISER intervention includes a 60-page A5 information resource tailored to address the sexual health, sexual function and intimacy (SFI) information needs of women with anal cancer. The resource includes practical information about vaginal dilators, lubricants, and moisturisers, and shares real-life accounts of women’s experiences of anal cancer treatment. Who delivers it and their relevant expertise? The intervention will be delivered by healthcare professionals (HCP), which is anticipated to be primarily radiation oncology nurses. Each site will receive implementation training prior to recruitment. Recognising variability across care settings and professional roles, the WISER implementation training has been developed to support integration of the information booklet into existing clinical workflows, promote confidence among clinicians when introducing and revisiting the booklet, encourage consistent messaging while allowing flexibility in delivery, and reinforce safe practice, scope of practice boundaries, and referral pathways. HCPs who will be involved in the delivery of the WISER intervention will be asked to attend an in-person workshop lasting for a duration of up to 30 mins. Implementation training will be delivered by appropriately trained and qualified members of the Project Management Team prior to recruitment commencing (reflecting staggered recruitment across sites). All participating sites will have access to the implementation materials via an online education platform (Canvas) hosted by the University of Sydney. This platform will allow clinicians to revisit content and access materials as needed throughout the study period, which may be helpful when onboarding new site staff. How it is delivered? Face to face delivery, individually in the clinical setting. How often and for how long? The booklet will be provided on one occasion prior to patient participants starting radiotherapy treatment, and revisited at least once prior to the end of 6-8 weeks of treatment. The booklet will initially be provided in a routine appointment lasting up to 45 mins (but may vary depending on treatment location and schedule). It is expected that when the booklet is revisited, it will be at the time of a usual treatment or review appointment lasting approximately 30 mins. Where it is delivered? Clinically in the day therapy or radiation oncology unit (usual care). Adherence As this is a feasibility study, engagement with the booklet will be monitored by site staff (HCPs), and qualitative information will be collected from patient participants at follow up to determine how often they referred to the booklet during and after their treatment.

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Two study groups will be recruited: Adult women (18 or more years old) newly diagnosed with anal cancer (any stage) and planned to receive definitive chemoradiotherapy treatment at participating sites. HCPs directly involved in the care of patients diagnosed with anal cancer at participating sites involved in delivering patient information and education, including nurses, radiation oncologists, and other cancer specialists.

Exclusion criteria

Adult women younger than 18, with any cancer other than anal cancer. HCPs (men and women) will only be recruited through participating sites.

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026