Title: SPICE

Aim: To develop and evaluate a sexological intervention for bladder cancer patients in order to improve sexual health care and patient wellbeing.

Methods: 
This study consists of two sequential sub-studies:

• Study 1a (Development phase): A qualitative, exploratory study to develop a sexological intervention with patient and clinician involvement.
• Study 1b (Feasibility phase): A randomized controlled feasibility trial assessing the implementation and acceptability of the intervention among patients with muscle invasive bladder cancer (MIBC).

Study 1a – Development phase

A qualitative study will be conducted including 30 patients (both genders) recruited from the Department of Urology at Aarhus University Hospital and Gødstrup Hospital. Patients will be sampled to represent three subgroups (n=10 each):

1. Muscle invasive bladder cancer (MIBC) treated with cystectomy
2. Non–muscle invasive bladder cancer (NMIBC) treated with TUR-B only
3. Non–muscle invasive bladder cancer (NMIBC) treated with TUR-B and intravesical instillation therapy

Patients will be invited to participate in semi-structured interviews. Interview transcripts will be analyzed using an inductive qualitative approach. Findings will be used to identify which factors patients consider important in sexual health care, including preferences for timing, content, format (face-to-face, written, video), and partner involvement. A draft intervention will be developed based on these insights and refined through discussion with an expert panel (clinicians in sexology and urology) and subsequent feedback from a patient panel (n=6). The final intervention will then serve as the basis for Study 1b.

Study 1b – Feasibility phase

A two-arm randomized controlled feasibility trial will be conducted to evaluate implementation of the intervention. Patients are eligible if they are:

• ≥18 years old, male or female
• able to read and speak Danish
• diagnosed with MIBC scheduled for cystectomy at the Department of Urology, Aarhus University Hospital.

Patients will be recruited at their first visit to the urostomy clinic prior to surgery. After obtaining informed consent and baseline data, participants will be randomized 1:1 using REDCap to one of two study arms:

1. Usual care
2. Sexological counselling intervention (delivered according to insights from Study 1a, including timing and potential partner involvement)

Follow-up will take place at ~4 months post-surgery (timing adjusted based on Study 1a), with additional assessments at 1 year and 5 years. Data collection will include primary endpoints assessing feasibility (recruitment, adherence, retention, response rates) and secondary endpoints assessing patient-reported outcomes (PROMs).

Number of patients:
Study 1a: 30 patients (10 per subgroup). 
Study 1b: 40 patients (20 per arm).

Sites: 
Dept. of Urology, Aarhus University Hospital
Dept. of Urology, Gødstrup Hospital