SPICE: Supporting Sexual Health in Bladder Cancer Patients: A Sequential Mixed-Methods Intervention Study


Condition: Bladder Cancer, Non-Muscle-Invasive Bladder Cancer (NMIBC), Muscle-Invasive Bladder Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07339761

Sponsor: University of Aarhus

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • study 1a:
  • The participant has one of the following diagnoses and received initial treatment approximately 12 months ago: 1. Non-muscle-invasive bladder cancer treated with transurethral resection of the bladder (TUR-B) 2. Non-muscle-invasive bladder cancer treated with TUR-B and subsequent intravesical instillation therapy with chemotherapy or immunotherapy 3. Muscle-invasive bladder cancer treated with cystectomy (removal of the bladder)
  • The participant has experienced changes and/or difficulties in sexual function related to the cancer diagnosis and/or its treatment
  • The participant speaks and understands Danish
  • The participant is aged 18 years or older
  • The participant has read and understood the oral and written study information
  • The participant has provided written informed consent Exclusion Criteria study 1a:
  • The participant has a history of other cancers located in the pelvic region, including rectal cancer, sarcomas, uterine cancer, cervical cancer, ovarian cancer, prostate cancer, or penile cancer
  • The participant has a history of breast cancer Inclusion Criteria study 1b:
  • The participant is diagnosed with Muscle-invasive bladder cancer treated with cystectomy (removal of the bladder)
  • The participant speaks and understands Danish
  • The participant is aged 18 years or older
  • The participant has read and understood the oral and written study information
  • The participant has provided written informed consent

Exclusion Criteria:

  • study 1a:
  • The participant has a history of other cancers located in the pelvic region, including rectal cancer, sarcomas, uterine cancer, cervical cancer, ovarian cancer, prostate cancer, or penile cancer
  • The participant has a history of breast cancer Inclusion Criteria study 1b:
  • The participant is diagnosed with Muscle-invasive bladder cancer treated with cystectomy (removal of the bladder)
  • The participant speaks and understands Danish
  • The participant is aged 18 years or older
  • The participant has read and understood the oral and written study information
  • The participant has provided written informed consent Exclusion Criteria study 1b:
  • The participant has a history of other cancers located in the pelvic region, including rectal cancer, sarcomas, uterine cancer, cervical cancer, ovarian cancer, prostate cancer, or penile cancer
  • The participant has a history of breast cancer

View trial on ClinicalTrials.gov