Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:20 AM
Study NCT ID:
NCT07339761
Status:
RECRUITING
Last Update Posted:
2026-01-14
First Post:
2025-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supporting Sexual Health in Bladder Cancer Patients: A Sequential Mixed-Methods Intervention Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D000093284', 'term': 'Non-Muscle Invasive Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '* Study 1a (Development phase): A qualitative, exploratory study to develop a sexological intervention with patient and clinician involvement.\n* Study 1b (Feasibility phase): A one-armed feasibility trial assessing the implementation and acceptability of the intervention among patients with muscle-invasive bladder cancer (MIBC).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-05', 'studyFirstSubmitDate': '2025-12-10', 'studyFirstSubmitQcDate': '2026-01-05', 'lastUpdatePostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study 1a: Patient-perceived sexual health challenges identified through semi-structured qualitative interviews', 'timeFrame': '1 year', 'description': 'Patient perceptions of sexual health challenges will be explored through semi-structured individual interviews. Interviews will be audio-recorded, transcribed verbatim, and analyzed using thematic analysis. Results will be reported as descriptive themes representing common challenges across participants.'}, {'measure': 'Study 1a: Patient informational needs regarding sexual health identified through semi-structured qualitative interviews', 'timeFrame': '1 year', 'description': 'Patient informational needs related to sexual health will be assessed through semi-structured individual interviews. Interview transcripts will be analyzed using thematic analysis, and results will be reported as themes describing shared informational needs.'}, {'measure': 'Study 1a: Patient preferences for professional sexual health support identified through semi-structured qualitative interviews', 'timeFrame': '1 year', 'description': 'Patient preferences for professional sexual health support will be explored using semi-structured individual interviews. Data will be analyzed using thematic analysis, and findings will be reported as themes describing preferred type, timing, and format of support.'}, {'measure': 'Study 1b: Recruitment rate', 'timeFrame': '2 years', 'description': 'Recruitment rate will be defined as the number of participants enrolled divided by the number of eligible participants approached during the recruitment period.'}, {'measure': 'Study 1b: Retention rate', 'timeFrame': '2 years', 'description': 'Retention rate will be defined as the proportion of enrolled participants who complete all required study assessments.'}, {'measure': 'Study 1b: Adherence to study protocol', 'timeFrame': '2 years', 'description': 'Protocol adherence will be assessed as the proportion of participants who complete the intervention according to the predefined study procedures.'}, {'measure': 'Study 1b: Response rate to patient-reported outcome measures', 'timeFrame': '2 years', 'description': 'Response rate will be defined as the proportion of completed patient-reported outcome questionnaires out of the total number of questionnaires distributed.'}, {'measure': 'Study 1b: Data completeness of patient-reported outcome measures', 'timeFrame': '2 years', 'description': 'Data completeness will be assessed as the proportion of fully completed items across all patient-reported outcome measures.'}], 'secondaryOutcomes': [{'measure': 'Study 1b: Sexual function assessed by the Female Sexual Function Index (FSFI)', 'timeFrame': '2 years', 'description': 'Sexual function will be assessed using the Female Sexual Function Index (FSFI). The total score ranges from 2 to 36, with higher scores indicating better sexual function.'}, {'measure': 'Study 1b: Sexual distress assessed by the Female Sexual Distress Scale-Revised (FSDS-R)', 'timeFrame': '2 years', 'description': 'Sexual distress will be measured using the Female Sexual Distress Scale-Revised (FSDS-R). Total scores range from 0 to 52, with higher scores indicating greater sexual distress.'}, {'measure': 'Study 1b: Wellbeing assessed by the WHO-5 Well-Being Index', 'timeFrame': '2 years', 'description': 'Wellbeing will be assessed using the WHO-5 Well-Being Index. Scores range from 0 to 100, with higher scores indicating better wellbeing.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sexual Health', 'Bladder Cancer', 'Sexual Rehabilitation'], 'conditions': ['Bladder Cancer', 'Non-Muscle-Invasive Bladder Cancer (NMIBC)', 'Muscle-Invasive Bladder Carcinoma']}, 'descriptionModule': {'briefSummary': 'Despite increasing recognition of sexual dysfunction and sexual distress as important survivorship issues in oncology, research and clinical attention remain uneven across cancer types. This imbalance is particularly evident in bladder cancer, where sexual health has received limited research and clinical attention. However, existing studies demonstrate substantial sexual dysfunction and reduced intimacy among patients following disease and treatment.\n\nThe treatment of bladder cancer is a multimodal and multidisciplinary discipline. Low-risk non-muscle-invasive bladder cancer (NMIBC) is treated by transurethral resection of the bladder (TURB) alone, while recurrent intermediate- and high-risk NMIBC undergo a combination of TURB and adjuvant intravesical instillation therapy. For patients with muscle-invasive bladder cancer (MIBC) and specific high-risk NMIBC cases, the first-line treatment option is radical cystectomy with urinary diversion, with or without neoadjuvant chemotherapy.\n\nThese treatment modalities are known to have a negative impact on sexual function, and studies in both men and women demonstrate profound impairments in sexual function, intimacy, and body image after treatment. Among men, erectile and ejaculatory dysfunction are prevalent for this patient group and frequently associated with diminished sexual satisfaction and body-image concerns. Likewise, women experience loss of sexual desire, orgasmic disorders, dyspareunia, and vaginal dryness following cystectomy.\n\nA targeted literature search further identified no contemporary sexology-focused interventional or feasibility trials specifically in bladder cancer (neither MIBC or NMIBC). Existing evidence on the topic is largely descriptive or addresses non-sexological rehabilitation, demonstrating a evidence gap\\[1\\].\n\nQualitative research has also explored informational and psychosocial needs among bladder cancer patients, revealing limited communication about sexual health and unmet needs for professional support. Such studies provide valuable insight into patient experiences but have not yet translated this knowledge into the development of structured, sexological interventions.\n\nEvidence from other cancer populations demonstrates that counselling and psychoeducational programmes addressing intimacy and sexuality are both feasible and beneficial, suggesting that similar interventions could be adapted for bladder cancer care.\n\nTo develop a relevant and acceptable intervention, it is essential to understand how patients themselves perceive their sexual health challenges, informational needs, and preferences for professional support regarding sexual health.\n\nThis project therefore consists of two sequential sub-studies:\n\n* Study 1a (Development phase): A qualitative, exploratory study to develop a sexological intervention with patient and clinician involvement.\n* Study 1b (Feasibility phase): A one-armed feasibility trial assessing the implementation and acceptability of the intervention among patients with muscle-invasive bladder cancer (MIBC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria study 1a:\n\n* The participant has one of the following diagnoses and received initial treatment approximately 12 months ago:\n\n 1. Non-muscle-invasive bladder cancer treated with transurethral resection of the bladder (TUR-B)\n 2. Non-muscle-invasive bladder cancer treated with TUR-B and subsequent intravesical instillation therapy with chemotherapy or immunotherapy\n 3. Muscle-invasive bladder cancer treated with cystectomy (removal of the bladder)\n* The participant has experienced changes and/or difficulties in sexual function related to the cancer diagnosis and/or its treatment\n* The participant speaks and understands Danish\n* The participant is aged 18 years or older\n* The participant has read and understood the oral and written study information\n* The participant has provided written informed consent\n\nExclusion Criteria study 1a:\n\n* 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\n* The participant has a history of breast cancer\n\nInclusion Criteria study 1b:\n\n* The participant is diagnosed with Muscle-invasive bladder cancer treated with cystectomy (removal of the bladder)\n* The participant speaks and understands Danish\n* The participant is aged 18 years or older\n* The participant has read and understood the oral and written study information\n* The participant has provided written informed consent\n\nExclusion Criteria study 1b:\n\n* 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\n* The participant has a history of breast cancer'}, 'identificationModule': {'nctId': 'NCT07339761', 'acronym': 'SPICE', 'briefTitle': 'Supporting Sexual Health in Bladder Cancer Patients: A Sequential Mixed-Methods Intervention Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'SPICE: Supporting Sexual Health in Bladder Cancer Patients: A Sequential Mixed-Methods Intervention Study', 'orgStudyIdInfo': {'id': 'DUAUHSPICE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm (study 1b)', 'interventionNames': ['Other: Sexological Support']}], 'interventions': [{'name': 'Sexological Support', 'type': 'OTHER', 'description': 'Results from Study 1a will inform the development and refinement of the intervention to be tested in the feasibility phase (Study 1b).', 'armGroupLabels': ['Intervention arm (study 1b)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Department of Urology, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'centralContacts': [{'name': 'Charlotte Graugaard-Jensen', 'role': 'CONTACT', 'email': 'Charlotte.Graugaard-Jensen@rm.dk', 'phone': '+45'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}