Clinical trial · Interventional
Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer
Psychosexual Intervention for Gynecologic and Breast Cancer Patients
NCT01764802CI-TRIAL-00033134completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized phase II trial studies how well psychosexual intervention works in patients with stage I-III gynecologic or breast cancer. Psychosexual intervention may improve sexual and psychosocial function.
Conditions
Conditions (62)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Sarcoma | Ovarian Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Stromal Cancer | Malignant Ovarian Epithelial Tumor | ALIAS | 0.90 |
| Stage IA Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IA Endometrial Carcinoma | Endometrial Carcinoma | CURATED_BROADER | 0.78 |
| Stage IA Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | CURATED_BROADER | 0.78 |
| Stage IA Ovarian Epithelial Cancer | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
| Stage IA Ovarian Germ Cell Tumor | Ovarian Germ Cell Tumor | CURATED_BROADER | 0.78 |
| Stage IA Primary Peritoneal Cavity Cancer |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| behavioral, psychological or informational intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (enhanced standard care)
- description
- Patients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding cancer treatments and sexuality delivered over two sessions.
- interventionNames
- Other: behavioral, psychological or informational intervention
- type
- EXPERIMENTAL
- label
- Arm II (psychological intervention)
- description
- Patients participate in individual or group therapy over 1.5 hours weekly for 6 weeks, bi-weekly for 8 weeks, and monthly for 2 months and complete assessment interviews.
- interventionNames
- Other: behavioral, psychological or informational intervention
Primary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Stage I-III gynecologic (any site) or breast cancer * Able to speak/read English * Able to give informed consent Exclusion Criteria: * Prior non-gynecologic/breast cancer diagnosis * Refusal of any cancer treatment(s) * Non-ambulatory * Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or significant sensory deficit * Major mental illness (e.g, schizophrenia, major depressive disorder) * Current/recent (prior 12 months) pregnancy * Residence \> 70 miles from research site
References
Publications (1)
- DERIVEDBlack LL, Conroy K, Lustberg M, Salani R, Andersen BL, Carpenter KM. Association of sexual pain and psychological factors among gynecologic and breast cancer patients: application of components of the fear-avoidance model of chronic pain. J Behav Med. 2025 Jun;48(3):536-543. doi: 10.1007/s10865-025-00560-3. Epub 2025 Mar 13. PMID 40082377