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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01341 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 1R21CA149675-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVES:
I. Efficacy for reducing the severity of sexual distress, difficulty, and dysfunction in a phase II randomized clinical trial (RCT).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (Enhanced standard care): Patients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding gynecologic or breast cancer treatments and sexuality, and provision of a survivorship care plan (SCP) created using OncoLink over 1 hour following baseline assessment and before 6 months.
ARM II (Psychological intervention): Patients participate in individual or group therapy over 1.5 hours weekly for 4 weeks, bi-weekly for 8 weeks, and monthly for 2 months and complete assessment interviews.
After completion of study treatment, patients are followed up at 3, 6, and 9 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (enhanced standard care) | Active Comparator | Patients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding cancer treatments and sexuality delivered over two sessions. |
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| Arm II (psychological intervention) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| behavioral, psychological or informational intervention | Other | Participate in enhanced standard care |
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| Measure | Description | Time Frame |
|---|---|---|
| Sexual behavior/repertoire (kissing, intercourse, etc.) graded using the Sexual Experiences Scale (SES) | Multilevel modeling will be used to model time effects compared to repeated-measures analysis of variance (ANOVA) because it allows not only fitting different patterns of average change (i.e., linear, quadratic), but also estimates individual variability in the rate of change. Both linear and quadratic change models will be tested and an optimal model will be determined. 95% confidence intervals will be obtained. | Up to 2 months |
| Sexual responsiveness (desire, arousal, orgasm) using the Female Sexual Functioning Index (FSFI) | Principal components analysis yields six subscales: desire, arousal, lubrication, orgasm, satisfaction, and pain. Items are rated using the Likert scales. 95% confidence intervals will be obtained. | Up to 4 weeks |
| Sexual satisfaction graded using the global evaluation from the Derogatis Sexual Function Inventory (DSFI) | 95% confidence intervals will be obtained. | Up to 2 months |
| Sexual distress graded using the female Sexual Distress Scale (FSDS) | The Likert scale will be used. 95% confidence intervals will be obtained. | Up to 4 weeks |
| Sexual pain graded using the International Pelvic Pain Society Pelvic Pain Assessment, patient/physician version | Up to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Emotional distress graded using the Profile of Mood States (POMS) | The Likert scale will be used. 95% confidence intervals will be obtained. | Up to 9 months |
| Depressive symptoms graded using the Center for Epidemiologic Studies Depression Scale (CES-D) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristen M. Carpenter, Ph.D | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40082377 | Derived | Black 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. |
| Label | URL |
|---|---|
| Jamesline | View source |
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| behavioral, psychological or informational intervention | Other | Participate in psychological intervention |
|
The Likert scale will be used. 95% confidence intervals will be obtained. |
| Up to 9 months |
| Health-related quality of life graded according to the RAND Medical Outcomes Study, Short-form 12 (SF-12) | The eight primary subscales are summarized into two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). | Up to 9 months |
| Cancer-related stress graded according to the Impact of Events Scale-Revised (IES-R) | Up to 9 months |
| Body change stress graded according to the Impact of Treatment Scale (ITS) | Up to 9 months |
| ID | Term |
|---|---|
| D014625 | Vaginal Neoplasms |
| D014846 | Vulvar Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| D031901 | Gestational Trophoblastic Disease |
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014845 | Vulvar Diseases |
| D014594 | Uterine Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014328 | Trophoblastic Neoplasms |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D011252 | Pregnancy Complications, Neoplastic |
| D011248 | Pregnancy Complications |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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