A Phase 2 interventional study of behavioral, psychological or informational intervention and behavioral, psychological or informational intervention in Ovarian Sarcoma, Ovarian Stromal Cancer and Stage I Uterine Sarcoma, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to female participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-05-30.
Sponsored by Ohio State University Comprehensive Cancer Center · Phase 2, Interventional, and Supportive care
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.
Exclusion Criteria:
Patients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding cancer treatments and sexuality delivered over two sessions.
Other: behavioral, psychological or informational intervention
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.
Other: behavioral, psychological or informational intervention
Participate in enhanced standard care
Participate in psychological intervention
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.
Time frame: 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.
Time frame: Up to 4 weeks
Sexual satisfaction graded using the global evaluation from the Derogatis Sexual Function Inventory (DSFI)
95% confidence intervals will be obtained.
Time frame: 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.
Time frame: Up to 4 weeks
Sexual pain graded using the International Pelvic Pain Society Pelvic Pain Assessment, patient/physician version
Time frame: Up to 9 months
Emotional distress graded using the Profile of Mood States (POMS)
The Likert scale will be used. 95% confidence intervals will be obtained.
Time frame: Up to 9 months
Depressive symptoms graded using the Center for Epidemiologic Studies Depression Scale (CES-D)
The Likert scale will be used. 95% confidence intervals will be obtained.
Time frame: 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).
Time frame: Up to 9 months
Cancer-related stress graded according to the Impact of Events Scale-Revised (IES-R)
Time frame: Up to 9 months
Body change stress graded according to the Impact of Treatment Scale (ITS)
Time frame: Up to 9 months
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Ohio State University Comprehensive Cancer Center