Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer

Phase 2

Completed

• Conditions: Ovarian Sarcoma; Stage I Uterine Sarcoma; Stage I Vulvar Cancer; Stage IA Ovarian Epithelial Cancer; Stage IC Fallopian Tube Cancer; Stage IIA Fallopian Tube Cancer; Stage IIA Ovarian Germ Cell Tumor; Stage IIIA Ovarian Germ Cell Tumor; Stage IIIB Endometrial Carcinoma; Stage IIIB Fallopian Tube Cancer
• Interventions: Other: behavioral, psychological or informational intervention

• Registration Number: NCT01764802
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-01-09
• Study First Posted: 2013-01-10
• Primary Completion: 2017-06-01
• Study Completion: 2017-06-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-25
• Last Update Posted: 2018-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (enhanced standard care)	behavioral, psychological or informational intervention	Patients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding cancer treatments and sexuality delivered over two sessions.
Arm II (psychological intervention)	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.

Primary Outcome Measures

Name	Time	Method
Sexual satisfaction graded using the global evaluation from the Derogatis Sexual Function Inventory (DSFI)	Up to 2 months	95% confidence intervals will be obtained.
Sexual distress graded using the female Sexual Distress Scale (FSDS)	Up to 4 weeks	The Likert scale will be used. 95% confidence intervals will be obtained.
Sexual behavior/repertoire (kissing, intercourse, etc.) graded using the Sexual Experiences Scale (SES)	Up to 2 months	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.
Sexual responsiveness (desire, arousal, orgasm) using the Female Sexual Functioning Index (FSFI)	Up to 4 weeks	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.
Sexual pain graded using the International Pelvic Pain Society Pelvic Pain Assessment, patient/physician version	Up to 9 months

Secondary Outcome Measures

Name	Time	Method
Body change stress graded according to the Impact of Treatment Scale (ITS)	Up to 9 months
Health-related quality of life graded according to the RAND Medical Outcomes Study, Short-form 12 (SF-12)	Up to 9 months	The eight primary subscales are summarized into two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Depressive symptoms graded using the Center for Epidemiologic Studies Depression Scale (CES-D)	Up to 9 months	The Likert scale will be used. 95% confidence intervals will be obtained.
Cancer-related stress graded according to the Impact of Events Scale-Revised (IES-R)	Up to 9 months
Emotional distress graded using the Profile of Mood States (POMS)	Up to 9 months	The Likert scale will be used. 95% confidence intervals will be obtained.

Trial Locations

Locations (1)

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States