CompletedPhase 2

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

United States100 participantsStarted 2010-10

Plain-language 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.

Who can participate

Age range21 Years – 80 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Sexual behavior/repertoire (kissing, intercourse, etc.) graded using the Sexual Experiences Scale (SES)

Timeframe: Up to 2 months

Sexual responsiveness (desire, arousal, orgasm) using the Female Sexual Functioning Index (FSFI)

Timeframe: Up to 4 weeks

Sexual satisfaction graded using the global evaluation from the Derogatis Sexual Function Inventory (DSFI)

Timeframe: Up to 2 months

Sexual distress graded using the female Sexual Distress Scale (FSDS)

Timeframe: Up to 4 weeks

Sexual pain graded using the International Pelvic Pain Society Pelvic Pain Assessment, patient/physician version

Timeframe: Up to 9 months

Trial details

NCT IDNCT01764802

SponsorOhio State University Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-06-01

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