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 range

21 Years – 80 Years

Sex

FEMALE

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Ovarian Sarcoma trials

Who can participate

Age range

21 Years – 80 Years

Sex

FEMALE

See this in plain English?

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