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
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Among 87 studies in Vaginal Neoplasms with a site in United States — 13 open to participants now, 19 under way, 1 of them phase 3. Vaginal Neoplasms · United States.
Among the 87 studies in Vaginal Neoplasms with a site in United States, this one is the 11th largest by enrollment of the 68 interventional ones that give a count, is one of 2 that started in 2010, is one of 18 in phase 2, and was the 42nd registered.
159 studies on the registry are indexed under Vaginal Neoplasms; 39 are open to participants now.
Browse Vaginal Neoplasms studies →13 of the 87 studies in Vaginal Neoplasms with a site in United States are open now. Recruiting first, the newest first:
City of Hope Medical Center · Sites in United States
Ages 18+ · Women only
Ohio State University Comprehensive Cancer Center · Sites in United States
Ages 50+ · Women only
AstraZeneca · Sites in United States
Ages 18–130
Christian Hinrichs · Sites in United States
Ages 18+
Dana-Farber Cancer Institute · Sites in United States
Ages 18+ · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 34 Vaginal Neoplasms studies recruiting now, 20 (59%) set no upper age limit and 9 (26%) stop at 75 or younger; 5 take children under 18; 6 take healthy volunteers.
This study: 21 Years to 80 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
87 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 27 · Phase 2 21 · Phase 3 3
First in 1992; this study’s year is marked. 2 started in 2010.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 100 is above the median of 51 across 118 interventional studies indexed under Vaginal Neoplasms.
Median enrollment 28 across the 68 interventional studies, 209 across the 16 observational. Of the 63 that completed or were terminated, 15 (24%) have results posted.
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7 of 87 have an industry lead sponsor. The 10 most frequent:
Ohio State University Comprehensive Cancer Center is the lead sponsor of 377 studies on the registry; 83 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
Ohio State University Comprehensive Cancer Center has 6 studies filed under Vaginal Neoplasms — fewer than ten, so there is no comparison to draw.
8 of the studies in Vaginal Neoplasms with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05979610University of UtahUsing Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies | 2026-12 |
| NCT02993900Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsImage-Guided Gynecologic Brachytherapy | 2026-12 |
| NCT06677190Dana-Farber Cancer InstituteBelzutifan in Recurrent Clear Cell Carcinoma of Gynecologic Origin | 2026-12-30 |
| NCT07407647Ohio State University Comprehensive Cancer CenterVaginal DHEA to Improve Vaginal Health After Radiation for Women With Gynecologic, Anal or Rectal Cancer | 2026-12-31 |
| NCT05786456City of Hope Medical Centere-Health Intervention (Day-by-Day) for the Management of Fear of Progression in Women With Stage III or IV Gynecologic Cancer: A Pilot Study | 2027-01-01 |
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Among the 87 studies in Vaginal Neoplasms with a site in United States, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
The record gives a start of Oct 2010, a primary completion of Jun 2017 and a completion of Jun 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
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 →