Ovarian SarcomaPhase 2NCT01764802
Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer
A Phase 2 study testing behavioral, psychological or informational intervention in people with Ovarian Sarcoma and Ovarian Stromal Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years, women only
- Conditions the study is for
- Ovarian Sarcoma, Ovarian Stromal Cancer, Stage I Uterine Sarcoma
- What is being tested?
- behavioral, psychological or informational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to 1 Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage I-III gynecologic (any site) or breast cancer
- Able to speak/read English
- Able to give informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Psychosexual Intervention for Gynecologic and Breast Cancer Patients
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Ovarian Sarcoma, Ovarian Stromal Cancer, Stage I Uterine Sarcoma, Stage I Vaginal Cancer, Stage I Vulvar Cancer, Stage IA Cervical Cancer
- Being tested
- behavioral, psychological or informational intervention
- Keywords
- Psychosexual Intervention, Cancer, Gynecologic Cancer, Breast Cancer
- Medical subject headings
- Vaginal Neoplasms, Vulvar Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial, Gestational Trophoblastic Disease, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral, psychological or informational interventionOther
Participate in enhanced standard care
behavioral, psychological or informational interventionOther
Participate in psychological intervention
| Study group | Role | What they receive |
|---|---|---|
| Arm I (enhanced standard care) | Active comparator | Patients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding cancer treatments and sexuality delivered over two sessions. Receives: Other: behavioral, psychological or informational intervention |
| Arm II (psychological intervention) | Experimental | 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. Receives: Other: behavioral, psychological or informational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 4 weeks
Sexual satisfaction graded using the global evaluation from the Derogatis Sexual Function Inventory (DSFI)
95% confidence intervals will be obtained.
Measured: 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.
Measured: Up to 4 weeks
Sexual pain graded using the International Pelvic Pain Society Pelvic Pain Assessment, patient/physician version
Measured: Up to 9 months
Secondary outcomes (5)
Emotional distress graded using the Profile of Mood States (POMS)
The Likert scale will be used. 95% confidence intervals will be obtained.
Measured: 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.
Measured: 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).
Measured: Up to 9 months
Cancer-related stress graded according to the Impact of Events Scale-Revised (IES-R)
Measured: Up to 9 months
Body change stress graded according to the Impact of Treatment Scale (ITS)
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startOct 2010
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian SarcomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kristen Carpenter, Ohio State University Comprehensive Cancer Center
- Investigators
- Kristen M. Carpenter, Ph.D, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764802
- Sponsor's protocol ID
- OSU-10077
- Other IDs
- NCI-2012-01341, 1R21CA149675-01A1
- Status last verified
- May 2018
- First submitted
- 8 Jan 2013
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Black LL, Conroy K, Lustberg M, Salani R, Andersen BL, Carpenter KM. Association of sexual pain and psychological factors among gynecologic and breast cancer patients: application of components of the fear-avoidance model of chronic pain. J Behav Med. 2025 Jun;48(3):536-543. doi: 10.1007/s10865-025-00560-3. Epub 2025 Mar 13.
PubMed 40082377
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosexual Intervention for Gynecologic and Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT01764802
- Acronym / sponsor ID
- OSU-10077
- Conditions
- Ovarian Sarcoma, Ovarian Stromal Cancer, Stage I Uterine Sarcoma, Stage I Vaginal Cancer, Stage I Vulvar Cancer, Stage IA Cervical Cancer
- Keywords
- Psychosexual Intervention, Cancer, Gynecologic Cancer, Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2010
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 10 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (enhanced standard care) | Active comparator | Other: behavioral, psychological or informational interventionPatients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding cancer treatments and sexuality delivered over two sessions. |
| Arm II (psychological intervention) | Experimental | Other: behavioral, psychological or informational interventionPatients 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stage I-III gynecologic (any site) or breast cancer
- Able to speak/read English
- Able to give informed consent
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral, psychological or informational interventionParticipate in enhanced standard care | Other | Arm I (enhanced standard care) |
| behavioral, psychological or informational interventionParticipate in psychological intervention | Other | Arm II (psychological intervention) |
Primary outcome
Sexual behavior/repertoire (kissing, intercourse, etc.) graded using the Sexual Experiences Scale (SES)
Time frame: 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)
Time frame: 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 satisfaction graded using the global evaluation from the Derogatis Sexual Function Inventory (DSFI)
Time frame: Up to 2 months
95% confidence intervals will be obtained.
Sexual distress graded using the female Sexual Distress Scale (FSDS)
Time frame: Up to 4 weeks
The Likert scale will be used. 95% confidence intervals will be obtained.
Sexual pain graded using the International Pelvic Pain Society Pelvic Pain Assessment, patient/physician version
Time frame: Up to 9 months
5 secondary outcomes
Emotional distress graded using the Profile of Mood States (POMS)
Time frame: Up to 9 months
Depressive symptoms graded using the Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Up to 9 months
Health-related quality of life graded according to the RAND Medical Outcomes Study, Short-form 12 (SF-12)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Derived from this study: PubMed 40082377Black LL, Conroy K, Lustberg M, Salani R, Andersen BL, Carpenter KM. Association of sexual pain and psychological factors among gynecologic and breast cancer patients: application of components of the fear-avoidance model of chronic pain. J Behav Med. 2025 Jun;48(3):536-543. doi: 10.1007/s10865-025-00560-3. Epub 2025 Mar 13.
- JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen M. Carpenter, Ph.D principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing behavioral, psychological or informational intervention in people with Ovarian Sarcoma and Ovarian Stromal Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual behavior/repertoire (kissing, intercourse, etc.) graded using the Sexual Experiences Scale (SES) (time frame: Up to 2 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01764802, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.